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

An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products Using A Split-Face Model

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Tretinoin gel; Drug: Adapalene and Benzoyl peroxide

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • Skin Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Two interventions in split-face model; Once daily use in a split face model: Tretinoin gel; Adapalene Benzoyl peroxide	Drug: Tretinoin gel; Tretinoin gel 0.04% used once daily in a split-face model; Other Names: Retin-A Micro Gel 0.04% Pump; Drug: Adapalene and Benzoyl peroxide; Adapalene .1% and Benzoyl peroxide 2.5%; Other Names: Epiduo Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparative Assessment of Facial Irritation and Cutaneous Effects.	Expert Grader Assessment, including cumulative scores for Erythema and Dryness on a scale of 0=none to 8=severe	Daily, for 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self Assessment of Burning/Stinging and Itching	Cumulative scores of Subjects' self assessment of burning/stinging and itching on a score from 0=none to 3=severe	Daily, for 3 weeks

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: Ana Rossi, MD, Johnson & Johnson Consumer and Personal Products Worldwide

Publications and helpful links

General Publications

• 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.

Helpful Links

• FDA's Drug Finder

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: June 10, 2009
• First Submitted That Met QC Criteria: June 11, 2009
• First Posted (Estimate): June 12, 2009

Study Record Updates

• Last Update Posted (Estimate): February 15, 2012
• Last Update Submitted That Met QC Criteria: February 14, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: acne; irritation; objective sensory methods
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Dermatologic Agents; Keratolytic Agents; Benzoyl Peroxide; Tretinoin; Adapalene
• Other Study ID Numbers: CA-P-6805

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No