Retinol in Aged Skin - Full Text View

Sponsored by:	University of Michigan
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00857610

Purpose

Topical therapy with retinoids is the only proven medical therapy for aged/photoaged human skin. However, topical therapy with retinoids often result in unwanted cutaneous dermatitis, including erythema and scaling.

The reseachers intend to investigate the dose, frequency of use, and time dependence of topical retinol-induced dermatitis. The researchers intend to evaluate retinoid-induced dermatitis biochemically, including retinol regulation of retinoid responsive genes that control retinoid metabolism and serve as markers for retinoid bioactivity. The researchers will also investigate the role of EGF receptor pathway in retinoid-induced dermatitis.

Condition
Aged Skin Photoaged Skin

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Molecular Analyses of Retinoid-Induced Dermatitis in Aged/Photoaged Human Skin

Resource links provided by NLM:

Drug Information available for: Retinol

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Retinoid-induced dermatitis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Skin biopsies will be taken; however, they are not intended to be used for DNA extraction.

Estimated Enrollment:	250
Study Start Date:	April 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Subjects using 0.1% retinol one day per week
2 Subjects using 0.1% retinol three days per week
3 Subjects using 0.1% retinol seven days per week
4 Subjects using 0.5% retinol one day per week
5 Subjects using 0.5% retinol three days per week
6 Subjects using 0.5% retinol seven times per week

Eligibility

Ages Eligible for Study:	50 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Subjects will be between the ages of 50-60 years of age, with moderate clinical photodamage, and either gender.

Criteria

Inclusion Criteria:

Male or female
Clinical photodamage, typically greater than 40 years of age
Good general health
No disease states, physical conditions or medications that would impair evaluation of the test sites
Willingness and ability to follow protocol
Signed written and witnessed informed consent form

Exclusion Criteria:

Has received an experimental drug or used and experimental device in the 14 days prior to admission to the study
History of keloids
History of hypersensitivity to lidocaine or epinephrine
Pregnant or nursing women
Disease states or physical condition that would impair evaluation of the test sites or compliance with the protocol
History of chemical peels or laser treatments to the sites evaluated

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857610

Contacts

Contact: Suzan Rehbine	734-763-8076	srehbine@med.umich.edu
Contact: Mandy Harting, MD	734-232-2220	mandyhar@med.umich.edu

Sponsors and Collaborators

University of Michigan

More Information

No publications provided

Responsible Party:	University of Michigan ( Mandy Harting, MD )
Study ID Numbers:	Ret-1
Study First Received:	March 5, 2009
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00857610 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

Aged skin
Photoaged skin
Retinol
Topical retinoids

Study placed in the following topic categories:

Retinol
Retinol palmitate
Vitamin A
Dermatitis

ClinicalTrials.gov processed this record on September 10, 2009