Evaluation of Irritation That Potentially Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face

• ClinicalTrials.gov Identifier: NCT00952523
• Recruitment Status: Completed
• First Posted: August 6, 2009
• Results First Posted: April 9, 2010
• Last Update Posted: February 15, 2012
• Sponsor: Bausch Health Americas, Inc.
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: Tretinoin Facial Gel; Drug: Adapalene/Benzoyl Peroxide Facial Gel	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 162 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products (Retin-A Micro Gel, 0.04% Pump and Epiduo Gel) Using a Split-Face Model
• Study Start Date: July 2009
• Actual Primary Completion Date: October 2009
• Actual Study Completion Date: October 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Tretinoin & Adapalene-Benzoyl Peroxide; Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model	Drug: Tretinoin Facial Gel; A marketed facial gel containing Tretinoin 0.04% is applied to one side of the face daily for three weeks.; Other Name: Retin-A Micro Gel 0.04% Pump; Drug: Adapalene/Benzoyl Peroxide Facial Gel; A marketed facial gel containing Adapalene .1% and Benzoyl peroxide 2.5% is applied to the other side of the face daily for three weeks; Other Name: Epiduo Gel

Outcome Measures

Primary Outcome Measures :

1. Facial Irritation and Cutaneous Effects [ Time Frame: three weeks ]
   Scores on a scale were recorded each weekday. The scale for Erythema and Dryness was from 0=none to 8=severe (highest possible score is calculated as 8x5daysx3weeks=120). The scale for Burning/Stinging and Itching was from 0=none to 3=severe (highest possible score was calculated as 3x5daysx3weeks=45). The scores that were accumulated through the study for each treatment were then compared.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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
• 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

Contacts and Locations

Locations

United States, Pennsylvania

Skin Study Center

Broomall, Pennsylvania, United States, 19008

Sponsors and Collaborators

Bausch Health Americas, Inc.

Investigators

• Study Director: David Lineberry; Bausch Health Americas, Inc.

More Information

Additional Information:

FDA's Drug Finder 

Publications of Results:

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.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT00952523
• Other Study ID Numbers: CA-P-7190
• First Posted: August 6, 2009
• Results First Posted: April 9, 2010
• Last Update Posted: February 15, 2012
• Last Verified: February 2012

Keywords provided by Bausch Health Americas, Inc.:

acne; irritation; objective sensory methods

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Tretinoin; Benzoyl Peroxide; Dermatologic Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Keratolytic Agents