Alopecia Areata
Conditions
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
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.
Interventions
DRUGTriamcinolone Acetonide 10 mg/mL (Kenalog-10)
Triamcinolone Acetonide 10 mg/ml (Kenalog-10) intralesional injection
Sponsors
National Alopecia Areata Foundation
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Cortisol Levels From Baseline to Week 24 | baseline, week 24 | Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| (Kenalog-10) Intralesional Injections for Alopecia Areata Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | (Kenalog-10) Intralesional Injections for Alopecia Areata |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 46.6 years STANDARD_DEVIATION 14.53 |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
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.
Time frame: baseline, week 24
Population: Participants who completed all treatment and follow-up visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| (Kenalog-10) Intralesional Injections for Alopecia Areata | Mean Change in Cortisol Levels From Baseline to Week 24 | 0.187 mg/dL | Standard Deviation 6.019 |