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

March 5, 2009
March 5, 2009
April 2009
June 2011   (final data collection date for primary outcome measure)
Retinoid-induced dermatitis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
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Retinol in Aged Skin
Molecular Analyses of Retinoid-Induced Dermatitis in Aged/Photoaged Human Skin

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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

  • Aged Skin
  • Photoaged Skin
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
250
June 2012
June 2011   (final data collection date for primary outcome measure)

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
Both
50 Years to 60 Years
Yes
Contact: Suzan Rehbine 734-763-8076 srehbine@med.umich.edu
Contact: Mandy Harting, MD 734-232-2220 mandyhar@med.umich.edu
Not Provided
 
NCT00857610
Ret-1
No
Mandy Harting, MD, University of Michigan
University of Michigan
Not Provided
Not Provided
University of Michigan
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP