Phase 2
N=18
Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata
Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT00484679 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Mean Change in Cortisol Levels From Baseline to Week 24 — 0.187 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Triamcinolone Acetonide 10 mg/mL (Kenalog-10) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Cortisol Levels From Baseline to Week 24 |
0.187 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00484679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.