Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alopecia Areata
Intervention: Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) (Drug); Restylane (Device)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Minnesota - Clinical and Translational Science Institute Official(s) and/or principal investigator(s): Maria Hordinsky, MD, Principal Investigator, Affiliation: University of Minnesota - Department of Dermatology
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.
Clinical Details
Official title: Safety and Efficacy of Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University of Minnesota Department of Dermatology, Minneapolis, Minnesota 55455, United States
Additional Information
Starting date: March 2009
Last updated: July 15, 2015
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