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

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484679
• Other study ID #: 0609M91989
• Status: Completed
• Phase: Phase 2
• Start date: May 2007
• Est. completion date: March 2011

Study information

• Verified date: April 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2011
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
Triamcinolone Acetonide 10 mg/ml (Kenalog-10) intralesional injection

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Alopecia Areata Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Cortisol Levels From Baseline to Week 24	Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart.	baseline, week 24