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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00919191
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : March 10, 2010
Last Update Posted : February 15, 2012
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

June 10, 2009
June 12, 2009
December 28, 2009
March 10, 2010
February 15, 2012
April 2009
May 2009   (Final data collection date for primary outcome measure)
Comparative Assessment of Facial Irritation and Cutaneous Effects. [ Time Frame: Daily, for 3 weeks ]
Expert Grader Assessment, including cumulative scores for Erythema and Dryness on a scale of 0=none to 8=severe
Comparative Assessment of Facial Irritation and Cutaneous Effects. [ Time Frame: Daily, for 3 weeks ]
Complete list of historical versions of study NCT00919191 on Archive Site
Self Assessment of Burning/Stinging and Itching [ Time Frame: Daily, for 3 weeks ]
Cumulative scores of Subjects' self assessment of burning/stinging and itching on a score from 0=none to 3=severe
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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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Acne Vulgaris
  • Drug: Tretinoin gel
    Tretinoin gel 0.04% used once daily in a split-face model
    Other Name: Retin-A Micro Gel 0.04% Pump
  • Drug: Adapalene and Benzoyl peroxide
    Adapalene .1% and Benzoyl peroxide 2.5%
    Other Name: Epiduo Gel
Experimental: Two interventions in split-face model

Once daily use in a split face model:

  1. Tretinoin gel
  2. Adapalene Benzoyl peroxide
  • Drug: Tretinoin gel
  • Drug: Adapalene and Benzoyl peroxide
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2009
May 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc.
Not Provided
Study Director: Ana Rossi, MD Johnson & Johnson Consumer and Personal Products Worldwide
Valeant Pharmaceuticals International, Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP