An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
158
During 3 treatment visits 12 injections will be given per treatment area
Endo Clinical Trial Site #1
Scottsdale, Arizona, United States
Endo Clinical Trial Site #2
Huntington Beach, California, United States
Endo Clinical Trial Site #3
San Diego, California, United States
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders
Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 2-levels of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from "0" (None) to "4" (Severe). A 2-level responder is a participant with a reduction in severity of at least 2-levels from Baseline at that particular visit. Number of participants analyzed is determined by observed participants at each visit.
Time frame: Day 22, 43, 90, and 180
Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders
Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 1-level of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from "0" (None) to "4" (Severe). A 1-level responder is a participant with a reduction in severity of at least 1-level from Baseline at that particular visit. Percentages are based on the observed counts. Number of participants analyzed is determined by observed participants at each visit.
Time frame: Day 22, 43, 90, and 180
Subject Satisfaction With Cellulite Treatment Assessment at End of Study
At Day 180, participants rated their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings range from Very Satisfied with Treatment (2), Satisfied with Treatment (1), Neither Dissatisfied nor Satisfied with Treatment (0), Dissatisfied with Treatment (-1), and Very Dissatisfied with Treatment (-2). Percentages are based on the observed counts.
Time frame: Day 180
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Endo Clinical Trial Site #4
Santa Monica, California, United States
Endo Clinical Trial Site #5
Coral Gables, Florida, United States
Endo Clinical Trial Site #6
Tampa, Florida, United States
Endo Clinical Trial Site #7
West Palm Beach, Florida, United States
Endo Clinical Trial Site #8
Alpharetta, Georgia, United States
Endo Clinical Trial Site #9
New York, New York, United States
Endo Clinical Trial Site #10
Franklin, Tennessee, United States
...and 1 more locations