Back to resultsAdrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata
Primary Purpose
Alopecia Areata
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
Sponsored by
About this trial
This is an interventional screening trial for Alopecia Areata
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.
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Patients receiving Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections.
Outcomes
Primary Outcome Measures
Mean Change in Cortisol Levels From Baseline to Week 24
Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart.
Secondary Outcome Measures
Full Information
NCT ID
NCT00484679
First Posted
June 8, 2007
Last Updated
May 30, 2018
Sponsor
University of Minnesota
Collaborators
National Alopecia Areata Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00484679
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Alopecia Areata Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients receiving Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
Other Intervention Name(s)
Kenalog 10
Intervention Description
Triamcinolone Acetonide 10 mg/ml (Kenalog-10) intralesional injection
Primary Outcome Measure Information:
Title
Mean Change in Cortisol Levels From Baseline to Week 24
Description
Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart.
Time Frame
baseline, week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria K Hordinsky, MD
Organizational Affiliation
University of Minnesota
Official's Role
Study Director
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata
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