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

Information source: University of Minnesota - Clinical and Translational Science Institute
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alopecia Areata

Intervention: Triamcinolone Acetonide 10 mg/mL (Kenalog-10) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Minnesota - Clinical and Translational Science Institute

Official(s) and/or principal investigator(s):
Maria K Hordinsky, MD, Study Director, Affiliation: University of Minnesota - Clinical and Translational Science Institute

Overall contact:
Maria Hordinsky, MD, Phone: 612-625-1493, Email: hordi001@umn.edu

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Primary outcome: Normal adrenal function.

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.

Approximately 30 subjects with moderate to severe alopecia areata will be enrolled.

Subjects will undergo 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 will be followed by a 6 week, injection-free, safety follow-up visit. Adrenal function will be 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 will be done at baseline and 6-week intervals at the start of each scheduled appointment for intralesional treatment at approximately 0800 hours. Two blood draws will be taken at time 0 and again 30 minutes after a 1 mcg bolus dose of synthetic ACTH (Cortrosyn).

Patients will undergo their scheduled course of intralesional corticosteroid (Kenalog-10) injections and other study data will be collected, such as SALT scores and physician assessments of AA, during the time between blood draws.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Maria Hordinsky, MD, Phone: 612-625-1493, Email: hordi001@umn.edu

University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting
Rina Farah, Phone: 612-625-4973, Email: fara0050@umn.edu
Additional Information

Starting date: May 2007
Last updated: January 29, 2010

Page last updated: October 04, 2010

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