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

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797432
• Other study ID #: 0907M69801
• Status: Completed
• Phase: Phase 2
• Start date: March 2009
• Est. completion date: December 2015

Study information

• Verified date: December 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

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

Device:
• Restylane
Intralesional injections of 2mLs of Restylane on one side of the scalp

Locations

Country	Name	City	State
United States	University of Minnesota Department of Dermatology	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline	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. Four discreet areas of the scalp are examined. The percent of terminal hair loss in each area is measured by visual estimation. Those percent figures are multiplied by the total area on one half of the scalp represented by the four respective areas. 1) Left parietal scalp (18% of area), right parietal scalp (18% of area), frontal scalp (40% of area), and occipital scalp (24% of area). Scores range from 0 to 50, with higher scores indicating more hair loss.	12 weeks
Secondary	Number of Adverse Events Reported by Subjects	To assess the safety of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA.	12 weeks