NCT01313728

A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products

An Investigator-Blind, Phase 4 Study Assessing Mitigation of Facial Irritation When Comparing the Use of Two Acne Treatment Products (Retin-A Micro® 0.1 % Pump and Aczone®) With One Treatment Product (Retin-A Micro® 0.1 % Pump) Using a Split-Face Model

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study is to see if there's any difference in the amount of facial irritation when two acne products are used together on one side of the face, compared to one acne treatment product used alone on the other side of the face. All people participating in this trial will be required to return to the same study center every weekday for two weeks for the investigator to check for irritation on the face and to have the products applied - on weekends they will have to put them on at home. If one side of the face is more irritated than the other side, a picture will be taken as well.

Detailed description

This is an investigator-blind, randomized, balanced study comparing two treatment regimens in a split-face model. All subjects will apply Retin-A Micro Gel (tretinoin) 0.1 % Pump, and Aczone Gel (dapsone) 5% daily to one side of the face (with 1 hour between applications, applying Aczone Gel first) and Retin-A Micro Gel 0.1 % Pump to the other side of the face in a randomized scheme for two consecutive weeks. Subjects will return to the study center daily for evaluation and for application of both products (weekend applications will be done at home). At each visit the subject will be evaluated and scored for irritation and cutaneous treatment effects. Subjects presenting with differences in irritation between one side of the face and the other will be photographed and have chromometer readings taken. A single treatment center is expected to enroll at least 24 subjects.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Dapsone plus Tretinoin Gel	Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks
DRUG	Tretinoin Gel	Tretinoin gel applied once daily to the assigned side of the face for 2 weeks

Timeline

• Start date: 2010-12-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2011-03-14
• Last updated: 2012-02-15
• Results posted: 2012-01-19

Locations

1 site across 1 country: United States