Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Alopecia Areata |
Drug: Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) Device: Restylane |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata |
- Change in alopecia areata half head severity score (AAHHSS) at 12 weeks compared to baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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. The primary analysis will be a comparison of means of AAHHSS between two treatments on the two sides of AA patients scalp using paired t-tests.
- Number of adverse events reported by subjects [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]To assess the safety of IL triamcinolone acetonide10 mg/cc and Restylane® in the management of AA.
| Estimated Enrollment: | 10 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Combined IL Kenalog and Restylane
Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp
|
Drug: Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp
Other Name: Kenalog-10
Device: Restylane
Intralesional injections of 2mLs of Restylane on one side of the scalp
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women ages 18 and greater.
- Alopecia areata diagnosis in the last two years with extensive scalp involvement, between 74% and 99%, alopecia areata must involve the left and right hemispheres of the scalp.
- Willing to abstain from use of over the counter products and prescription products, other than study medications, which may promote hair growth.
- Willing to abstain from the use of non-steroidal anti-inflammatory medications, aspirin, St. Johns Wart, and high doses of Vitamin E supplementation.
- Subjects are capable of giving informed consent.
- Willing to adhere to protocol, including scalp examinations and photography.
Exclusion Criteria:
- Allergy or intolerance to Restylane® or hyaluronate preparations
- Allergy or intolerance to triamcinolone acetonide, 10 mg/cc.
- Underlying disease that might be adversely affected by Restylane® or triamcinolone (ex. patients with bleeding disorders).
- Immunosuppressed patients (history of transplantation, cancer, chemotherapy, splenectomy, HIV).
- Pregnant or lactating female.
- Application of topical immunomodulatory or immunosuppressive agent in the preceding 6 weeks.
- Systemic administration of corticosteroid or other systemic treatment (i.e. prednisone) that has immunomodulatory or other immunosuppressive mechanism of action, in the preceding 8 weeks.
- Clinical evidence of secondary skin infection (i.e., folliculitis).
- Other inflammatory or infectious skin disease that might interfere with evaluations during the study.
- Investigational medications within the past 30 days.
- Patients with susceptibility to keloid formation.
- Severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies
- Patients with allergies to gram positive bacterial proteins
- Unable to give consent.
Contacts and Locations| Contact: Heather Bemmels, MS | 612-625-9338 | bemm003@umn.edu |
| Contact: Kathleen Kane, BS | 612-624-5721 | krkane@umn.edu |
| United States, Minnesota | |
| University of Minnesota Department of Dermatology | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Principal Investigator: Maria Hordinsky, MD | |
| Principal Investigator: | Maria Hordinsky, MD | University of Minnesota - Department of Dermatology |
More Information
No publications provided
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT01797432 History of Changes |
| Other Study ID Numbers: | 0907M69801 |
| Study First Received: | July 6, 2012 |
| Last Updated: | February 20, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alopecia Alopecia Areata Hypotrichosis Hair Diseases Skin Diseases Pathological Conditions, Anatomical Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Anti-Inflammatory Agents |
Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013