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

Sponsored by:	Johnson & Johnson Consumer & Personal Products Worldwide
Information provided by:	Johnson & Johnson Consumer & Personal Products Worldwide
ClinicalTrials.gov Identifier:	NCT00714714

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 gel 0.1% Drug: adapalene gel 0.3%	Phase IV

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide Tretinoin Adapalene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment
Official Title:	An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products Using a Split-Face Model

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: Daily, for two weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Instrument measurements, including photography [ Time Frame: Daily, for two weeks ] [ Designated as safety issue: No ]
Incidence and severity of adverse events [ Time Frame: Weekly, for two weeks ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	January 2008
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Tretinoin and Adapalene gels in a split-face model	Drug: tretinoin gel 0.1% tretinoin gel 0.1% topically applied daily in a split-face model for two weeks Drug: adapalene gel 0.3% adapalene gel 0.3% topically applied daily in a split-face model for two weeks
2: Experimental Adapalene and Tretinoin gels in a opposite-side split-face model	Drug: tretinoin gel 0.1% tretinoin gel 0.1% topically applied daily in a split-face model for two weeks Drug: adapalene gel 0.3% adapalene gel 0.3% topically applied daily in a split-face model for two weeks

Detailed Description:

At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products on their faces, each on half face. The side of face receiving each product is randomly assigned. One group will use Retin-A MICRO® Gel Pump 0.1% on the left side and Differin Gel .3% on the right side of the face daily for two 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 two consecutive weeks after washing with the same study-supplied facial wash.

Subjects will return to the study center every weekday morning for evaluation and for the morning application of both study products. Study personnel will monitor application on the weekdays. There will be a daily clinical evaluation of skin irritation by a blinded dermatologist and by subjects. 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 40 Years
Genders Eligible for Study:	Female
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).
Subject 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 study start.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714714

Locations

United States, Pennsylvania
A J&J CPPW Investigational Site
Broomall, Pennsylvania, United States, 19008

Sponsors and Collaborators

Johnson & Johnson Consumer & Personal Products Worldwide

Investigators

Study Director:

Ana B Rossi, MD

Johnson & Johnson Consumer & Personal Products Companies, Inc.

More Information

Responsible Party:	J&J CPPW ( Joyce L. Hauze, MBA, CCRA )
Study ID Numbers:	CA-P-5893
Study First Received:	July 10, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00714714
Health Authority:	United States: Institutional Review Board

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

acne
irritation
objective sensory methods

Study placed in the following topic categories:

Exanthema
Facial Dermatoses
Skin Diseases
Facies
Benzoyl Peroxide

Tretinoin
Adapalene
Sebaceous Gland Diseases
Acne Vulgaris

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Keratolytic Agents
Acneiform Eruptions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009