<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01706263</url>
  </required_header>
  <id_info>
    <org_study_id>114551</org_study_id>
    <nct_id>NCT01706263</nct_id>
  </id_info>
  <brief_title>U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne</brief_title>
  <official_title>U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stiefel, a GSK Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      One of the main success factors in acne therapy is user compliance with treatment, product&#xD;
      cost, availability and ease of use. Poor compliance may translate into decreased efficacy&#xD;
      (either not improving symptoms well enough or not improving symptoms fast enough),&#xD;
      tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a&#xD;
      lack of understanding of the instructions for use, or product cost/availability. Whatever the&#xD;
      reason, poor compliance translates to decreased efficacy and increased frustration on the&#xD;
      part of the user.&#xD;
&#xD;
      The current study will evaluate the efficacy and tolerability of MAXCLARITY II, an over the&#xD;
      counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acne vulgaris is an extremely common dermatological disease that is found typically in&#xD;
      adolescence and young adulthood. Acne vulgaris manifests with open and closed comedones&#xD;
      (blackheads and whiteheads), papules, pustules, nodules, and cysts on the face, neck, and&#xD;
      trunk. Scarring can occur, particularly if the lesions are inflamed and deep, even in the&#xD;
      absence of external manipulation (eg, picking and squeezing) of the skin.&#xD;
&#xD;
      Acne vulgaris can be treated with a variety of agents that are selected to address the&#xD;
      pathogenic factors assumed to be responsible for the type and degree of manifested acne&#xD;
      lesions. Monotherapy and combination therapy regimens are both useful. Topical agents are&#xD;
      generally used as first-line therapy and include retinoids, antibiotic preparations (eg,&#xD;
      erythromycin and clindamycin), benzoyl peroxide (BPO), alpha and beta hydroxy acids (eg,&#xD;
      glycolic and salicylic acid preparations), and azelaic acid. Systemic therapies are initiated&#xD;
      in patients with moderate to severe inflammatory acne that does not respond to topical&#xD;
      therapy.&#xD;
&#xD;
      Benzoyl peroxide has antimicrobial and anti inflammatory properties and is often considered&#xD;
      an important component of acne treatment. Benzoyl peroxide is frequently the first product&#xD;
      that adolescents will use for acne because it can be purchased without a prescription in&#xD;
      several different concentrations and formulations.&#xD;
&#xD;
      One of the main success factors in acne therapy is user compliance with treatment, product&#xD;
      cost, availability and ease of use. Poor compliance may translate into decreased efficacy&#xD;
      (either not improving symptoms well enough or not improving symptoms fast enough),&#xD;
      tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a&#xD;
      lack of understanding of the instructions for use, or product cost/availability. Whatever the&#xD;
      reason, poor compliance translates to decreased efficacy and increased frustration on the&#xD;
      part of the user.&#xD;
&#xD;
      The current study will evaluate the efficacy and tolerability of MAXCLARITY II, an over the&#xD;
      counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.&#xD;
&#xD;
      This is a multi center, open label study to evaluate the efficacy and tolerability of&#xD;
      MAXCLARITY II, an over the-counter, topical benzoyl peroxide product line, in subjects with&#xD;
      acne. Approximately 30 subjects, aged from 16 to 29 years, inclusive, with mild facial acne&#xD;
      vulgaris are expected to participate in the study. No more than 50% of the subjects at each&#xD;
      site can be enrolled under the age of 20.&#xD;
&#xD;
      An expert grader will complete counts of inflamed lesions (papules/pustules) and noninflamed&#xD;
      lesions (open/closed comedones), the ISGA, and an assessment of tolerability at each study&#xD;
      visit. Subjects will assess tolerability at each study visit and will complete a product&#xD;
      acceptability and preference questionnaire at the end of the study.&#xD;
&#xD;
      The study duration will be 8 weeks (56 days) with visits at baseline (day 1), week 1, week 2,&#xD;
      week 4 and week 8.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2009</start_date>
  <completion_date type="Actual">November 20, 2009</completion_date>
  <primary_completion_date type="Actual">November 20, 2009</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8</measure>
    <time_frame>Baseline (Day 1) and Week 8</time_frame>
    <description>Evaluator assessed the left and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open [blackheads] and closed [whiteheads] comedones) and total lesions (sum of inflammatory and non-inflammatory lesion) for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4</measure>
    <time_frame>Baseline (Day 1) and Week 1, 2, 4</time_frame>
    <description>Evaluator assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts was calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to specified time (Weeks 1, 2, and 4) point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Weeks 1, 2, 4 and 8</measure>
    <time_frame>Baseline (Day 1) and Week 1, 2, 4, 8</time_frame>
    <description>Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Improved by at Least One Grade on the ISGA</measure>
    <time_frame>Up to Week 8</time_frame>
    <description>Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to specified time point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.</measure>
    <time_frame>Baseline (Day 1) and Week 1, 2, 4, 8</time_frame>
    <description>Erythema , dryness, and peeling, were evaluated independently by the investigator on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8</measure>
    <time_frame>Baseline (Day 1) and Week 1, 2, 4, 8</time_frame>
    <description>Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>MAXCLARITY II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam. Available over-the-counter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MAXCLARITY II (2.5% BPO) Foam Cleanser</intervention_name>
    <description>Available over the counter.</description>
    <arm_group_label>MAXCLARITY II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MAXCLARITY II (2.5% BPO) Foam Treatment</intervention_name>
