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

This study has been completed.
Sponsor:
Collaborator:
National Alopecia Areata Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00484679
First received: June 8, 2007
Last updated: May 20, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Mean Change in Cortisol Levels From Baseline to Week 24 [ Time Frame: baseline, week 24 ] [ Designated as safety issue: Yes ]
    Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart.


Enrollment: 18
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:
  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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484679

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Alopecia Areata Foundation
Investigators
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
Results First Received: February 27, 2013
Last Updated: May 20, 2014
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 August 25, 2014