<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/NCT03043534</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00034479</org_study_id>
    <nct_id>NCT03043534</nct_id>
  </id_info>
  <brief_title>Pre-Shave Gel and Brush in Pseudofolliculitis Barbae</brief_title>
  <official_title>The Impact of a Pre-Shave Gel and Brush in Males With Pseudofolliculitis Barbae</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a randomized investigator blinded study of 40 men age 20-60 (inclusive) with&#xD;
      symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects will be&#xD;
      divided into two groups: the Control group of 20 subjects and the Experimental group of 20&#xD;
      Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks.&#xD;
&#xD;
      All subjects will use their normal razors and shave products during the six week study. The&#xD;
      Experimental group of subjects will also be given the study product Pre-Shave Gel and&#xD;
      Cleansing Brush.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a randomized investigator blinded study of up to 40 men age 20-60 (inclusive)&#xD;
      with symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects&#xD;
      will be divided into two groups: the Control group of 20 subjects and the Experimental group&#xD;
      of 20 Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks.&#xD;
&#xD;
      All subjects will use their normal razors and shave products during the six week study. The&#xD;
      Experimental group of subjects will also be given the study product Pre-Shave Gel and&#xD;
      Cleansing Brush. The study gel and brush will be used prior to their normal shave&#xD;
      routine.Quantitative lesion counts will be done by trained clinicians at each visit. Efficacy&#xD;
      assessments include Investigator Global Assessment (IGA) scoring&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 12, 2015</start_date>
  <completion_date type="Actual">October 12, 2016</completion_date>
  <primary_completion_date type="Actual">October 12, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Global Severity Assessment- Mechanics of Shaving</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>A total of the Patient's Global Assessment of mechanics of shaving based on following scale:&#xD;
How easy is it to… (please rank each phrase from 1 to 4; 1 = very easy, 2 = easy, 3 = difficult, 4 = very difficult)&#xD;
A) get a smooth shave after shaving? __________&#xD;
B) shave stubborn hairs? __________&#xD;
C) shave against the grain with little irritation? __________&#xD;
D) shave with the grain with little irritation? __________&#xD;
E) glide comfortably over your skin with the razor blade?&#xD;
For each subject, the total score could range from 5 -20, with lower numbers indicating better shave mechanics</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>Patient Global Severity Assessment measures itching/burning/stinging on the following scales:1 (no itching/no burning/no stinging at all) to 5 (very severe) the total score could range from 1-5 with the lower scores promoting a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Survey</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>Quality of Life Survey will measure subjects' overall perception. For Shaving Experience, the total score could range from 6-42 with lower scores denoting better outcome measures.&#xD;
For Shaving Frustration, the total score could range from 3-21 with higher scores denoting better outcome measures.&#xD;
For Achieving Results, the total score could range from 3-21 with lower scores denoting better outcome measures.&#xD;
For Skin Feel, the total score could range from 3-21 with lower scores denoting better outcome measures.&#xD;
For Skin-Confidence, the total score could range from 4-28 with lower scores denoting better outcome measures.&#xD;
For Social Interactions, the total score could range from 6-42 with lower scores denoting better outcome measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lesions</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator Global Assessment (IGA)</measure>
    <time_frame>Baseline, 6 weeks</time_frame>
    <description>Investigator Global Assessment (IGA) will measure disease severity using a scale 0 (Clear) - 5 (Very Severe) with the lower score grade denoting better outcome measures.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Pseudofolliculitis Barbae</condition>
  <arm_group>
    <arm_group_label>Gel and Brush</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>shave gel</intervention_name>
    <description>Non marketed pre-shave gel with the following INCI list of ingredients:&#xD;
WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE</description>
    <arm_group_label>Gel and Brush</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brush</intervention_name>
    <description>All subjects randomized to brush will use the brush with each shave</description>
    <arm_group_label>Gel and Brush</arm_group_label>
    <other_name>Oil of Olay cleansing brush</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males with at least a two year history of the symptoms of PFB.&#xD;
&#xD;
          2. Must be age 20-60 years of age (inclusive).&#xD;
&#xD;
          3. Must wet shave using just a prep and blade razor at least 3 or more times per week,&#xD;
             and be willing to continue that regimen during the study.&#xD;
&#xD;
          4. Must have Mild -to moderate PFB based on IGA rating scales. There are no lesion count&#xD;
             inclusion requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of systemic (oral antibiotics) within the last 4 weeks.&#xD;
&#xD;
          2. Use of topical prescriptions (topical clindamycin, topical retinoids, topical&#xD;
             metronidazole, topical sulfacetamide/sulfur, topical adapalene, benzoyl peroxide,&#xD;
             salicylic acid, glycolic acid, retinol,chemical peels) or over-the-counter products&#xD;
             the subject has used for PFB or Hair Growth within the last 2 weeks. Use of oral&#xD;
             retinoids, laser therapy or electrolysis treatments or waxing in beard area in last 12&#xD;
             months.&#xD;
&#xD;
          3. Individuals who do not wet shave with a bladed razor, or who use electric shavers.&#xD;
&#xD;
          4. Subjects must not have used any type of cleansing or shave brush to the face for six&#xD;
             weeks prior to Baseline.&#xD;
&#xD;
          5. Individuals who have removed a beard within last two months.&#xD;
&#xD;
          6. Individuals who have a history of alopecia areata of the face.&#xD;
&#xD;
          7. Confounding dermatological conditions that would, in the opinion of the principal&#xD;
             investigator, preclude participation in this study such as:&#xD;
&#xD;
