Condition(s) treated: Sun-Damaged Skin; Retinoid Intolerance

Intervention: Tazorac (Drug); Dove Mild Cleanser (Drug); Dove Facial Moisturizer (Drug)

Enrollment status: Recruiting

Sponsor: University of Michigan

Principal investigator(s) or official(s):
Sewon Kang, MD, Study Director, Affiliation: University of Michigan

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.

Official title: A Single-Blind Study to Assess Benefits of a Controlled Daily Skin Care Regimen on Retinoid Intolerant Patients (Derm 570)

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome:
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))

Secondary outcome: 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)

Detailed description: 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.

Minimum eligible age: 40 Years. Maximum eligible age: 90 Years. Eligible gender(s): Both.

Criteria:

Inclusion Criteria:

- Caucasians between the ages of 40 and 90 with moderate to severe sun-damage on the

face who are generally healthy may participate.

- You must demonstrate a previous history of retinoid intolerance (established through

prior history and the 2-week retinoid treatment phase of this study).

- Women of childbearing potential must agree to use an accepted form of birth control

for the entire duration of the study.

- You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be

able to attend all of the scheduled appointments during the study.

Exclusion Criteria:

- You may not have used any topical or systemic retinoids in the past 6 months.

- Women who are pregnant or nursing may not participate.

- If you have a history of non-melanoma skin cancer on the face in the past 5 years, you

may not participate.

- If you have any history of malignant melanoma you may not participate.

- If you have any other skin condition or facial hair that will interfere with the study

evaluations, you may not participate.

- If you have a known sensitivity to any of the ingredients in the study cream or Dove

products, you may not participate.

- If you are currently on special daily skin care regimens that include cleansing with

Dove, Olay, Aveeno or Cetaphil liquid facial cleansers and using facial moisturizers more than twice a day you may not participate.

University of Michigan Department of Dermatology, Ann Arbor, Michigan 48109, United States; Recruiting
Kathryn Keeley, Email: ktkeeley@umich.edu
Ted A Hamilton, MS, Email: tedah@umich.edu
Dana Sachs, MD, Principal Investigator

Start date: February 2007
End date: February 2011
Last updated: June 2, 2008

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