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Retinol in Aged Skin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University of Michigan.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00857610
First received: March 5, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Analyses of Retinoid-Induced Dermatitis in Aged/Photoaged Human Skin

Resource links provided by NLM:

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

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

Keywords provided by University of Michigan:
Aged skin
Photoaged skin
Retinol
Topical retinoids

Additional relevant MeSH terms:
Vitamin A
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013