CompletedNot Applicable

Cosmetic Study of AO+Mist in Improving the Appearance of Skin Afflicted With Keratosis Pilaris

United States26 participantsStarted 2015-12-04

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male and female subjects ≥18 and ≤65 years of age
✓. Subject is in good general health
✓. Diagnosis of keratosis pilaris involving areas of the body affected bilaterally
✓. Subject has Fitzpatrick Skin Type I-VI
✓. Willing to refrain from using any treatments, other than the investigational product, including antibiotics, for acne present on the face.
✓. Ability to comprehend and comply with procedures
✓. Agree to commit to participate in the current protocol
✓. 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

✕. Male and female subjects under 18 years or over 65 years of age
✕. Female subjects who are pregnant or lactating
✕. Subjects who have received laser therapy to the KP affected area in the past 1 year
✕. Subjects with a concurrent diagnosis of another skin condition or malignancy
✕. Subjects with tan or sunburn over the area affected by KPin the past month
✕. Subjects with open, non-healing sores or infections at any skin site
✕. 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.
✕. Treatment with systemic corticosteroids (including intranasal and inhaled corticosteroids) within 4 weeks prior to baseline

What they're measuring

Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance

Timeframe: Baseline-Week 4

Trial details

NCT IDNCT03243617

SponsorAOBiome LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-06-08

View on ClinicalTrials.gov More Keratosis Pilaris trials