Evaluation of Irritation That Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face.
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|ClinicalTrials.gov Identifier: NCT00714714|
Recruitment Status : Completed
First Posted : July 14, 2008
Results First Posted : September 2, 2009
Last Update Posted : February 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Adapalene Gel Drug: Tretinoin Gel||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products Using a Split-Face Model|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
Experimental: Tretinoin and Adapalene gels
Adapalene facial gel and tretinoin facial gel applied daily for two weeks on opposite sides of the face (in a split-face model)
Drug: Adapalene Gel
adapalene gel 0.3% topically applied daily in a split-face model for two weeks
Other Name: Differin Gel .3%
Drug: Tretinoin Gel
Tretinoin 0.1% topically applied daily in a split face model for two weeks
Other Name: Retin-A MICRO Gel
- Assessment of Facial Irritation and Cutaneous Effects [ Time Frame: cumulative daily weekday scores for two weeks ]Cumulative daily weekday scores for two weeks on Expert Grader Assessments: Dryness (0-8, none-deep)and Erythema (0-8, none-severe) and Self-Assessments: Burning/Stinging (0-3, none-severe) and Itching (0-3, none-severe)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00714714
|United States, Pennsylvania|
|A J&J CPPW Investigational Site|
|Broomall, Pennsylvania, United States, 19008|
|Study Director:||Ana B Rossi, MD||Johnson & Johnson Consumer & Personal Products Companies, Inc.|