Clinical trial NCT03243617: Cosmetic Study of AO+Mist in Improving the Appearance of Skin Afflicted With Keratosis Pilaris
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratosis Pilaris
Lead sponsor: AOBiome LLC
Sponsor class: INDUSTRY
First posted: 2017-08-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Bi-Lateral study
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Male and female subjects ≥18 and ≤65 years of age
2. Subject is in good general health
3. Diagnosis of keratosis pilaris involving areas of the body affected bilaterally
4. Subject has Fitzpatrick Skin Type I-VI
5. Willing to refrain from using any treatments, other than the investigational product, including antibiotics, for acne present on the face.
6. Ability to comprehend and comply with procedures
7. Agree to commit to participate in the current protocol
8. Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read)

Exclusion Criteria:

1. Male and female subjects under 18 years or over 65 years of age
2. Female subjects who are pregnant or lactating
3. Subjects who have received laser therapy to the KP affected area in the past 1 year
4. Subjects with a concurrent diagnosis of another skin condition or malignancy
5. Subjects with tan or sunburn over the area affected by KPin the past month
6. Subjects with open, non-healing sores or infections at any skin site
7. Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid, including lactic acid lotions (Am-Lactin, Lac-Hydrin), urea cream (Carmol 10, Carmol 20, Carmol 40, Urix 40), salicylic acid (Salex lotion), topical corticosteroids within 4 weeks prior to baseline.
8. Treatment with systemic corticosteroids (including intranasal and inhaled corticosteroids) within 4 weeks prior to baseline
9. Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 4 weeks prior to baseline
10. Prescription topical retinoid use on the face or body within 4 weeks of baseline (e.g., tretinoin, tazarotene, adapalene).
11. Oral retinoid use (e.g., isotretinoin) within 12 months prior to baseline or vitamin A supplements greater than 10,000 units/day within 6 months of baseline..
12. Treatment with any investigational drug within 30 days prior to the beginning of the screening period (this includes investigational formulations of marketed products, inhaled and topical drugs)
13. Subjects who are unable to understand the protocol or give informed consent
14. Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance
timeFrame: Baseline-Week 4
Secondary outcomes:
measure: Difference in Keratosis pilaris Investigator Score
timeFrame: Baseline-Week 4
Other outcomes:
measure: Difference in Skindex16 Quality of Life survey
timeFrame: Baseline-Week 4
Locations:
city: Chestnut Hill
country: United States
facility: Skincare Physicians
state: Massachusetts
Study officials:
affiliation: Skincare Physicians
name: Jeffrey Dover, MD
role: PRINCIPAL_INVESTIGATOR
References: