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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00440024
First Posted: February 26, 2007
Last Update Posted: February 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Unilever R&D
Information provided by (Responsible Party):
Dana L. Sachs, MD, University of Michigan
  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
Intervention Model: Single Group Assignment
Masking: Single (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 Dana L. Sachs, MD, University of Michigan:

Primary Outcome Measures:
  • 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 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 ]

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)
Arms Assigned Interventions
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
Drug: Tazorac
Tazarotene 0.1% cream applied to the face once daily before bed
Other Name: Tazarotene
Drug: Dove Mild Cleanser
Ultra mild cleanser: Dove Non-foaming cleansing lotion
Other Name: Dove Non-foaming Cleanser
Drug: Dove Facial Moisturizer
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
Drug: Tazorac
Tazarotene 0.1% cream applied to the face once daily before bed
Other Name: Tazarotene
Drug: Dove Mild Cleanser
Ultra mild cleanser: Dove Non-foaming cleansing lotion
Other Name: Dove Non-foaming Cleanser
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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Principal Investigator: Dana Sachs, MD University of Michigan
  More Information

Responsible Party: Dana L. Sachs, MD, Professor of Dermatology, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT00440024     History of Changes
Other Study ID Numbers: Derm 570
First Submitted: February 22, 2007
First Posted: February 26, 2007
Last Update Posted: February 28, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dana L. Sachs, MD, University of Michigan:
Sun-Damaged Skin
Retinoid Intolerance
Tazarotene Cream
Dove facial cleanser
Dove moisturizer

Additional relevant MeSH terms:
Tazarotene
Dermatologic Agents
Keratolytic Agents