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

Primary Purpose

Sun-Damaged Skin, Retinoid Intolerance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tazorac
Dove Mild Cleanser
Dove Facial Moisturizer
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sun-Damaged Skin focused on measuring Sun-Damaged Skin, Retinoid Intolerance, Tazarotene Cream, Dove facial cleanser, Dove moisturizer

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Michigan Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cell A

Cell B

Arm Description

Study controlled daily skin care regimen during 'rest period' consisting of Dove Mild Cleanser, Dove Facial Moisturizer with SPF 15 followed by Tazorac

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

Outcomes

Primary Outcome Measures

Retinoid irritation symptoms
Improvement of sun-damage (wrinkling, uneven skin color, roughness and brown spots).

Secondary Outcome Measures

Treatment effects, such as erythema, peeling, itching, and burning/stinging will be evaluated at each study visit.

Full Information

First Posted
February 22, 2007
Last Updated
March 11, 2020
Sponsor
University of Michigan
Collaborators
Unilever R&D
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1. Study Identification

Unique Protocol Identification Number
NCT00440024
Brief Title
The Effect Of A Controlled Daily Skin Care Regimen On Retinoic Acid Tolerance
Official Title
A Single-Blind Study to Assess Benefits of a Controlled Daily Skin Care Regimen on Retinoid Intolerant Patients (Derm 570)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Unilever R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sun-Damaged Skin, Retinoid Intolerance
Keywords
Sun-Damaged Skin, Retinoid Intolerance, Tazarotene Cream, Dove facial cleanser, Dove moisturizer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cell A
Arm Type
Experimental
Arm Description
Study controlled daily skin care regimen during 'rest period' consisting of Dove Mild Cleanser, Dove Facial Moisturizer with SPF 15 followed by Tazorac
Arm Title
Cell B
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Tazorac
Other Intervention Name(s)
Tazarotene
Intervention Description
Tazarotene 0.1% cream applied to the face once daily before bed
Intervention Type
Drug
Intervention Name(s)
Dove Mild Cleanser
Other Intervention Name(s)
Dove Non-foaming Cleanser
Intervention Description
Ultra mild cleanser: Dove Non-foaming cleansing lotion
Intervention Type
Drug
Intervention Name(s)
Dove Facial Moisturizer
Intervention Description
Moisturizing cream - Dove facial moisturizer with SPF 15
Primary Outcome Measure Information:
Title
Retinoid irritation symptoms
Time Frame
Weeks 6, 8, 12, 16, 20 and 24
Title
Improvement of sun-damage (wrinkling, uneven skin color, roughness and brown spots).
Time Frame
At the end of the study (week 24)
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Sachs, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Department of Dermatology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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

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