Retinol-induced Dermatitis in Aged Skin

Aged Skin Clinical Trial

Official title:

Molecular Analyses of Retinoid-induced Dermatitis in Aged/Photoaged Human Skin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857610
• Other study ID #: HUM00026851/ Derm 604
• Status: Completed
• Start date: July 20, 2009
• Est. completion date: August 29, 2014

Study information

• Verified date: March 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 29, 2014
• Est. primary completion date: August 29, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Aged Skin
• Dermatitis
• Photoaged Skin

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinoid-induced dermatitis		6 months