Retinol-induced Dermatitis in Aged Skin

NCT00857610 | Completed

• 1 other identifier: HUM00026851/ Derm 604
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Aged Skin; Photoaged Skin

Keywords

Aged skin; Photoaged skin; Retinol; Topical retinoids

Outcome Measures

Primary Outcomes (1)

• Retinoid-induced dermatitis

  6 months

Study Arms (6)

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 Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

Study Officials

• Dana Sachs, MD

  University of Michigan Professor of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: July 20, 2009
• Primary Completion: August 29, 2014
• Study Completion: August 29, 2014
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

US (1)