The Effect Of A Controlled Daily Skin Care Regimen On Retinoic Acid Tolerance

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Sun-Damaged Skin, Retinoid Intolerance

Intervention / Treatment
-----------------
* Drug: Tazorac
* Drug: Dove Mild Cleanser
* Drug: Dove Facial Moisturizer


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cell A<br>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<br>* Tazarotene 0.1% cream applied to the face once daily before bed<br>* Other names: Tazarotene;Drug: Dove Mild Cleanser<br>* Ultra mild cleanser: Dove Non-foaming cleansing lotion<br>* Other names: Dove Non-foaming Cleanser;Drug: Dove Facial Moisturizer<br>* Moisturizing cream - Dove facial moisturizer with SPF 15<br>|
| Placebo Comparator: Cell B<br>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<br>* Tazarotene 0.1% cream applied to the face once daily before bed<br>* Other names: Tazarotene;Drug: Dove Mild Cleanser<br>* Ultra mild cleanser: Dove Non-foaming cleansing lotion<br>* Other names: Dove Non-foaming Cleanser;Drug: Dove Facial Moisturizer<br>* Moisturizing cream - Dove facial moisturizer with SPF 15<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinoid irritation symptoms |  | Weeks 6, 8, 12, 16, 20 and 24 | 
| Improvement of sun-damage (wrinkling, uneven skin color, roughness and brown spots). |  | At the end of the study (week 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment effects, such as erythema, peeling, itching, and burning/stinging will be evaluated at each study visit. |  | Weeks 6, 8, 12, 16, 20 and 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sun-Damaged Skin, Retinoid Intolerance, Tazarotene Cream, Dove facial cleanser, Dove moisturizer