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| Name | Class |
|---|---|
| National Alopecia Areata Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients receiving Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone Acetonide 10 mg/mL (Kenalog-10) | Drug | Triamcinolone Acetonide 10 mg/ml (Kenalog-10) intralesional injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, week 24 |
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Inclusion Criteria:
Subject has clinical diagnosis of alopecia areata.
Written informed consent and HIPAA authorization have been obtained.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Maria K Hordinsky, MD | University of Minnesota | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | (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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
15 completed the study and were used for analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | (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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who completed all treatment and follow-up visits | Posted | Mean | Standard Deviation | mg/dL | baseline, week 24 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | (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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Hordinsky, MD | University of Minnesota | 612-624-5721 | hordi001@umn.edu |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 18 |
| 17 |
| 18 |
| anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| atrophy of scalp | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| benign keratosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Broken left elbow | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| erythema of ear canal | Ear and labyrinth disorders | Non-systematic Assessment |
|
| excoriations | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| facial flushing | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| feelings of sadness | Psychiatric disorders | Non-systematic Assessment |
|
| influenza | Infections and infestations | Non-systematic Assessment |
|
| folliculitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Headaches | General disorders | Non-systematic Assessment |
|
| increased number of telantascias along frontal hair line | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Increase scalp hair loss | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Irregular periods | Reproductive system and breast disorders | Non-systematic Assessment |
|
| conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| throat erythema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| nasal septal fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| intermittant nose bleeds | General disorders | Non-systematic Assessment |
|
| pinguecula | Eye disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Restless leg syndrome | Nervous system disorders | Non-systematic Assessment |
|
| scale in ear canal | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| tonsilar gland enlargement | General disorders | Non-systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| vaginal bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
|
| vaginal yeast infection | Infections and infestations | Non-systematic Assessment |
|
| worsening ear dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| xerotic skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |