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Retinol-induced Dermatitis in Aged Skin

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Dana L. Sachs, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT00857610
First received: March 5, 2009
Last updated: October 17, 2016
Last verified: October 2016
  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:


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: 200
Study Start Date: April 2009
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (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:   21 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be between the ages of 21-60 years of age, with moderate clinical photodamage, and either gender.
Criteria

Inclusion Criteria:

  • Male or female
  • Subject is at least 21 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
  • No use of oral retnoids in the past year
  • No use of topical steroids to the treatment area in the past 2 weeks

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Suzan Rehbine 734-763-8076 srehbine@med.umich.edu

Locations
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Suzan Rehbine    734-763-8076    srehbine@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Dana Sachs, MD University of Michigan Professor of Dermatology
  More Information

Responsible Party: Dana L. Sachs, MD, Professor of Dermatology, University of Michigan
ClinicalTrials.gov Identifier: NCT00857610     History of Changes
Other Study ID Numbers: HUM00026851/ Derm 604 
Study First Received: March 5, 2009
Last Updated: October 17, 2016
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Dermatitis
Skin Diseases
Vitamin A
Retinol palmitate
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 06, 2016