drugset
drugset / Trial / NCT01518907

The Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

NCT01518907 ↗

Phase 1 Completed 99 enrolled Endo USA Inc., a Keenova Therapeutics Company
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the safety, effectiveness, pharmacokinetics, and immunogenicity of AA4500 at increasing doses and concentrations in the treatment of adult women with cellulite.

Timeline

Start
2012-01
Primary completion
2012-12
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic 0.0029 mg Other
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic 0.0145 mg Other
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic 0.0435 mg Other
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic 0.116 mg Other
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic 0.232 mg Other
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic 0.464 mg Other

Indications

cellulitis panniculitis and localized lipodystrophy