Retinol-induced Dermatitis in Aged Skin

March 11, 2020 updated by: Dana L. Sachs, MD, University of Michigan

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retinoid-induced dermatitis
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Dana Sachs, MD, University of Michigan Professor of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2009

Primary Completion (Actual)

August 29, 2014

Study Completion (Actual)

August 29, 2014

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (Estimate)

March 6, 2009

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00026851/ Derm 604

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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