Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alopecia Areata |
Drug: Triamcinolone Acetonide 10 mg/mL (Kenalog-10) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata |
- Normal adrenal function. [ Time Frame: While receiving Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections. ] [ Designated as safety issue: Yes ]
| Enrollment: | 30 |
| Study Start Date: | May 2007 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
|
Detailed Description:
- 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.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00484679 History of Changes |
| Other Study ID Numbers: | 0609M91989 |
| Study First Received: | June 8, 2007 |
| Last Updated: | December 8, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Alopecia Alopecia Areata Hypotrichosis Hair Diseases Skin Diseases Pathological Conditions, Anatomical Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Anti-Inflammatory Agents |
Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013