Keratosis Pilaris Clinical Trial
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
Verified date | August 2017 |
Source | AOBiome LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | September 3, 2016 |
Est. primary completion date | June 8, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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, a-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) |
Country | Name | City | State |
---|---|---|---|
United States | Skincare Physicians | Chestnut Hill | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
AOBiome LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Difference in Skindex16 Quality of Life survey | Baseline-Week 4 | ||
Primary | Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance | Baseline-Week 4 | ||
Secondary | Difference in Keratosis pilaris Investigator Score | Baseline-Week 4 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05666011 -
Laser to Aid in Treatment of Keratosis Pilaris on Arms
|
N/A | |
Completed |
NCT04797663 -
Long-pulsed 1064 nm Nd-YAG Laser Versus TCA 20% in Treatment of Keratosis Pilaris
|
Phase 4 | |
Terminated |
NCT00944216 -
Efficacy and Safety of Salkera Emollient Foam in the Treatment of Moderate to Severe Keratosis Pilaris, a Prospective Study
|
Phase 4 | |
Active, not recruiting |
NCT06032078 -
Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis Pilaris
|
N/A | |
Recruiting |
NCT05535517 -
Development and Validation of an Investigator Global Assessment Score for Keratosis Pilaris
|