- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00440024
The Effect Of A Controlled Daily Skin Care Regimen On Retinoic Acid Tolerance
A Single-Blind Study to Assess Benefits of a Controlled Daily Skin Care Regimen on Retinoid Intolerant Patients (Derm 570)
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Department of Dermatology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cell A
Study controlled daily skin care regimen during 'rest period' consisting of Dove Mild Cleanser, Dove Facial Moisturizer with SPF 15 followed by Tazorac
|
Tazarotene 0.1% cream applied to the face once daily before bed
Other Names:
Ultra mild cleanser: Dove Non-foaming cleansing lotion
Other Names:
Moisturizing cream - Dove facial moisturizer with SPF 15
|
PLACEBO_COMPARATOR: Cell B
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
|
Tazarotene 0.1% cream applied to the face once daily before bed
Other Names:
Ultra mild cleanser: Dove Non-foaming cleansing lotion
Other Names:
Moisturizing cream - Dove facial moisturizer with SPF 15
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Retinoid irritation symptoms
Time Frame: Weeks 6, 8, 12, 16, 20 and 24
|
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)
|
At the end of the study (week 24)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Weeks 6, 8, 12, 16, 20 and 24
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dana Sachs, MD, University of Michigan
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Derm 570
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sun-Damaged Skin
-
University of California, DavisCompletedSun Damaged SkinUnited States
-
Henry Ford Health SystemL'OrealActive, not recruitingSun Damaged SkinUnited States
-
University of ArizonaNational Cancer Institute (NCI)CompletedSun Damaged SkinUnited States
-
Vitality Institute Medical ProductsCompletedWrinkle | Photoaging | Sun Damaged SkinUnited States
-
Pierre Fabre Dermo CosmetiqueCompleted
-
Sun Protection FoundationEnrolling by invitationSunburn | Sun Damaged Skin | Overexposure to Sun RaysUnited States, Chile, Peru
-
Bispebjerg HospitalGalderma R&DCompletedActinic Keratosis | Sun Damaged Skin | Solar Keratosis | Solar Skin Damage
-
Amazentis SAproDERM GmbHCompletedErythema | Skin Inflammation | Sun Damaged SkinGermany
-
Medical Dermatology SpecialistsDUSA Pharmaceuticals, Inc.CompletedActinic Keratosis | Skin Cancer | Non-melanoma Skin Cancer | Sun Damaged SkinUnited States
-
Dana-Farber Cancer InstituteNovartisCompletedMucosal Melanoma | Acral/Lentiginous Melanoma | Chronically Sun Damaged MelanomasUnited States
Clinical Trials on Tazorac
-
Bausch Health Americas, Inc.Completed
-
G & W Laboratories Inc.CompletedPlaque PsoriasisUnited States
-
Bausch Health Americas, Inc.CompletedAcne VulgarisUnited States
-
Bausch Health Americas, Inc.Completed
-
UCSF Benioff Children's Hospital OaklandNational Cancer Institute (NCI)CompletedNeoplastic SyndromeUnited States
-
Columbia UniversityAllerganCompletedBrittle NailsUnited States
-
Stewart, Roger H., M.D., P.A.CompletedACTINIC KERATOSESUnited States
-
UCSF Benioff Children's Hospital OaklandNational Cancer Institute (NCI)Completed
-
McGill UniversityUnknownCutaneous T-Cell LymphomaCanada
-
Dana-Farber Cancer InstituteBayerTerminatedSolid Tumor | Hand-Foot Skin Reaction (HFSR)United States