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

NCT ID: NCT01797432

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2015-12-31

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.

Conditions

Alopecia Areata

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined IL Kenalog and Restylane

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp

Restylane

Intervention Type: DEVICE

Intralesional injections of 2mLs of Restylane on one side of the scalp

Interventions

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

Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp

Intervention Type: DRUG

Restylane

Intralesional injections of 2mLs of Restylane on one side of the scalp

Intervention Type: DEVICE

Other Intervention Names

Kenalog-10

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Hordinsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota - Department of Dermatology

Locations

University of Minnesota Department of Dermatology

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

0907M69801

Identifier Type: -

Identifier Source: org_study_id