    <description>Available over the counter.</description>
    <arm_group_label>MAXCLARITY II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MAXCLARITY II (0.5% Salicylic Acid) Toner Foam</intervention_name>
    <description>Available over the counter.</description>
    <arm_group_label>MAXCLARITY II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Capable of understanding and willing to provide signed and dated written voluntary&#xD;
             informed consent (and any local or national authorization requirements) before any&#xD;
             protocol specific procedures are performed.&#xD;
&#xD;
          2. Male or female aged from 16 to 29 years, inclusive, at time of consent. No more than&#xD;
             50% of the subjects at each site can be enrolled under the age of 20.&#xD;
&#xD;
          3. Mild facial acne vulgaris, characterized by at least 24 facial inflammatory lesions&#xD;
             (papules and pustules) and/or noninflammatory lesions (open and closed comedones) on&#xD;
             the face.&#xD;
&#xD;
          4. Able to complete the study and to comply with study instructions.&#xD;
&#xD;
          5. Sexually active females of childbearing potential participating in the study must&#xD;
             agree to use a medically acceptable method of contraception while receiving&#xD;
             protocol-assigned product. A woman of childbearing potential is defined as one who is&#xD;
             biologically capable of becoming pregnant; including perimenopausal women who are less&#xD;
             than 2 years from their last menses. Acceptable contraceptive methods include the&#xD;
             following:&#xD;
&#xD;
               -  Hormonal contraception, including oral, injectable, or implantable methods&#xD;
                  started at least 2 months prior to screening. If hormonal contraception was&#xD;
                  started less than 2 months prior to screening, then a form of nonhormonal&#xD;
                  contraception should be added until the third continuous month of hormonal&#xD;
                  contraception has been completed.&#xD;
&#xD;
               -  Two forms of reliable nonhormonal contraception, to include the use of either an&#xD;
                  intrauterine device plus a reliable barrier method or 2 reliable barrier methods.&#xD;
                  Reliable barrier methods include condoms or diaphragms. A cervical cap is also a&#xD;
                  reliable barrier method, provided that the female subject has never given birth&#xD;
                  naturally. The combined use of a condom and spermicide constitute 2 forms of&#xD;
                  acceptable nonhormonal contraception, provided that they are both used properly.&#xD;
                  The use of spermicide alone and the improper use of condoms are inferior methods&#xD;
                  of contraception. Subjects with surgical sterilization, including tubal&#xD;
                  sterilization or partner's vasectomy, must use a form of nonhormonal&#xD;
                  contraception. A barrier method or sterilization plus spermatocide is acceptable.&#xD;
&#xD;
               -  Women who are not currently sexually active must agree to use a medically&#xD;
                  accepted method of contraception should she become sexually active while&#xD;
                  participating in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female who is pregnant, trying to become pregnant, or breast feeding.&#xD;
&#xD;
          2. Has active or chronic skin allergies.&#xD;
&#xD;
          3. Has a history of acute or chronic disease that might interfere with or increase the&#xD;
             risk of study participation.&#xD;
&#xD;
          4. Had skin cancer treatment in preceding 12 months.&#xD;
&#xD;
          5. Has damaged skin on facial areas (eg, sunburn, tattoo, or scar)&#xD;
&#xD;
          6. Had any medical procedure (eg, laser resurfacing, chemical peel, or plastic surgery)&#xD;
             on facial areas in preceding 12 months.&#xD;
&#xD;
          7. Had any cosmetic procedure (eg, microdermabrasion) on facial areas within 8 weeks of&#xD;
             the baseline visit.&#xD;
&#xD;
          8. Has any dermatological disorder that in the opinion of the investigator may interfere&#xD;
             with the accurate evaluation of the subject's facial appearance.&#xD;
&#xD;
          9. Received any investigational drug or procedure within 28 days of the baseline visit or&#xD;
             is scheduled to receive an investigational drug (other than the study products) or&#xD;
             procedure during the study.&#xD;
&#xD;
         10. Currently using any medication that in the opinion of the investigator may affect the&#xD;
             evaluation of the study products or place the subject at undue risk (including but not&#xD;
             limited to asthma medications, oral steroids, rifampin, anticonvulsants, and St John's&#xD;
             wart).&#xD;
&#xD;
         11. Has a history of known or suspected intolerance to any of the ingredients of the study&#xD;
             products (ie, benzoyl peroxide).&#xD;
&#xD;
         12. Considered unable or unlikely to attend the necessary visits.&#xD;
&#xD;
         13. Live in the same household as currently enrolled subjects.&#xD;
&#xD;
         14. Employee of the investigator, a contract research organization, or Stiefel&#xD;
             Laboratories who is involved in the study, or an immediate family member (partner,&#xD;
             offspring, parents, siblings or sibling's offspring) of an employee involved in the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <link>
    <url>https://www.clinicalstudydatarequest.com</url>
    <description>Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.</description>
  </link>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>July 18, 2017</results_first_submitted>
  <results_first_submitted_qc>January 5, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 8, 2018</results_first_posted>
  <last_update_submitted>January 5, 2018</last_update_submitted>
  <last_update_submitted_qc>January 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salicylic Acid</mesh_term>
    <mesh_term>Salicylates</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>114551</doc_id>
      <doc_type>Annotated Case Report Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>114551</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>114551</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>114551</doc_id>
