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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
Sponsor:
Collaborator:
National Alopecia Areata Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Tracking Information
First Submitted Date  ICMJE June 8, 2007
First Posted Date  ICMJE June 11, 2007
Results First Submitted Date  ICMJE February 27, 2013
Results First Posted Date  ICMJE June 20, 2014
Last Update Posted Date June 29, 2018
Study Start Date  ICMJE May 2007
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00484679 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Alopecia Areata
Intervention  ICMJE Drug: Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
Triamcinolone Acetonide 10 mg/ml (Kenalog-10) intralesional injection
Other Name: Kenalog 10
Study Arms  ICMJE Experimental: 1
Patients receiving Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections.
Intervention: Drug: Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2014)
18
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2007)
50
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00484679
Other Study ID Numbers  ICMJE 0609M91989
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota - Clinical and Translational Science Institute
Study Sponsor  ICMJE University of Minnesota - Clinical and Translational Science Institute
Collaborators  ICMJE National Alopecia Areata Foundation
Investigators  ICMJE
Study Director: Maria K Hordinsky, MD University of Minnesota - Clinical and Translational Science Institute
PRS Account University of Minnesota - Clinical and Translational Science Institute
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP