drugset
drugset / Trial / NCT01987986

A Phase 2, Randomized, Double-blind, Placebo Controlled Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy

NCT01987986 ↗

Phase 2 Completed 150 enrolled Endo USA Inc., a Keenova Therapeutics Company
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To assess the safety and effectiveness of repeat doses of AA4500 in the treatment of edematous fibrosclerotic panniculopathy (EFP) commonly known as cellulite in adult women.

Timeline

Start
2013-10
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic 0.06 mg —
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic 0.48 mg —
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic 0.84 mg —

Indications

panniculitis and localized lipodystrophy