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

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Brief Title

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

Official Title

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

Brief 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.
    

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.

      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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Mean Change in Cortisol Levels From Baseline to Week 24


Condition

Alopecia Areata

Intervention

Triamcinolone Acetonide 10 mg/mL (Kenalog-10)

Study Arms / Comparison Groups

 1
Description:  Patients receiving Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

18

Start Date

May 2007

Completion Date

March 2011

Primary Completion Date

June 2009

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Maria K Hordinsky, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00484679

Organization ID

0609M91989


Responsible Party

Sponsor

Study Sponsor

University of Minnesota

Collaborators

 National Alopecia Areata Foundation

Study Sponsor

Maria K Hordinsky, MD, Study Director, University of Minnesota


Verification Date

April 2017