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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AO+Mist | Active Comparator | Cosmetic Product AO+Mist |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Subjects are instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance | Baseline-Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Keratosis pilaris Investigator Score | Baseline-Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Skindex16 Quality of Life survey | Baseline-Week 4 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Dover, MD | Skincare Physicians | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skincare Physicians | Chestnut Hill | Massachusetts | 02467 | United States |
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| ID | Term |
|---|---|
| C537412 | Burnett Schwartz Berberian syndrome |
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Bi-Lateral study
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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.
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| AO+Mist | Other | Subjects are instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:
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