Completed

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

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What is being tested

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

+ Restylane

DrugDevice
Who is being recruted

Alopecia+3

+ Hair Diseases

+ Hypotrichosis

Over 18 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2009
See protocol details

Summary

Principal SponsorUniversity of Minnesota
Last updated: January 12, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2009

Actual date on which the first participant was enrolled.

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.

NCT01797432
Principal SponsorUniversity of Minnesota
Last updated: January 12, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AlopeciaHair DiseasesHypotrichosisSkin DiseasesSkin and Connective Tissue DiseasesAlopecia Areata

Criteria

6 inclusion criteria required to participate
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
Men and women ages 18 and greater
Subjects are capable of giving informed consent
Willing to abstain from the use of non-steroidal anti-inflammatory medications, aspirin, St. Johns Wart, and high doses of Vitamin E supplementation
Show More Criteria
14 exclusion criteria prevent from participating
Allergy or intolerance to Restylane or hyaluronate preparations
Allergy or intolerance to triamcinolone acetonide, 10 mg/cc
Application of topical immunomodulatory or immunosuppressive agent in the preceding 6 weeks
Clinical evidence of secondary skin infection (i.e., folliculitis)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Minnesota Department of Dermatology

Minneapolis, United StatesOpen University of Minnesota Department of Dermatology in Google Maps
CompletedOne Study Center
Safety and Efficacy of Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata | PatLynk