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

2016-04-01 10:23:23 | BioPortfolio

Summary

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).

Study Design

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

Conditions

Edematous Fibrosclerotic Panniculopathy

Intervention

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM, Placebo Comparator

Location

Clinical Testing of Beverly Hills
Beverly Hills
California
United States
90210

Status

Recruiting

Source

Endo Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-04-01T10:23:23-0400

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

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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).

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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.

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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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