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

Condition(s) targeted: Acne Vulgaris

Intervention: Dapsone plus Tretinoin Gel (Drug); Tretinoin Gel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Valeant Pharmaceuticals International, Inc.

Official(s) and/or principal investigator(s):
David Lineberry, Study Director, Affiliation: Valeant Pharmaceuticals International, Inc.

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.

Official title: 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

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome:

Expert Grader Assessment - Erythema

Expert Grader Assessment - Dryness

Secondary outcome:

Subject Assessment - Burning/Stinging

Subject Assessment - Itching

Subject Assessment - Tightness

Facial Tolerance

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.

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Fitzpatrick Skin Type I, II or III with healthy skin as judged by the investigator

- Bilateral skin is clear of any confounding irritation, rashes, acne, rosacea, etc.,

prior to study start

- Subjects are willing to avoid applying emollients or cosmetics to the face 24 hours

before they start, and during the study

- If subject is of childbearing potential, subject has been using a protocol-approved

method of birth control for a certain amount of time, and is willing to continue using it throughout the study Exclusion Criteria:

- Subjects who are pregnant or nursing, or intend to be during the study

- Subjects with any condition or medical history, or using any drug or medication, that

might negatively affect the subject's safety or the validity of study results, either as listed in the protocol or in the opinion of the investigator

- Subjects who have facial hair that may obstruct or hinder the evaluation of any

reactions

- Subjects who use any known photosensitizing agents

Skin Study Center, Broomall, Pennsylvania 19008, United States

FDA's Drug Finder

Starting date: December 2010
Last updated: February 14, 2012