NCT01797432

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10)	Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp
DEVICE	Restylane	Intralesional injections of 2mLs of Restylane on one side of the scalp

Timeline

• Start date: 2009-03-01
• Primary completion: 2014-11-01
• Completion: 2015-12-01
• First posted: 2013-02-22
• Last updated: 2021-01-12
• Results posted: 2021-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study