CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) +1 moredrug
Likely dose
Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10)from record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01797432
NCT01797432Phase 2Completed

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

University of Minnesota·interventional·Posted Feb 22, 2013·Updated Jan 12, 2021

In Brief

A Phase 2 clinical trial evaluating Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) and Restylane for Alopecia Areata. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlopecia Areata
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 22, 2013
Enrollment StartMar 1, 2009
Primary CompletionNov 1, 2014
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 13.4 years ago

Interventions

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

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

Restylanedevice

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