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

NCT00440024 | Completed

• 1 other identifier: Derm 570
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sun-Damaged Skin; Retinoid Intolerance

Keywords

Sun-Damaged Skin; Retinoid Intolerance; Tazarotene Cream; Dove facial cleanser; Dove moisturizer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (2)

Cell A

EXPERIMENTAL

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; Drug: Dove Mild Cleanser; Drug: Dove Facial Moisturizer

Cell B

PLACEBO COMPARATOR

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; Drug: Dove Mild Cleanser; Drug: Dove Facial Moisturizer

Interventions

Tazorac DRUG

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

Also known as: Tazarotene

Cell A; Cell B

Dove Mild Cleanser DRUG

Ultra mild cleanser: Dove Non-foaming cleansing lotion

Also known as: Dove Non-foaming Cleanser

Cell A; Cell B

Dove Facial Moisturizer DRUG

Moisturizing cream - Dove facial moisturizer with SPF 15

Cell A; Cell B

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Unilever R&D: collaborator

Study Sites (1)

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

tazarotene

Study Officials

• Dana Sachs, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology, Medical School

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 26, 2007
• Study Start: February 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

US (1)