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

Sponsor:	University of Minnesota - Clinical and Translational Science Institute
Collaborator:	National Alopecia Areata Foundation
Information provided by:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00484679

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 II

Study Type:	Interventional
Study Design:	Screening, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: androgenetic alopecia

MedlinePlus related topics: Hair Problems

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

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

Primary Outcome Measures:

Normal adrenal function. [ Time Frame: While receiving Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	May 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

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

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

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

Contacts

Contact: Maria Hordinsky, MD	612-625-1493	hordi001@umn.edu
Contact: Rina S Farah, Study Coord	612-625-4973	fara0050@umn.edu

Locations

United States, Minnesota
University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Rina Farah 612-625-4973 fara0050@umn.edu

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 ( Maria Hordinsky, MD )
Study ID Numbers:	0609M91989
Study First Received:	June 8, 2007
Last Updated:	January 29, 2010
ClinicalTrials.gov Identifier:	NCT00484679 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Hair Diseases
Pathological Conditions, Anatomical
Anti-Inflammatory Agents
Hypotrichosis
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Skin Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Triamcinolone diacetate

Immunosuppressive Agents
Hormones
Glucocorticoids
Pharmacologic Actions
Triamcinolone hexacetonide
Alopecia Areata
Triamcinolone Acetonide
Alopecia
Therapeutic Uses
Triamcinolone

ClinicalTrials.gov processed this record on February 04, 2010