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

NCT01797432 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 0907M69801
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Adverse Events Reported by Subjects

  12 weeks

Study Arms (1)

Combined IL Kenalog and Restylane

EXPERIMENTAL

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); Device: Restylane

Interventions

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

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

Also known as: Kenalog-10

Combined IL Kenalog and Restylane

Restylane DEVICE

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

Combined IL Kenalog and Restylane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Department of Dermatology

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Maria Hordinsky, MD
• Organization: University of Minnesota

hordi001@umn.edu

612-625-6118

Study Officials

• Maria Hordinsky, MD

  University of Minnesota - Department of Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: February 22, 2013
• Study Start: March 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2015
• Last Updated: January 12, 2021
• Results First Posted: January 12, 2021

Record last verified: 2020-12

Locations

US (1)