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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
injectible intervention
Dermatology Cosmetic Laser Medical Associates of La Jolla
San Diego, California, United States
ATS Clinical Research
Santa Monica, California, United States
Dermatology Research Institute
Coral Gables, Florida, United States
Investigator Global Assessment of Aesthetic Improvement
Investigators assessment of aesthetic improvement (I-GAIS) scores ranged from 3 to -1 as follows: 3 (very much improved), 2 (much improved), 1 (improved), 0 (no change), -1 (worse).
Time frame: Baseline, Day 73
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Kenneth Beer, MD PA
West Palm Beach, Florida, United States
Mercy Health Research
Washington, Missouri, United States
Sadick Research Group
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Charlottesville Dermatology
Charlottesville, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States