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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).
An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women.
The purpose of this study is to assess the efficacy of clostridium histolyticum collagenase (XIAFLEX®) in treating urethral strictures.
To evaluate the effect of collagenase clostridium histolyticum treatment at the Department of Orthopaedic surgery at Horsens Regional Hospital after minimum one-year follow-up (FU).
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...
The aim of this meta-analysis was to assess the safety and efficacy of collagenase clostridium histolyticum compared with fasciectomy and percutaneous needle fasciotomy (PNF) for Dupuytren's disease.
The collagenase produced by a gram-negative bacterium Grimontia hollisae strain 1706B (Ghcol) degrades collagen more efficiently than that produced by a gram-positive bacterium Clostridium histolyticu...
Three newly discovered H2 producing bacteria namely Clostridium perfringens strain JJC, Clostridium bifermentans strain WYM and Clostridium sp. strain Ade.TY originated from landfill leachate sludge h...
Clostridium difficile is a leading cause of nosocomial infection. The role of cytokine IL-27 in the immunopathology of Clostridium difficile infection (CDI) remains unknown.
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 184.108.40.206.
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...