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

NCT ID: NCT00440024

Last Updated: 2020-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-11-30

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.

Conditions

Sun-Damaged Skin; Retinoid Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Tazorac

Intervention Type: DRUG

Tazarotene 0.1% cream applied to the face once daily before bed

Dove Mild Cleanser

Intervention Type: DRUG

Ultra mild cleanser: Dove Non-foaming cleansing lotion

Dove Facial Moisturizer

Intervention Type: DRUG

Moisturizing cream - Dove facial moisturizer with SPF 15

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

Group Type: PLACEBO_COMPARATOR

Tazorac

Intervention Type: DRUG

Tazarotene 0.1% cream applied to the face once daily before bed

Dove Mild Cleanser

Intervention Type: DRUG

Ultra mild cleanser: Dove Non-foaming cleansing lotion

Dove Facial Moisturizer

Intervention Type: DRUG

Moisturizing cream - Dove facial moisturizer with SPF 15

Interventions

Tazorac

Tazarotene 0.1% cream applied to the face once daily before bed

Intervention Type: DRUG

Dove Mild Cleanser

Ultra mild cleanser: Dove Non-foaming cleansing lotion

Intervention Type: DRUG

Dove Facial Moisturizer

Moisturizing cream - Dove facial moisturizer with SPF 15

Intervention Type: DRUG

Other Intervention Names

Tazarotene; Dove Non-foaming Cleanser

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unilever R&D

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Dana L. Sachs, MD

Professor of Dermatology, Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dana Sachs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Department of Dermatology

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

Derm 570

Identifier Type: -

Identifier Source: org_study_id