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

This study has been completed.
Sponsor:
Collaborator:
Unilever R&D
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00440024
First received: February 22, 2007
Last updated: January 7, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Sun-Damaged Skin
Retinoid Intolerance
Drug: Tazorac
Drug: Dove Mild Cleanser
Drug: Dove Facial Moisturizer

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: February 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tazorac
    Tazarotene 0.1% cream applied to the face once daily before bed
    Drug: Dove Mild Cleanser
    Ultra mild cleanser: Dove Non-foaming cleansing lotion
    Drug: Dove Facial Moisturizer
    Moisturizing cream - Dove facial moisturizer with SPF 15
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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440024

Locations
United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Unilever R&D
Investigators
Study Director: Sewon Kang, MD University of Michigan
  More Information

No publications provided

Responsible Party: Dana Sachs, MD, Clinical Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00440024     History of Changes
Other Study ID Numbers: Derm 570
Study First Received: February 22, 2007
Last Updated: January 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Sun-Damaged Skin
Retinoid Intolerance
Tazarotene Cream
Dove facial cleanser
Dove moisturizer

Additional relevant MeSH terms:
Skin Diseases
Tazarotene
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents

ClinicalTrials.gov processed this record on August 20, 2014