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

Sponsor:	Johnson & Johnson Consumer & Personal Products Worldwide
Information provided by:	Johnson & Johnson Consumer & Personal Products Worldwide
ClinicalTrials.gov Identifier:	NCT00952523

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 and adapalene-benzoyl peroxide facial gels	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Single Group Assignment
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:

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide Adapalene Tretinoin

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Consumer & Personal Products Worldwide:

Primary Outcome Measures:

Comparative assessment of facial irritation and cutaneous effects [ Time Frame: Cumulative scores, recorded each weekday for three weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Photographic Chromometer Readings [ Time Frame: Baseline, end of Weeks 1, 2, and 3 ] [ Designated as safety issue: No ]

Enrollment:	170
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
Tretinoin & Adapalene-Benzoyl Peroxide: Experimental Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model	Drug: tretinoin and adapalene-benzoyl peroxide facial gels A marketed facial gel containing Tretinoin 0.04% is applied to one side of the face and another marketed facial gel containing Adapalene .1% and Benzoyl peroxide 2.5% is applied to the other side of the face daily for three weeks.

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

Johnson & Johnson Consumer & Personal Products Worldwide

Investigators

Study Director:

Ana Rossi, MD

Johnson & Johnson Consumer & Personal Products Worldwide

More Information

No publications provided

Responsible Party:	Johnson & Johnson Consumer and Personal Products Worldwide ( Joyce L Hauze, Sr. Project Manager, Clinical Operations )
Study ID Numbers:	CA-P-7190
Study First Received:	August 4, 2009
Last Updated:	December 15, 2009
ClinicalTrials.gov Identifier:	NCT00952523 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johnson & Johnson Consumer & Personal Products Worldwide:

acne
irritation
objective sensory methods

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Facial Dermatoses
Skin Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Benzoyl Peroxide
Sebaceous Gland Diseases
Adapalene
Acne Vulgaris
Pharmacologic Actions
Keratolytic Agents

Sensory System Agents
Analgesics, Non-Narcotic
Acneiform Eruptions
Therapeutic Uses
Tretinoin
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 08, 2010