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

2014-09-26 15:08:32 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Edematous Fibrosclerotic Panniculopathy (EFP)

Intervention

Collagenase Clostridium Histolyticum, Placebo

Location

Dermatology Cosmetic Laser Medical Associates of La Jolla
San Diego
California
United States
92121

Status

Completed

Source

Auxilium Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-09-26T15:08:32-0400

Clinical Trials [158 Associated Clinical Trials listed on BioPortfolio]

EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

The study will evaluate the safety, effectiveness, and immunogenicity of EN3835 in the treatment of adult women with Edematous Fibrosclerotic Panniculopathy (Commonly known as Cellulite).

EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).

Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP

This study will evaluate the safety and Pharmacokinetics (PK) of a single 3.36-mg dose of Collagenase Clostridium Histolyticum (CCH) in 4 quadrants concurrently, in subjects with Edematous...

Injection Techniques of EN3835 for the Treatment of EFP (Commonly Known as Cellulite)

The study will evaluate the safety and effectiveness of different injection techniques of EN3835 for the treatment of adult women with mild, moderate or severe Edematous Fibrosclerotic Pan...

Safety and Effectiveness of EN3835 in the Treatment of EFP in Women

An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women.

PubMed Articles [1255 Associated PubMed Articles listed on BioPortfolio]

Predictors of treatment success after Collagenase clostridium histolyticum injection for Peyronie's disease. Development of a nomogram from a multicentre single-arm, non-placebo controlled clinical study.

To build-up a nomogram able to predict treatment success after Collagenase clostridium histolyticum (CCH) for Peyronie's disease (PD).

Plaque calcification: An important predictor of collagenase clostridium histolyticum treatment outcomes for men with Peyronie's Disease.

To compare outcomes of men with or without calcified plaques undergoing collagenase clostridium histolyticum (CCH) injections for Peyronie's Disease (PD) and identify predictors of CCH success.

Multi-institutional prospective analysis of intralesional injection of Collagenase Clostridium Histolyticum, tunical plication and partial plaque excision and grafting for the management of Peyronie's disease.

To compare in a prospective, non-randomized fashion the outcomes of Collagenase Clostridium Histolyticum (CCH) and surgical interventions (tunical plication [TP] and partial plaque excision and grafti...

Percutaneous Needle Fasciotomy Versus Collagenase Treatment for Dupuytren Contracture: A Randomized Controlled Trial with a Two-Year Follow-up.

Local disruption of the cord that causes contracture of the finger in Dupuytren disease can be achieved either through mechanical division by percutaneous needle fasciotomy (PNF) or through enzymatic ...

Limited success with clostridium collagenase histolyticum following FDA approval for the treatment of Peyronie's disease.

Collagenase clostridium histolyticum (CCH) was approved for the treatment of Peyronie's disease (PD) in December of 2013. Recently, further research has supported its use. The aim of this study was to...

Medical and Biotech [MESH] Definitions

A species of gram-positive, strongly proteolytic bacteria in the family Clostridiaceae. It contains several forms of COLLAGENASE whose action can lead to GAS GANGRENE in humans and HORSES.

A metalloproteinase which degrades helical regions of native collagen to small fragments. Preferred cleavage is -Gly in the sequence -Pro-Xaa-Gly-Pro-. Six forms (or 2 classes) have been isolated from Clostridium histolyticum that are immunologically cross-reactive but possess different sequences and different specificities. Other variants have been isolated from Bacillus cereus, Empedobacter collagenolyticum, Pseudomonas marinoglutinosa, and species of Vibrio and Streptomyces. EC 3.4.24.3.

A severe condition resulting from bacteria invading healthy muscle from adjacent traumatized muscle or soft tissue. The infection originates in a wound contaminated with bacteria of the genus CLOSTRIDIUM. C. perfringens accounts for the majority of cases (over eighty percent), while C. noyvi, C. septicum, and C. histolyticum cause most of the other cases.

Type species of the genus CLOSTRIDIUM, a gram-positive bacteria in the family Clostridiaceae. It is used as a source of PROBIOTICS.

Infections with bacteria of the genus CLOSTRIDIUM.

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