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The investigators hypothesize that Restylane® could serve as a repair matrix which also maintains IL triamcinolone acetonide concentrations at higher levels for a longer period of time in the skin, giving a more sustained local anti-inflammatory effect and thus, arresting the AA process and promoting hair regrowth. Furthermore, the combination of Restylane® with IL triamcinolone acetonide injections may prevent a common side effect, atrophy. With the prevention of scalp atrophy and the preservation of higher concentrations of triamcinolone acetonide for longer periods of time, patients may see a better clinical response for a longer period of time. Quality of life may improve as the number of clinic visits decreases as would the number of IL corticosteroid injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined IL Kenalog and Restylane | Experimental | Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) | Drug | Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline | The primary endpoint of evaluating the efficacy of administration of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA is the alopecia areata half head severity score (AAHHSS) comparing week 12 with baseline hair loss. Four discreet areas of the scalp are examined. The percent of terminal hair loss in each area is measured by visual estimation. Those percent figures are multiplied by the total area on one half of the scalp represented by the four respective areas. 1) Left parietal scalp (18% of area), right parietal scalp (18% of area), frontal scalp (40% of area), and occipital scalp (24% of area). Scores range from 0 to 50, with higher scores indicating more hair loss. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events Reported by Subjects | To assess the safety of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Hordinsky, MD | University of Minnesota - Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Department of Dermatology | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combined IL Kenalog and Restylane | Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10): Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp Restylane: Intralesional injections of 2mLs of Restylane on one side of the scalp |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Combined IL Kenalog and Restylane | Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10): Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp Restylane: Intralesional injections of 2mLs of Restylane on one side of the scalp |
| 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 | Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline | The primary endpoint of evaluating the efficacy of administration of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA is the alopecia areata half head severity score (AAHHSS) comparing week 12 with baseline hair loss. Four discreet areas of the scalp are examined. The percent of terminal hair loss in each area is measured by visual estimation. Those percent figures are multiplied by the total area on one half of the scalp represented by the four respective areas. 1) Left parietal scalp (18% of area), right parietal scalp (18% of area), frontal scalp (40% of area), and occipital scalp (24% of area). Scores range from 0 to 50, with higher scores indicating more hair loss. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
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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 | Combined IL Kenalog and Restylane | Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10): Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp Restylane: Intralesional injections of 2mLs of Restylane on one side of the scalp |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchial Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Hordinsky, MD | University of Minnesota | 612-625-6118 | hordi001@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2013 | Oct 30, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 17, 2014 | Oct 30, 2020 | ICF_001.pdf |
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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 |
|---|---|
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Restylane | Device | Intralesional injections of 2mLs of Restylane on one side of the scalp |
|
| lived too far from study site |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Adverse Events Reported by Subjects | To assess the safety of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA. | Posted | Number | adverse events | 12 weeks |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 11 |
| 14 |
| Shingles | Infections and infestations |
|
| Bladder Infection | Renal and urinary disorders |
|
| Migraine Headache | General disorders |
|
| Cold Sore | Immune system disorders |
|
| Fatigue | General disorders |
|
| Allergic Reaction | Immune system disorders |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders |
|
| Pain at Injection Site | Skin and subcutaneous tissue disorders |
|
| Irregular Menstrual Cycle | Reproductive system and breast disorders |
|
| Cold/flu | Infections and infestations |
|
| Headache | General disorders |
|
| Difficulty Concentrating | General disorders |
|
| Traveler's Diarrhea | Gastrointestinal disorders |
|
| Acne | Skin and subcutaneous tissue disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Eczema | Skin and subcutaneous tissue disorders |
|
| Hives | Immune system disorders |
|
| Bump on Head | Injury, poisoning and procedural complications |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |