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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01797432
First received: July 6, 2012
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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 Intervention
Alopecia Areata
Drug: Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
Device: Restylane

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Change in alopecia areata half head severity score (AAHHSS) at 12 weeks compared to baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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. The primary analysis will be a comparison of means of AAHHSS between two treatments on the two sides of AA patients scalp using paired t-tests.


Secondary Outcome Measures:
  • Number of adverse events reported by subjects [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To assess the safety of IL triamcinolone acetonide10 mg/cc and Restylane® in the management of AA.


Estimated Enrollment: 10
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797432

Contacts
Contact: Katherine Wiens, MS 612-625-9338 wiens027@umn.edu

Locations
United States, Minnesota
University of Minnesota Department of Dermatology Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Maria Hordinsky, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Maria Hordinsky, MD University of Minnesota - Department of Dermatology
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01797432     History of Changes
Other Study ID Numbers: 0907M69801
Study First Received: July 6, 2012
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hair Diseases
Alopecia
Alopecia Areata
Hypotrichosis
Skin Diseases
Pathological Conditions, Anatomical
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014