NCT00484679

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

1. To determine the effects of intralesional Triamcinolone Acetonide 10mg/cc (Kenalog 10) use for the treatment of alopecia areata on adrenal function. 2. To evaluate the efficacy of intralesional corticosteroids (Kenalog-10)on hair regrowth in moderate to severe alopecia areata. 18 subjects with moderate to severe alopecia areata were enrolled and 15 subjects completed all study visits. Subjects underwent intralesional triamcinolone acetonide (10mg/cc) (Kenalog-10) injections every 6 weeks for a period of 6 months in the General Clinical Research Center (GCRC). This period was followed by a 6 week, injection-free, safety follow-up visit. Adrenal function was assessed by utilization of the Low Dose Adrenocorticotropic Hormone Stimulation Test (ACTH) which measures adrenal gland production of cortisol after exogenously administered ACTH. Serum blood draws of 3 mL were done at baseline and 6-week intervals at the start of each scheduled appointment for intralesional treatment at approximately 0800 hours. Two blood draws were taken at time 0 and again 30 minutes after a 1 mcg bolus dose of synthetic ACTH (Cortrosyn). Patients underwent their scheduled course of intralesional corticosteroid (Kenalog-10) injections and other study data was collected, such as SALT scores and physician assessments of AA, during the time between blood draws.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	Triamcinolone Acetonide 10 mg/mL (Kenalog-10)	Triamcinolone Acetonide 10 mg/ml (Kenalog-10) intralesional injection

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-06-01
• Completion: 2011-03-01
• First posted: 2007-06-11
• Last updated: 2018-06-29
• Results posted: 2014-06-20

Locations

1 site across 1 country: United States