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

Phase 4

Completed

Conditions: Acne Vulgaris

Interventions: Drug: Dapsone plus Tretinoin Gel
Drug: Tretinoin Gel

Registration Number: NCT01313728

Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 26

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dapsone plus Tretinoin Gel	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 - all subjects participate in both arms in a split-face model
Tretinoin Gel Alone	Tretinoin Gel	Tretinoin gel applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model

Primary Outcome Measures

Name	Time	Method
Expert Grader Assessment - Erythema	Baseline to 2 Weeks	Ordinal erythema scores (on a scale of 0=none to 8=severe scaling and fissuring) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).
Expert Grader Assessment - Dryness	Baseline to 2 Weeks	Ordinal dryness scores (on a scale of 0=none to 8=deep) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).

Secondary Outcome Measures

Name	Time	Method
Subject Assessment - Burning/Stinging	Baseline to 2 Weeks	Ordinal burning/stinging scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).
Subject Assessment - Itching	Baseline to 2 Weeks	Ordinal itching scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).
Subject Assessment - Tightness	Baseline to 2 Weeks	Ordinal tightness scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).
Facial Tolerance	Baseline to 2 Weeks	All interval measurements were combined for comparative assessment between treatment regimens. Facial tolerance is the sum of scores from Erythema, Dryness, Burning/Stinging, Itching, and Tightness assessments, reported in Outcome Measures 1-5. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 6250 (highest possible combined score of 25, times 10 days, times 25 subjects).