               -  Immune deficiency disease (HIV positive, AIDS, sarcoidosis)&#xD;
&#xD;
               -  On immunosuppressive drugs (e.g. oral corticosteroids)&#xD;
&#xD;
               -  Autoimmune disease (lupus, scleroderma, diabetes mellitus, vitiligo)&#xD;
&#xD;
               -  Koebnerizing diseases (e.g. psoriasis, lichens planus, (HPV) human papilloma&#xD;
                  virus, facial verruca, molluscum contagiosum)&#xD;
&#xD;
               -  Tuberculosis, Hepatitis B&#xD;
&#xD;
               -  History of Keloids&#xD;
&#xD;
               -  History of Herpes simplex in treated area&#xD;
&#xD;
               -  Bacterial infection of face including abscesses and draining sinuses of facial&#xD;
                  area&#xD;
&#xD;
               -  Cystic Acne, other acne in bearded area which interferes with shaving as well as&#xD;
                  the ability to distinguish PFB lesions from acne&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>les with psuedofolliculitis barbae</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy McMIchael, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences Dept of Dermatology</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <results_first_submitted>April 19, 2017</results_first_submitted>
  <results_first_submitted_qc>April 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 2, 2017</results_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 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>Hair Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Gel and Brush</title>
          <description>The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.&#xD;
shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE&#xD;
Brush: All subjects randomized to brush will use the brush with each shave</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Gel and Brush</title>
          <description>The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.&#xD;
shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE&#xD;
Brush: All subjects randomized to brush will use the brush with each shave</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="29"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Global Severity Assessment- Mechanics of Shaving</title>
        <description>A total of the Patient's Global Assessment of mechanics of shaving based on following scale:&#xD;
How easy is it to… (please rank each phrase from 1 to 4; 1 = very easy, 2 = easy, 3 = difficult, 4 = very difficult)&#xD;
A) get a smooth shave after shaving? __________&#xD;
B) shave stubborn hairs? __________&#xD;
C) shave against the grain with little irritation? __________&#xD;
D) shave with the grain with little irritation? __________&#xD;
E) glide comfortably over your skin with the razor blade?&#xD;
For each subject, the total score could range from 5 -20, with lower numbers indicating better shave mechanics</description>
        <time_frame>Baseline, 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gel and Brush</title>
            <description>The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.&#xD;
shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE&#xD;
Brush: All subjects randomized to brush will use the brush with each shave</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Severity Assessment- Mechanics of Shaving</title>
          <description>A total of the Patient's Global Assessment of mechanics of shaving based on following scale:&#xD;
How easy is it to… (please rank each phrase from 1 to 4; 1 = very easy, 2 = easy, 3 = difficult, 4 = very difficult)&#xD;
A) get a smooth shave after shaving? __________&#xD;
B) shave stubborn hairs? __________&#xD;
C) shave against the grain with little irritation? __________&#xD;
D) shave with the grain with little irritation? __________&#xD;
E) glide comfortably over your skin with the razor blade?&#xD;
For each subject, the total score could range from 5 -20, with lower numbers indicating better shave mechanics</description>
          <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="15"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9" spread="2.6"/>
                    <measurement group_id="O2" value="12.4" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" spread="4.1"/>
                    <measurement group_id="O2" value="9.7" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)</title>
        <description>Patient Global Severity Assessment measures itching/burning/stinging on the following scales:1 (no itching/no burning/no stinging at all) to 5 (very severe) the total score could range from 1-5 with the lower scores promoting a better outcome.</description>
        <time_frame>Baseline, 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gel and Brush</title>
            <description>The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.&#xD;
shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE&#xD;
Brush: All subjects randomized to brush will use the brush with each shave</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)</title>
          <description>Patient Global Severity Assessment measures itching/burning/stinging on the following scales:1 (no itching/no burning/no stinging at all) to 5 (very severe) the total score could range from 1-5 with the lower scores promoting a better outcome.</description>
          <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="15"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.33" spread="1.04"/>
                    <measurement group_id="O2" value="2.64" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.46" spread="0.74"/>
                    <measurement group_id="O2" value="1.85" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Survey</title>
        <description>Quality of Life Survey will measure subjects' overall perception. For Shaving Experience, the total score could range from 6-42 with lower scores denoting better outcome measures.&#xD;
For Shaving Frustration, the total score could range from 3-21 with higher scores denoting better outcome measures.&#xD;
For Achieving Results, the total score could range from 3-21 with lower scores denoting better outcome measures.&#xD;
For Skin Feel, the total score could range from 3-21 with lower scores denoting better outcome measures.&#xD;
For Skin-Confidence, the total score could range from 4-28 with lower scores denoting better outcome measures.&#xD;
For Social Interactions, the total score could range from 6-42 with lower scores denoting better outcome measures.</description>
        <time_frame>Baseline, 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gel and Brush</title>
            <description>The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.&#xD;
shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE&#xD;
