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

Retinoid Intolerance Clinical Trial

Official title:

A Single-Blind Study to Assess Benefits of a Controlled Daily Skin Care Regimen on Retinoid Intolerant Patients (Derm 570)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440024
• Other study ID #: Derm 570
• Status: Completed
• Phase: N/A
• Start date: February 2007
• Est. completion date: November 2009

Study information

• Verified date: March 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Retinoid Intolerance
• Sun-Damaged Skin

Intervention

Drug:
• Tazorac
Tazarotene 0.1% cream applied to the face once daily before bed
• Dove Mild Cleanser
Ultra mild cleanser: Dove Non-foaming cleansing lotion
• Dove Facial Moisturizer
Moisturizing cream - Dove facial moisturizer with SPF 15

Locations

Country	Name	City	State
United States	University of Michigan Department of Dermatology	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Unilever R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinoid irritation symptoms		Weeks 6, 8, 12, 16, 20 and 24
Primary	Improvement of sun-damage (wrinkling, uneven skin color, roughness and brown spots).		At the end of the study (week 24)
Secondary	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