<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/NCT03243617</url>
  </required_header>
  <id_info>
    <org_study_id>AOB2015-02</org_study_id>
    <nct_id>NCT03243617</nct_id>
  </id_info>
  <brief_title>Cosmetic Study of AO+Mist in Improving the Appearance of Skin Afflicted With Keratosis Pilaris</brief_title>
  <official_title>A Placebo-Controlled, Double-Blind, Bi-Lateral Study to Evaluate the Performance and Tolerability of a Cosmetic Product Designed to Improve the Appearance of Skin Afflicted With Keratosis Pilaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AOBiome LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AOBiome LLC</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>
      The purpose of this study is to demonstrate the safety, tolerability and efficacy of AO+ Mist&#xD;
      administered daily for 4 weeks to improve the appearance of skin afflicted with keratosis&#xD;
      pilaris.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single center, double-blind, placebo-controlled study in subjects with&#xD;
      keratosis pilaris affecting both sides of the body.&#xD;
&#xD;
      Subjects will be screened within 4 weeks of enrollment. Subjects will be seen at the research&#xD;
      facility on for the baseline visit and will be asked to return to the site on weeks 1, 2, 3&#xD;
      and 4 for assessments. Test product application will occur for four weeks starting with the&#xD;
      day of the baseline visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2015</start_date>
  <completion_date type="Actual">September 3, 2016</completion_date>
  <primary_completion_date type="Actual">June 8, 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>
    <intervention_model_description>Bi-Lateral study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>AO+ Mist (or placebo) are supplied in white 100mL metered spray bottles. Test products are blinded and labeled for application to the LEFT or RIGHT side of the body.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance</measure>
    <time_frame>Baseline-Week 4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in Keratosis pilaris Investigator Score</measure>
    <time_frame>Baseline-Week 4</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Difference in Skindex16 Quality of Life survey</measure>
    <time_frame>Baseline-Week 4</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Keratosis Pilaris</condition>
  <arm_group>
    <arm_group_label>AO+Mist</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cosmetic Product AO+Mist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects are instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:&#xD;
LEFT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: LEFT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.&#xD;
RIGHT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: RIGHT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.&#xD;
Subjects may not wash their body with soap and water AFTER the applications</description>
    <arm_group_label>AO+Mist</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AO+Mist</intervention_name>
    <description>Subjects are instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:&#xD;
LEFT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: LEFT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.&#xD;
RIGHT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: RIGHT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.&#xD;
Subjects may not wash their body with soap and water AFTER the applications</description>
    <arm_group_label>AO+Mist</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects ≥18 and ≤65 years of age&#xD;
&#xD;
          2. Subject is in good general health&#xD;
&#xD;
          3. Diagnosis of keratosis pilaris involving areas of the body affected bilaterally&#xD;
&#xD;
          4. Subject has Fitzpatrick Skin Type I-VI&#xD;
&#xD;
          5. Willing to refrain from using any treatments, other than the investigational product,&#xD;
             including antibiotics, for acne present on the face.&#xD;
&#xD;
          6. Ability to comprehend and comply with procedures&#xD;
&#xD;
          7. Agree to commit to participate in the current protocol&#xD;
&#xD;
          8. Provide written informed consent prior to any study procedure being performed (all&#xD;
             subjects should be able to understand the informed consent form and any other&#xD;
             documents that subjects are required to read)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects under 18 years or over 65 years of age&#xD;
&#xD;
          2. Female subjects who are pregnant or lactating&#xD;
&#xD;
          3. Subjects who have received laser therapy to the KP affected area in the past 1 year&#xD;
&#xD;
          4. Subjects with a concurrent diagnosis of another skin condition or malignancy&#xD;
&#xD;
          5. Subjects with tan or sunburn over the area affected by KPin the past month&#xD;
&#xD;
          6. Subjects with open, non-healing sores or infections at any skin site&#xD;
&#xD;
          7. Treatment with over-the-counter topical medications for the treatment of acne vulgaris&#xD;
