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Sponsors and Collaborators: |
University of Minnesota National Alopecia Areata Foundation |
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Information provided by: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT00484679 |
The purpose of the study is to see whether treating alopecia areata with injections of the corticosteroid, Kenalog-10, has an impact on the adrenal glands.
Condition | Intervention | Phase |
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Alopecia Areata |
Drug: Triamcinolone Acetonide 10 mg/mL |
Phase II |
Study Type: | Interventional |
Study Design: | Screening, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL in Patients With Alopecia Areata |
Estimated Enrollment: | 50 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Patients receiving Triamcinolone Acetonide 10 ml intralesional injections.
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Drug: Triamcinolone Acetonide 10 mg/mL
Triamcinolone Acetonide 10 mg/ml intralesional injection
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Approximately 30 subjects with moderate to severe alopecia areata will be enrolled.
Subjects will undergo intralesional triamcinolone acetonide (10mg/cc) 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 injections and other study data will be collected, such as SALT scores and physician assessments of AA, during the time between blood draws.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Written informed consent and HIPAA authorization have been obtained.
Exclusion Criteria:
Contact: Cathlelen M Boeck, RN, CCRC, DNC | 612-625-4973 | boeck001@umn.edu |
United States, Minnesota | |
University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Cathleen M Boeck, RN, CCRC, DNC 612-625-4973 boeck001@umn.edu |
Study Director: | Maria K Hordinsky, MD | University of Minnesota |
Responsible Party: | University of Minnesota ( Maria Hordinsky, MD ) |
Study ID Numbers: | 0609M91989 |
Study First Received: | June 8, 2007 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00484679 History of Changes |
Health Authority: | United States: Institutional Review Board |
Pathological Conditions, Anatomical Anti-Inflammatory Agents Immunologic Factors Skin Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Triamcinolone diacetate Immunosuppressive Agents |
Glucocorticoids Hormones Triamcinolone hexacetonide Alopecia Areata Triamcinolone Acetonide Alopecia Triamcinolone Epinephrine |
Hair Diseases Pathological Conditions, Anatomical Anti-Inflammatory Agents Hypotrichosis Molecular Mechanisms of Pharmacological Action Immunologic Factors Skin Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Triamcinolone diacetate |
Immunosuppressive Agents Hormones Glucocorticoids Pharmacologic Actions Triamcinolone hexacetonide Alopecia Areata Triamcinolone Acetonide Alopecia Therapeutic Uses Triamcinolone |