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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
26
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
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
Skincare Physicians
Chestnut Hill, Massachusetts, United States
Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance
Time frame: Baseline-Week 4
Difference in Keratosis pilaris Investigator Score
Time frame: Baseline-Week 4
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