Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440024
Status:
COMPLETED
Last Update Posted:
2020-03-13
First Post:
2007-02-22
Brief Title:
The Effect Of A Controlled Daily Skin Care Regimen On Retinoic Acid Tolerance
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
A Single-Blind Study to Assess Benefits of a Controlled Daily Skin Care Regimen on Retinoid Intolerant Patients Derm 570
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 01 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
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 01 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None