Status:
COMPLETED
Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
Lead Sponsor:
University of Minnesota
Conditions:
Alopecia Areata
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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, gi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01797432
Start Date
March 1 2009
End Date
December 1 2015
Last Update
January 12 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, United States, 55455