Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata

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Brief Title

Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata

Official Title

Safety and Efficacy of Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata

Brief Summary

      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.
    



Study Type

Interventional


Primary Outcome

Change in alopecia areata half head severity score (AAHHSS) at 12 weeks compared to baseline

Secondary Outcome

 Number of adverse events reported by subjects

Condition

Alopecia Areata

Intervention

Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10)

Study Arms / Comparison Groups

 Combined IL Kenalog and Restylane
Description:  Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

March 2009

Completion Date

December 2015

Primary Completion Date

November 2014

Eligibility Criteria

        Inclusion Criteria:

          1. Men and women ages 18 and greater.

          2. 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.

          3. Willing to abstain from use of over the counter products and prescription products,
             other than study medications, which may promote hair growth.

          4. Willing to abstain from the use of non-steroidal anti-inflammatory medications,
             aspirin, St. Johns Wart, and high doses of Vitamin E supplementation.

          5. Subjects are capable of giving informed consent.

          6. Willing to adhere to protocol, including scalp examinations and photography.

        Exclusion Criteria:

          1. Allergy or intolerance to Restylane® or hyaluronate preparations

          2. Allergy or intolerance to triamcinolone acetonide, 10 mg/cc.

          3. Underlying disease that might be adversely affected by Restylane® or triamcinolone
             (ex. patients with bleeding disorders).

          4. Immunosuppressed patients (history of transplantation, cancer, chemotherapy,
             splenectomy, HIV).

          5. Pregnant or lactating female.

          6. Application of topical immunomodulatory or immunosuppressive agent in the preceding 6
             weeks.

          7. 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.

          8. Clinical evidence of secondary skin infection (i.e., folliculitis).

          9. Other inflammatory or infectious skin disease that might interfere with evaluations
             during the study.

         10. Investigational medications within the past 30 days.

         11. Patients with susceptibility to keloid formation.

         12. Severe allergies manifested by a history of anaphylaxis, or history or presence of
             multiple severe allergies

         13. Patients with allergies to gram positive bacterial proteins

         14. Unable to give consent.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Maria Hordinsky, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01797432

Organization ID

0907M69801


Responsible Party

Sponsor

Study Sponsor

University of Minnesota


Study Sponsor

Maria Hordinsky, MD, Principal Investigator, University of Minnesota - Department of Dermatology


Verification Date

March 2016