             including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids,&#xD;
             α-hydroxy/glycolic acid, including lactic acid lotions (Am-Lactin, Lac-Hydrin), urea&#xD;
             cream (Carmol 10, Carmol 20, Carmol 40, Urix 40), salicylic acid (Salex lotion),&#xD;
             topical corticosteroids within 4 weeks prior to baseline.&#xD;
&#xD;
          8. Treatment with systemic corticosteroids (including intranasal and inhaled&#xD;
             corticosteroids) within 4 weeks prior to baseline&#xD;
&#xD;
          9. Treatment with systemic antibiotics or systemic anti-acne drugs or systemic&#xD;
             anti-inflammatory drugs within 4 weeks prior to baseline&#xD;
&#xD;
         10. Prescription topical retinoid use on the face or body within 4 weeks of baseline&#xD;
             (e.g., tretinoin, tazarotene, adapalene).&#xD;
&#xD;
         11. Oral retinoid use (e.g., isotretinoin) within 12 months prior to baseline or vitamin A&#xD;
             supplements greater than 10,000 units/day within 6 months of baseline..&#xD;
&#xD;
         12. Treatment with any investigational drug within 30 days prior to the beginning of the&#xD;
             screening period (this includes investigational formulations of marketed products,&#xD;
             inhaled and topical drugs)&#xD;
&#xD;
         13. Subjects who are unable to understand the protocol or give informed consent&#xD;
&#xD;
         14. Any other condition and/or situation that causes the Investigator to deem a subject&#xD;
             unsuitable for the study (e.g., due to expected study medication non-compliance,&#xD;
             inability to medically tolerate the study procedures, or a subject's unwillingness to&#xD;
             comply with study-related procedures)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Dover, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Skincare Physicians</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Skincare Physicians</name>
      <address>
        <city>Chestnut Hill</city>
        <state>Massachusetts</state>
        <zip>02467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</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>Keratosis, Actinic</mesh_term>
    <mesh_term>Abnormalities, Multiple</mesh_term>
    <mesh_term>Darier Disease</mesh_term>
    <mesh_term>Keratosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03243617
org study id: AOB2015-02
nct id: NCT03243617
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to demonstrate the safety, tolerability and efficacy of AO+ Mist
      administered daily for 4 weeks to improve the appearance of skin afflicted with keratosis
      pilaris.
This will be a single center, double-blind, placebo-controlled study in subjects with
      keratosis pilaris affecting both sides of the body.

      Subjects will be screened within 4 weeks of enrollment. Subjects will be seen at the research
      facility on for the baseline visit and will be asked to return to the site on weeks 1, 2, 3
      and 4 for assessments. Test product application will occur for four weeks starting with the
      day of the baseline visit.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Bi-Lateral study
primary purpose: Other
masking: Double (Participant, Care Provider)
masking description: AO+ Mist (or placebo) are supplied in white 100mL metered spray bottles. Test products are blinded and labeled for application to the LEFT or RIGHT side of the body.
measure: Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance
time frame: Baseline-Week 4
measure: Difference in Keratosis pilaris Investigator Score
time frame: Baseline-Week 4
measure: Difference in Skindex16 Quality of Life survey
time frame: Baseline-Week 4
arm group label: AO+Mist
arm group type: Active Comparator
description: Cosmetic Product AO+Mist
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Other
intervention name: Placebo
description: Subjects are instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:
LEFT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: LEFT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
RIGHT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: RIGHT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
Subjects may not wash their body with soap and water AFTER the applications
arm group label: AO+Mist
arm group label: Placebo
intervention type: Other
intervention name: AO+Mist
description: Subjects are instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:
LEFT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: LEFT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
RIGHT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: RIGHT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
Subjects may not wash their body with soap and water AFTER the applications
arm group label: AO+Mist
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jeffrey Dover, MD
role: Principal Investigator
affiliation: Skincare Physicians
facility: 
country: United States
responsible party type: Sponsor
mesh term: Keratosis, Actinic
mesh term: Abnormalities, Multiple
mesh term: Darier Disease
mesh term: Keratosis
sharing ipd: No