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

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ClinicalTrials.gov Identifier: NCT00919191
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : March 10, 2010
Last Update Posted : February 15, 2012
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Tracking Information
First Submitted Date  ICMJE June 10, 2009
First Posted Date  ICMJE June 12, 2009
Results First Submitted Date  ICMJE December 28, 2009
Results First Posted Date  ICMJE March 10, 2010
Last Update Posted Date February 15, 2012
Study Start Date  ICMJE April 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2010)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
Comparative Assessment of Facial Irritation and Cutaneous Effects. [ Time Frame: Daily, for 3 weeks ]
Change History Complete list of historical versions of study NCT00919191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2010)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face
Official Title  ICMJE An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products Using A Split-Face Model
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Two interventions in split-face model

Once daily use in a split face model:

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2010)
26
Original Actual Enrollment  ICMJE
 (submitted: June 11, 2009)
24
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00919191
Other Study ID Numbers  ICMJE CA-P-6805
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch Health Americas, Inc.
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ana Rossi, MD Johnson & Johnson Consumer and Personal Products Worldwide
PRS Account Bausch Health Americas, Inc.
Verification Date February 2012

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