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

Edematous Fibrosclerotic Panniculopathy (EFP) Clinical Trial

Official title: A Phase 2, Double-blind and Placebo Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy

Status Completed

Clinical Trial 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.

Clinical Trial Description

The Phase 2a study is a randomized, double-blind multiple-dose study that is expected to enroll approximately 144 women between the ages of 18 and 45 in the United States. Treatment effectiveness will be evaluated by investigator and patient assessments, as well as 3-D photographic imaging techniques. Once the safety and local tolerability profile from the first stage has been found to be acceptable subjects will be enrolled in stage 2. After an interim safety and local tolerability review was completed of all subjects in stage 1, it was determined that enrollment in stage 2 is acceptable and has been initiated. ;

Related Conditions & MeSH terms

• Edema
• Edematous Fibrosclerotic Panniculopathy (EFP)

• NCT number: NCT01987986
• Study type: Interventional
• Source: Endo Pharmaceuticals
• Status: Completed
• Phase: Phase 2
• Start date: October 2013
• Completion date: August 2014