Evaluation of Irritation That Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face.
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.
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 tretinoin facial gel on the left side and adapalene facial gel 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.
Study Design
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Conditions
Acne Vulgaris
Intervention
Adapalene Gel, Tretinoin Gel
Location
A J&J CPPW Investigational Site
Broomall
Pennsylvania
United States
19008
Status
Completed
Source
Johnson & Johnson Consumer & Personal Products Worldwide
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00714714
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Tretinoin
An important regulator of GENE EXPRESSION during growth and development, and in NEOPLASMS. Tretinoin, also known as retinoic acid and derived from maternal VITAMIN A, is essential for normal GROWTH; and EMBRYONIC DEVELOPMENT. An excess of tretinoin can be teratogenic. It is used in the treatment of PSORIASIS; ACNE VULGARIS; and several other SKIN DISEASES. It has also been approved for use in promyelocytic leukemia (LEUKEMIA, PROMYELOCYTIC, ACUTE).
Isotretinoin
A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.
Acne Vulgaris
A chronic disorder of the pilosebaceous apparatus associated with an increase in sebum secretion. It is characterized by open comedones (blackheads), closed comedones (whiteheads), and pustular nodules. The cause is unknown, but heredity and age are predisposing factors.
Acneiform Eruptions
Visible efflorescent lesions of the skin caused by acne or resembling acne. (Dorland, 28th ed, p18, 575)
Desmoglein 3
A desmosomal cadherin that is an autoantigen in the acquired skin disorder PEMPHIGUS VULGARIS.
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