An interventional study of Tazorac and Dove Mild Cleanser in Sun-Damaged Skin and Retinoid Intolerance, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-13.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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 (RA). However, the major drawback of topical RA 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 RA treatment.
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.
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This study's enrollment of 40 is below the median of 60 across 372 interventional studies indexed under Skin Diseases.
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Exclusion Criteria:
Study controlled daily skin care regimen during 'rest period' consisting of Dove Mild Cleanser, Dove Facial Moisturizer with SPF 15 followed by Tazorac
Drug: Tazorac · Drug: Dove Mild Cleanser · Drug: Dove Facial Moisturizer
Subject controlled normal skin care regimen during 'rest period, followed by study controlled daily skin care regime consisting of Dove Mild Cleanser, Dove Facial Moisturizer with SPF 15 followed by Tazorac
Drug: Tazorac · Drug: Dove Mild Cleanser · Drug: Dove Facial Moisturizer
Tazarotene 0.1% cream applied to the face once daily before bed
Also known as: Tazarotene
Ultra mild cleanser: Dove Non-foaming cleansing lotion
Also known as: Dove Non-foaming Cleanser
Moisturizing cream - Dove facial moisturizer with SPF 15
Retinoid irritation symptoms
Time frame: Weeks 6, 8, 12, 16, 20 and 24
Improvement of sun-damage (wrinkling, uneven skin color, roughness and brown spots).
Time frame: At the end of the study (week 24)
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
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Michigan