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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.
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Edematous Fibrosclerotic Panniculopathy (EFP)
Collagenase Clostridium Histolyticum, Placebo
Dermatology Cosmetic Laser Medical Associates of La Jolla
Published on BioPortfolio: 2014-09-26T15:08:32-0400
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).
A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).
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...
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...
An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women.
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).
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.
Dupuytren's contracture produces a progressive flexion contracture of the affected fingers. Collagenase Clostridium histolyticum produces breakdown of the cord in the hand and/or finger(s) that tighte...
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...
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 ...
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 126.96.36.199.
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.
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...