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Retinol-induced Dermatitis in Aged Skin

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Photoaged Skin
Aged Skin

Study type

Observational

Funder types

Other

Identifiers

NCT00857610
HUM00026851/ Derm 604

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

21 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

41 participants in 6 patient groups

1
Description:
Subjects using 0.1% retinol one day per week
2
Description:
Subjects using 0.1% retinol three days per week
3
Description:
Subjects using 0.1% retinol seven days per week
4
Description:
Subjects using 0.5% retinol one day per week
5
Description:
Subjects using 0.5% retinol three days per week
6
Description:
Subjects using 0.5% retinol seven times per week

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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