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
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|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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
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|
|Responsible Party:||University of Minnesota|
|Other Study ID Numbers:||
|First Posted:||June 11, 2007 Key Record Dates|
|Results First Posted:||June 20, 2014|
|Last Update Posted:||June 29, 2018|
|Last Verified:||April 2017|
Pathological Conditions, Anatomical
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action