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Completed

NCT Number: NCT01797432

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota Department of Dermatology

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Drug

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

Other names: Kenalog-10

Restylane

Device

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

Primary outcomes

  1. Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Number of Adverse Events Reported by Subjects

    Time frame: 12 weeks

    To assess the safety of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Feb 22, 2013
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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