NCT03243617

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: AOBiome LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Keratosis Pilaris

Interventions

Type	Name	Description
OTHER	Placebo	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
OTHER	AO+Mist	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

Timeline

• Start date: 2015-12-04
• Primary completion: 2016-06-08
• Completion: 2016-09-03
• First posted: 2017-08-09
• Last updated: 2017-08-09

Locations

1 site across 1 country: United States