The Effect Of A Controlled Daily Skin Care Regimen On Retinoic Acid Tolerance
Drug: Dove Mild Cleanser
Drug: Dove Facial Moisturizer
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Single-Blind Study to Assess Benefits of a Controlled Daily Skin Care Regimen on Retinoid Intolerant Patients (Derm 570)|
- Retinoid irritation symptoms [ Time Frame: Weeks 6, 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]
- Improvement of sun-damage (wrinkling, uneven skin color, roughness and brown spots). [ Time Frame: At the end of the study (week 24) ] [ Designated as safety issue: No ]
- Treatment effects, such as erythema, peeling, itching, and burning/stinging will be evaluated at each study visit. [ Time Frame: Weeks 6, 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Sun-damaged skin, caused by chronic exposure to ultraviolet (UV) light, is characterized by features such as wrinkling, uneven skin color, roughness and brown spots. An effective treatment for sun-damage that is commonly prescribed is topical retinoic acid. However, the major drawback of topical retinoic acid use has been frequently observed irritation characterized by redness, dry skin and severe itching. In this study, we examine whether a daily skin care regimen comprised of an ultra mild cleanser and an effective moisturizer can help improve tolerance to retinoid treatment.
Subjects for whom retinoid treatment is indicated for sun-damage will be recruited into the study. The retinoid intolerance will be established via prior history (detailed questionnaire) and a 2-week retinoid treatment (Tazarotene 0.1% cream) phase followed by clinical evaluation and determination of retinoid intolerance.
Subjects that exhibit retinoid intolerance will continue with the study. Approximately 30 subjects will be put on a controlled daily skin care regimen during the remainder of the study period while the rest of the subjects will continue their normal skin care habits. The controlled skin care regimen will consist of facial cleansing with a Dove ultra mild emollient cleanser and application of Dove facial moisturizer, used as normal. During this period, subjects will be evaluated to determine reduction of retinoid intolerance symptoms.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440024
|United States, Michigan|
|University of Michigan Department of Dermatology|
|Ann Arbor, Michigan, United States, 48109|
|Study Director:||Sewon Kang, MD||University of Michigan|