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

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ClinicalTrials.gov Identifier: NCT01797432
Recruitment Status : Completed
First Posted : February 22, 2013
Results First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) Device: Restylane Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
Study Start Date : March 2009
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2015

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 Name: Kenalog-10

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

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797432

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United States, Minnesota
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
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Principal Investigator: Maria Hordinsky, MD University of Minnesota - Department of Dermatology
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Informed Consent Form  [PDF] November 17, 2014

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01797432    
Other Study ID Numbers: 0907M69801
First Posted: February 22, 2013    Key Record Dates
Results First Posted: January 12, 2021
Last Update Posted: January 12, 2021
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action