Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face

NCT ID: NCT00919191

Last Updated: 2012-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-05-31

Brief Summary

A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers.

Detailed Description

At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products to their faces, each on one side only. The side of the face receiving each product is randomly assigned. One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.

Subjects will return to the study center every weekday morning for evaluation and application of both study products. Applications done on the weekends, will be done at home by the subject. At each visit the subject will be scored for cutaneous treatment effects by a blinded evaluator. At baseline and at the end of each week, subjects will be photographed and have chromometer readings.

Conditions

Acne Vulgaris

Study Design

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

Study Groups

Two interventions in split-face model

Once daily use in a split face model:

1. Tretinoin gel

2. Adapalene Benzoyl peroxide

Group Type: EXPERIMENTAL

Tretinoin gel

Intervention Type: DRUG

Tretinoin gel 0.04% used once daily in a split-face model

Adapalene and Benzoyl peroxide

Intervention Type: DRUG

Adapalene .1% and Benzoyl peroxide 2.5%

Interventions

Tretinoin gel

Tretinoin gel 0.04% used once daily in a split-face model

Intervention Type: DRUG

Adapalene and Benzoyl peroxide

Adapalene .1% and Benzoyl peroxide 2.5%

Intervention Type: DRUG

Other Intervention Names

Retin-A Micro Gel 0.04% Pump; Epiduo Gel

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers
• Before screening, subjects (or legally authorized representative) must read and sign the IRB approved Informed Consent Form (includes HIPPA and Photo release)
• Subjects must have Fitzpatrick Skin Type I, II or III, and judged by the Investigator to have healthy skin
• Subject's bilateral facial skin must be clear of any confounding irritation, rashes, acne, rosacea, etc. prior to the study
• Subject must be free of systemic retinoids for at least 2 months
• Subject must not be using any topical retinoids, systemic antibiotics, nicotinamide or systemic steroids for 1 month prior to study start
• All other topical medications to face (e.g., steroids, antimicrobials, salicylic acid and benzoyl peroxide) and cosmetics containing retinols, AHA's and bleaching agents such as hydroquinone are to be discontinued at least 2 weeks prior to study initiation
• Subjects will not apply any emollients and cosmetics to the facial area 24 hours prior to study initiation
• Subject must not be planning to become pregnant or nursing before entering the study and during the study period. In addition if using birth control pills, subject must be stabilized for at least 2 months. If subject is of child bearing potential, subject must be using approved method of birth control. Approved methods are birth control pills, implants, patches or spermicide with condoms.

Exclusion Criteria

• Subjects who are pregnant or nursing
• Subjects who have a grade 1 or more for facial erythema
• Subjects who exhibit any skin condition (i.e., atopic dermatitis, seborrheic dermatitis, and psoriasis) or disease that may require concurrent therapy or may confound the evaluation of drug safety or efficacy
• Subjects who have a history of hypersensitivity to any of the formulation components listed in Appendix 1.
• Subjects who have received any experimental drug or used any experimental device 30 days prior to initiation of study therapy
• Subjects who have excessive facial hair that may obstruct or hinder the evaluation of any reactions
• Subjects who use any known photosensitizing agents
• Subjects who presently have skin cancer or actinic keratosis on the face

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

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Rossi, MD

Role: STUDY_DIRECTOR

Johnson & Johnson Consumer and Personal Products Worldwide

Locations

Skin Study Center

Broomall, Pennsylvania, United States

Countries

United States

References

Leyden JJ, Nighland M, Rossi AB, Ramaswamy R. Irritation potential of tretinoin gel microsphere pump versus adapalene plus benzoyl peroxide gel. J Drugs Dermatol. 2010 Aug;9(8):998-1003.

Reference Type: RESULT

PMID: 20684151 (View on PubMed)

Related Links

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

FDA's Drug Finder

Other Identifiers

CA-P-6805

Identifier Type: -

Identifier Source: org_study_id