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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00952523
First received: August 4, 2009
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Acne Vulgaris
Drug: Tretinoin Facial Gel
Drug: Adapalene/Benzoyl Peroxide Facial Gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • Facial Irritation and Cutaneous Effects [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 162
Study Start Date: July 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952523

Locations
United States, Pennsylvania
Skin Study Center
Broomall, Pennsylvania, United States, 19008
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: David Lineberry Valeant Pharmaceuticals International, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00952523     History of Changes
Other Study ID Numbers: CA-P-7190
Study First Received: August 4, 2009
Results First Received: January 26, 2010
Last Updated: February 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Valeant Pharmaceuticals International, Inc.:
acne
irritation
objective sensory methods

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Benzoyl Peroxide
Tretinoin
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Keratolytic 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
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 21, 2014