Brush: All subjects randomized to brush will use the brush with each shave</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Survey</title>
          <description>Quality of Life Survey will measure subjects' overall perception. For Shaving Experience, the total score could range from 6-42 with lower scores denoting better outcome measures.&#xD;
For Shaving Frustration, the total score could range from 3-21 with higher scores denoting better outcome measures.&#xD;
For Achieving Results, the total score could range from 3-21 with lower scores denoting better outcome measures.&#xD;
For Skin Feel, the total score could range from 3-21 with lower scores denoting better outcome measures.&#xD;
For Skin-Confidence, the total score could range from 4-28 with lower scores denoting better outcome measures.&#xD;
For Social Interactions, the total score could range from 6-42 with lower scores denoting better outcome measures.</description>
          <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="15"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Shaving Experience</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6" spread="10.3"/>
                    <measurement group_id="O2" value="23.5" spread="6.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Shaving Frustrations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" spread="5.38"/>
                    <measurement group_id="O2" value="11.4" spread="2.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Achieving Results</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" spread="4.88"/>
                    <measurement group_id="O2" value="11.4" spread="4.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Skin Feel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.2" spread="4.60"/>
                    <measurement group_id="O2" value="10.7" spread="4.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Skin-Confidence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3" spread="6.49"/>
                    <measurement group_id="O2" value="13.9" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Social Interactions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" spread="8.8"/>
                    <measurement group_id="O2" value="17.8" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 Shaving Experience</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" spread="6.24"/>
                    <measurement group_id="O2" value="20.5" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 Shaving Frustrations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6" spread="4.8"/>
                    <measurement group_id="O2" value="9.9" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 Achieving Results</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="5.1"/>
                    <measurement group_id="O2" value="8.0" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 Skin Feel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="5.0"/>
                    <measurement group_id="O2" value="8.5" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 Self-Confidence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8" spread="6.5"/>
                    <measurement group_id="O2" value="10.3" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 Social Interactions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.9" spread="10.4"/>
                    <measurement group_id="O2" value="13.3" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lesions</title>
        <description>Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation.</description>
        <time_frame>Baseline, 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gel and Brush</title>
            <description>The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.&#xD;
shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE&#xD;
Brush: All subjects randomized to brush will use the brush with each shave</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group</description>
          </group>
        </group_list>
        <measure>
          <title>Lesions</title>
          <description>Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation.</description>
          <units>lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7" spread="24.2"/>
                    <measurement group_id="O2" value="20.3" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" spread="18.5"/>
                    <measurement group_id="O2" value="16.1" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Investigator Global Assessment (IGA)</title>
        <description>Investigator Global Assessment (IGA) will measure disease severity using a scale 0 (Clear) - 5 (Very Severe) with the lower score grade denoting better outcome measures.</description>
        <time_frame>Baseline, 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gel and Brush</title>
            <description>The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.&#xD;
shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE&#xD;
Brush: All subjects randomized to brush will use the brush with each shave</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator Global Assessment (IGA)</title>
          <description>Investigator Global Assessment (IGA) will measure disease severity using a scale 0 (Clear) - 5 (Very Severe) with the lower score grade denoting better outcome measures.</description>
          <units>units 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="15"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.73" spread="0.79"/>
                    <measurement group_id="O2" value="2.57" spread="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.06" spread="1.38"/>
                    <measurement group_id="O2" value="2.26" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Gel and Brush</title>
          <description>The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.&#xD;
shave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE&#xD;
Brush: All subjects randomized to brush will use the brush with each shave</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group</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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Amy McMichael</name_or_title>
      <organization>WakeForest</organization>
      <phone>336-716-3775</phone>
      <email>amcmicha@wakehealth.edu</email>
    </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/NCT03043534
org study id: IRB00034479
nct id: NCT03043534
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This will be a randomized investigator blinded study of 40 men age 20-60 (inclusive) with
      symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects will be
      divided into two groups: the Control group of 20 subjects and the Experimental group of 20
      Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks.

