Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata
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|ClinicalTrials.gov Identifier: NCT00484679|
Recruitment Status : Completed
First Posted : June 11, 2007
Results First Posted : June 20, 2014
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alopecia Areata||Drug: Triamcinolone Acetonide 10 mg/mL (Kenalog-10)||Phase 2|
- To determine the effects of intralesional Triamcinolone Acetonide 10mg/cc (Kenalog 10) use for the treatment of alopecia areata on adrenal function.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||March 2011|
Patients receiving Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections.
Drug: Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
Triamcinolone Acetonide 10 mg/ml (Kenalog-10) intralesional injection
Other Name: Kenalog 10
- Mean Change in Cortisol Levels From Baseline to Week 24 [ Time Frame: baseline, week 24 ]Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484679
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Study Director:||Maria K Hordinsky, MD||University of Minnesota - Clinical and Translational Science Institute|