      <doc_type>Dataset Specification</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>114551</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>114551</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Male or female participants aged from 18 to 29 years with mild facial acne vulgaris were enrolled in this study. The study was conducted at three different study centers. Study period was 8 Weeks (56 days) and study conducted from 19 August 2009 to 01 December 2009.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>MAXCLARITY II</title>
          <description>The eligible participants applied a small amount of the MAXCLARITY II™ 2.5 percent (%) benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MAXCLARITY II</title>
          <description>The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="28"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.7" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8</title>
        <description>Evaluator assessed the left and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open [blackheads] and closed [whiteheads] comedones) and total lesions (sum of inflammatory and non-inflammatory lesion) for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .</description>
        <time_frame>Baseline (Day 1) and Week 8</time_frame>
        <population>Intent-to-treat analysis set was used which included data from all randomized participants who received study product.</population>
        <group_list>
          <group group_id="O1">
            <title>MAXCLARITY II</title>
            <description>The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8</title>
          <description>Evaluator assessed the left and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open [blackheads] and closed [whiteheads] comedones) and total lesions (sum of inflammatory and non-inflammatory lesion) for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .</description>
          <population>Intent-to-treat analysis set was used which included data from all randomized participants who received study product.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Inflammatory lesion count</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-62.1" spread="37.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Inflammatory lesion count</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-49.8" spread="39.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total lesion count</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-56.9" spread="32.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4</title>
        <description>Evaluator assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts was calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to specified time (Weeks 1, 2, and 4) point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .</description>
        <time_frame>Baseline (Day 1) and Week 1, 2, 4</time_frame>
        <population>Intent-to-treat analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>MAXCLARITY II</title>
            <description>The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4</title>
          <description>Evaluator assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts was calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to specified time (Weeks 1, 2, and 4) point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .</description>
          <population>Intent-to-treat analysis set.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Inflammatory lesion count, Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.9" spread="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inflammatory lesion count, Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-50.8" spread="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inflammatory lesion count, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-49.5" spread="30.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Inflammatory lesion count, Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.9" spread="45.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Inflammatory lesion count, Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.4" spread="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Inflammatory lesion count, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-34.3" spread="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total lesion count, Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.6" spread="27.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total lesion count, Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.8" spread="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total lesion count, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-44.9" spread="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Weeks 1, 2, 4 and 8</title>
        <description>Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .</description>
        <time_frame>Baseline (Day 1) and Week 1, 2, 4, 8</time_frame>
        <population>Intent-to-treat analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>MAXCLARITY II</title>
            <description>The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Weeks 1, 2, 4 and 8</title>
          <description>Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .</description>
          <population>Intent-to-treat analysis set.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ISGA score, Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISGA score, Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.46" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISGA score, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.39" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISGA score, Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.61" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Improved by at Least One Grade on the ISGA</title>
        <description>Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to specified time point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .</description>
        <time_frame>Up to Week 8</time_frame>
        <population>Intent-to-treat analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>MAXCLARITY II</title>
            <description>The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule..</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Improved by at Least One Grade on the ISGA</title>
          <description>Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to specified time point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .</description>
