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Retinol-induced Dermatitis in Aged Skin

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ClinicalTrials.gov Identifier: NCT00857610
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Dana L. Sachs, MD, University of Michigan

Brief Summary:
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 or disease
Aged Skin Photoaged Skin

Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Analyses of Retinoid-induced Dermatitis in Aged/Photoaged Human Skin
Actual Study Start Date : July 20, 2009
Actual Primary Completion Date : August 29, 2014
Actual Study Completion Date : August 29, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Retinol

Group/Cohort
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



Primary Outcome Measures :
  1. Retinoid-induced dermatitis [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
Skin biopsies will be taken; however, they are not intended to be used for DNA extraction.


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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857610


Locations
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Dana Sachs, MD University of Michigan Professor of Dermatology

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
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Keywords provided by Dana L. Sachs, MD, 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