Back to resultsCombined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
Primary Purpose
Alopecia Areata
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
Restylane
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia Areata
Eligibility Criteria
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.
Sites / Locations
- University of Minnesota Department of Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Combined IL Kenalog and Restylane
Arm Description
Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Adverse Events Reported by Subjects
To assess the safety of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA.
Full Information
NCT ID
NCT01797432
First Posted
July 6, 2012
Last Updated
December 17, 2020
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01797432
Brief Title
Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
Official Title
Safety and Efficacy of Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combined IL Kenalog and Restylane
Arm Type
Experimental
Arm Description
Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp
Intervention Type
Drug
Intervention Name(s)
Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
Other Intervention Name(s)
Kenalog-10
Intervention Description
Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp
Intervention Type
Device
Intervention Name(s)
Restylane
Intervention Description
Intralesional injections of 2mLs of Restylane on one side of the scalp
Primary Outcome Measure Information:
Title
Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Adverse Events Reported by Subjects
Description
To assess the safety of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Hordinsky, MD
Organizational Affiliation
University of Minnesota - Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Department of Dermatology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
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