          <population>Intent-to-treat analysis set.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Atleast one grade improvement,Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Atleast two grade improvement,Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Atleast one grade improvement,Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Atleast two grade improvement,Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Atleast one grade improvement,Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Atleast two grade improvement,Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Atleast one grade improvement,Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Atleast two grade improvement,Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.</title>
        <description>Erythema , dryness, and peeling, were evaluated independently by the investigator on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .</description>
        <time_frame>Baseline (Day 1) and Week 1, 2, 4, 8</time_frame>
        <population>Intent-to-treat analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>MAXCLARITY II</title>
            <description>The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.</title>
          <description>Erythema , dryness, and peeling, were evaluated independently by the investigator on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .</description>
          <population>Intent-to-treat analysis set.</population>
          <units>Score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Erythema, Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema, Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema, Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.32" spread="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness, Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness, Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.32" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness, Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peeling, Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peeling, Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peeling, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Peeling, Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8</title>
        <description>Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .</description>
        <time_frame>Baseline (Day 1) and Week 1, 2, 4, 8</time_frame>
        <population>Intent-to-treat analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>MAXCLARITY II</title>
            <description>The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8</title>
          <description>Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .</description>
          <population>Intent-to-treat analysis set.</population>
          <units>Score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Redness,Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.39" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness,Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.25" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness,Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness,Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.36" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness,Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="1.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness,Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness,Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dryness,Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Burning,Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Burning,Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.36" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Burning,Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.32" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Burning,Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching,Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching,Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching,Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching,Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Scaling,Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Scaling,Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Scaling,Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Scaling,Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events and serious adverse events were reported throughout the study (from Baseline Up to Week 8)</time_frame>
      <desc>Intent-to-treat analysis set was used to report adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>MAXCLARITY II</title>
          <description>The eligible participants applied a small amount of the MAXCLARITY II 2.5 % benzyl peroxide foam cleanser and foam treatment, 0.5% salicylic acid toner foam. Participants applied foam cleanser each morning to the dampened skin and gently massaged over whole face followed by thorough wash with warm water. The participants then applied small amount of MAXCLARITY II foam treatment in a thin layer to the entire face (avoiding the eyes, lips, and mouth) each morning. In the evening the participants washed their face with MAXCLARITY II Foam cleanser and then applied MAXCLARITY II toner foam to the face each evening. Study products were applied once daily for 8 weeks. If any dose was missed, the next dose was administered according to original schedule.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 12.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application Site Burning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Skin Laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01706263
org study id: 114551
nct id: NCT01706263
lead sponsor: 
collaborator: 
has dmc: No
One of the main success factors in acne therapy is user compliance with treatment, product
      cost, availability and ease of use. Poor compliance may translate into decreased efficacy
      (either not improving symptoms well enough or not improving symptoms fast enough),
      tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a
      lack of understanding of the instructions for use, or product cost/availability. Whatever the
      reason, poor compliance translates to decreased efficacy and increased frustration on the
      part of the user.

      The current study will evaluate the efficacy and tolerability of MAXCLARITY II, an over the
      counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.
Acne vulgaris is an extremely common dermatological disease that is found typically in
      adolescence and young adulthood. Acne vulgaris manifests with open and closed comedones
      (blackheads and whiteheads), papules, pustules, nodules, and cysts on the face, neck, and
      trunk. Scarring can occur, particularly if the lesions are inflamed and deep, even in the
      absence of external manipulation (eg, picking and squeezing) of the skin.

