Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to see whether treating alopecia areata with injections of the corticosteroid, Triamcinolone acetonide 10mg/cc (Kenalog-10), has an impact on the adrenal glands.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: National Alopecia Areata Foundation
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• Subject has clinical diagnosis of alopecia areata.

• Written informed consent and HIPAA authorization have been obtained.

• Female subjects of childbearing potential have a negative pregnancy test and agree to use an acceptable method of birth control to prevent pregnancy.

• In the opinion of the investigator, subject is a candidate for intralesional therapy for alopecia areata.

• Subject agrees to comply with protocol requirements and attend all required study visits and is considered to be a good study subject.

• Subject meets concomitant medication washout requirements.

• Subject is >/= 18 years of age.

Exclusion Criteria:

• Subject has alopecia universalis.

• Subject has known adrenocortical insufficiency or Cushing's Syndrome.

• Subject is pregnant or lactating.

• Subject has current controlled or uncontrolled bacterial, viral, fungal, atypical, or opportunistic infections.

• Subject possesses hypersensitivity to cortrosyn or Triamcinolone Acetonide (Kenalog-10) or any component of their formulation.

• Subject is currently or has undergone therapy for malignancy within the past five years.

• Subject has history of substance abuse within the past five years.

• Subject has used oral corticosteroids within the past 12 months.

• Subject has concurrent use of phenytion rifampin, phenobarbital, mitotane, or other formulations of corticosteroid medications.

• Subject has any medical condition that, in the judgement of the investigator, would jeopardize the subject's safety following exposure to the administered medications.