Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata
Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alopecia Areata
Intervention: Triamcinolone Acetonide 10 mg/mL (Kenalog-10) (Drug)
Phase: Phase 2
Sponsored by: University of Minnesota - Clinical and Translational Science Institute
Official(s) and/or principal investigator(s):
Maria K Hordinsky, MD, Study Director, Affiliation: University of Minnesota - Clinical and Translational Science Institute
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
Official title: Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Primary outcome: Mean Change in Cortisol Levels From Baseline to Week 24
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
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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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.
- 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
- 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
- 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.
Locations and Contacts
University of Minnesota, Minneapolis, Minnesota 55455, United States
Starting date: May 2007
Last updated: May 20, 2014