      All subjects will use their normal razors and shave products during the six week study. The
      Experimental group of subjects will also be given the study product Pre-Shave Gel and
      Cleansing Brush.
This will be a randomized investigator blinded study of up to 40 men age 20-60 (inclusive)
      with symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects
      will be divided into two groups: the Control group of 20 subjects and the Experimental group
      of 20 Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks.

      All subjects will use their normal razors and shave products during the six week study. The
      Experimental group of subjects will also be given the study product Pre-Shave Gel and
      Cleansing Brush. The study gel and brush will be used prior to their normal shave
      routine.Quantitative lesion counts will be done by trained clinicians at each visit. Efficacy
      assessments include Investigator Global Assessment (IGA) scoring
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Patient Global Severity Assessment- Mechanics of Shaving
time frame: Baseline, 6 weeks
description: A total of the Patient's Global Assessment of mechanics of shaving based on following scale:
How easy is it to… (please rank each phrase from 1 to 4; 1 = very easy, 2 = easy, 3 = difficult, 4 = very difficult)
A) get a smooth shave after shaving? __________
B) shave stubborn hairs? __________
C) shave against the grain with little irritation? __________
D) shave with the grain with little irritation? __________
E) glide comfortably over your skin with the razor blade?
For each subject, the total score could range from 5 -20, with lower numbers indicating better shave mechanics
measure: Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)
time frame: Baseline, 6 weeks
description: Patient Global Severity Assessment measures itching/burning/stinging on the following scales:1 (no itching/no burning/no stinging at all) to 5 (very severe) the total score could range from 1-5 with the lower scores promoting a better outcome.
measure: Quality of Life Survey
time frame: Baseline, 6 weeks
description: Quality of Life Survey will measure subjects' overall perception. For Shaving Experience, the total score could range from 6-42 with lower scores denoting better outcome measures.
For Shaving Frustration, the total score could range from 3-21 with higher scores denoting better outcome measures.
For Achieving Results, the total score could range from 3-21 with lower scores denoting better outcome measures.
For Skin Feel, the total score could range from 3-21 with lower scores denoting better outcome measures.
For Skin-Confidence, the total score could range from 4-28 with lower scores denoting better outcome measures.
For Social Interactions, the total score could range from 6-42 with lower scores denoting better outcome measures.
measure: Lesions
time frame: Baseline, 6 weeks
description: Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation.
measure: Investigator Global Assessment (IGA)
time frame: Baseline, 6 weeks
description: Investigator Global Assessment (IGA) will measure disease severity using a scale 0 (Clear) - 5 (Very Severe) with the lower score grade denoting better outcome measures.
arm group label: Gel and Brush
arm group type: Experimental
description: The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.
arm group label: Control
arm group type: No Intervention
description: Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group
intervention type: Other
intervention name: shave gel
description: Non marketed pre-shave gel with the following INCI list of ingredients:
WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE
arm group label: Gel and Brush
intervention type: Other
intervention name: Brush
description: All subjects randomized to brush will use the brush with each shave
arm group label: Gel and Brush
other name: Oil of Olay cleansing brush
criteria: 
gender: Male
gender based: Yes
gender description: les with psuedofolliculitis barbae
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Amy McMIchael, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hair Diseases
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 