      Acne vulgaris can be treated with a variety of agents that are selected to address the
      pathogenic factors assumed to be responsible for the type and degree of manifested acne
      lesions. Monotherapy and combination therapy regimens are both useful. Topical agents are
      generally used as first-line therapy and include retinoids, antibiotic preparations (eg,
      erythromycin and clindamycin), benzoyl peroxide (BPO), alpha and beta hydroxy acids (eg,
      glycolic and salicylic acid preparations), and azelaic acid. Systemic therapies are initiated
      in patients with moderate to severe inflammatory acne that does not respond to topical
      therapy.

      Benzoyl peroxide has antimicrobial and anti inflammatory properties and is often considered
      an important component of acne treatment. Benzoyl peroxide is frequently the first product
      that adolescents will use for acne because it can be purchased without a prescription in
      several different concentrations and formulations.

      One of the main success factors in acne therapy is user compliance with treatment, product
      cost, availability and ease of use. Poor compliance may translate into decreased efficacy
      (either not improving symptoms well enough or not improving symptoms fast enough),
      tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a
      lack of understanding of the instructions for use, or product cost/availability. Whatever the
      reason, poor compliance translates to decreased efficacy and increased frustration on the
      part of the user.

      The current study will evaluate the efficacy and tolerability of MAXCLARITY II, an over the
      counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.

      This is a multi center, open label study to evaluate the efficacy and tolerability of
      MAXCLARITY II, an over the-counter, topical benzoyl peroxide product line, in subjects with
      acne. Approximately 30 subjects, aged from 16 to 29 years, inclusive, with mild facial acne
      vulgaris are expected to participate in the study. No more than 50% of the subjects at each
      site can be enrolled under the age of 20.

      An expert grader will complete counts of inflamed lesions (papules/pustules) and noninflamed
      lesions (open/closed comedones), the ISGA, and an assessment of tolerability at each study
      visit. Subjects will assess tolerability at each study visit and will complete a product
      acceptability and preference questionnaire at the end of the study.

      The study duration will be 8 weeks (56 days) with visits at baseline (day 1), week 1, week 2,
      week 4 and week 8.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8
time frame: Baseline (Day 1) and Week 8
description: Evaluator assessed the left and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open [blackheads] and closed [whiteheads] comedones) and total lesions (sum of inflammatory and non-inflammatory lesion) for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .
measure: Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4
time frame: Baseline (Day 1) and Week 1, 2, 4
description: Evaluator assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts was calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to specified time (Weeks 1, 2, and 4) point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .
measure: Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Weeks 1, 2, 4 and 8
time frame: Baseline (Day 1) and Week 1, 2, 4, 8
description: Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .
measure: Percentage of Participants Who Improved by at Least One Grade on the ISGA
time frame: Up to Week 8
description: Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to specified time point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .
measure: Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.
time frame: Baseline (Day 1) and Week 1, 2, 4, 8
description: Erythema , dryness, and peeling, were evaluated independently by the investigator on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .
measure: Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8
time frame: Baseline (Day 1) and Week 1, 2, 4, 8
description: Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .
arm group label: MAXCLARITY II
arm group type: Experimental
description: MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam. Available over-the-counter.
intervention type: Drug
intervention name: MAXCLARITY II (2.5% BPO) Foam Cleanser
description: Available over the counter.
arm group label: MAXCLARITY II
intervention type: Drug
intervention name: MAXCLARITY II (2.5% BPO) Foam Treatment
description: Available over the counter.
arm group label: MAXCLARITY II
intervention type: Drug
intervention name: MAXCLARITY II (0.5% Salicylic Acid) Toner Foam
description: Available over the counter.
arm group label: MAXCLARITY II
criteria: 
gender: All
minimum age: 16 Years
maximum age: 29 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
url: https://www.clinicalstudydatarequest.com
description: Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
responsible party type: Sponsor
mesh term: Acne Vulgaris
mesh term: Salicylic Acid
mesh term: Salicylates
sharing ipd: Yes
ipd description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
study doc: 
study doc: 
study doc: 
study doc: 
study doc: 
study doc: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 