NCT01518907

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

A Phase 1b, Open-label, Dose-escalation Study of the Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy Commonly Known as Cellulite

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: Female
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Edematous Fibrosclerotic Panniculopathy
• Cellulite

Interventions

Type	Name	Description
BIOLOGICAL	COLLAGENASE CLOSTRIDIUM HISTOLYTICUM	Subdermal dose

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-12-01
• Completion: 2013-02-01
• First posted: 2012-01-26
• Last updated: 2015-03-19

Locations

1 site across 1 country: United States