NCT01797432|CompletedPhase 2ResultsDMCFDA Drug
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Safety and Efficacy of Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
Sponsor study identifier
interventional
14
1 country
1
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2014
Actual (reported)Study Completion
December 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
July 6, 2012
Actual (reported)February 22, 2013
Actual (reported)November 2014
Actual (reported)December 2015
Actual (reported)January 12, 2021
Actual (reported)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.
12 weeks
Number of Adverse Events Reported by Subjects
12 weeks
Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp
Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp
Intralesional injections of 2mLs of Restylane on one side of the scalp
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, 55455, United States
Maria Hordinsky, MD
University of Minnesota - Department of Dermatology
14 participants (actual enrollment reported by the registry).
First Submitted
July 6, 2012
First Posted
February 22, 2013
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
November 2014
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
January 12, 2021
Results First Posted
January 12, 2021
Record last verified: 2020-12
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Source: ClinicalTrials.gov.
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