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

NCT ID: NCT01313728

Last Updated: 2012-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-01-31

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Dapsone plus Tretinoin Gel

Intervention Type: DRUG

Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks

Tretinoin Gel Alone

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

Group Type: ACTIVE_COMPARATOR

Tretinoin Gel

Intervention Type: DRUG

Tretinoin gel applied once daily to the assigned side of the face for 2 weeks

Interventions

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

Intervention Type: DRUG

Tretinoin Gel

Tretinoin gel applied once daily to the assigned side of the face for 2 weeks

Intervention Type: DRUG

Other Intervention Names

Aczone Gel 5% plus Retin-A Micro Gel 0.1% Pump; Retin-A Micro Gel 0.1% Pump

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Lineberry

Role: STUDY_DIRECTOR

Bausch Health Americas, Inc.

Locations

Skin Study Center

Broomall, Pennsylvania, United States

Countries

United States

Related Links

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

FDA's Drug Finder

Other Identifiers

CA-P-7966

Identifier Type: -

Identifier Source: org_study_id