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

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

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 Overview

• Status: Completed
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10); Device: Restylane

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined IL Kenalog and Restylane; Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp	Drug: Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10); Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp; Other Names: Kenalog-10; Device: Restylane; Intralesional injections of 2mLs of Restylane on one side of the scalp

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Maria Hordinsky, MD, University of Minnesota - Department of Dermatology

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 6, 2012
• First Submitted That Met QC Criteria: February 20, 2013
• First Posted (Estimate): February 22, 2013

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 0907M69801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No