Effectiveness and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women (NCT03428750) | Clinical Trial Compass
CompletedPhase 3
Effectiveness and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women
United States423 participantsStarted 2018-02-05
Plain-language summary
Subjects will be screened for study eligibility within 14 days prior to enrolling in this study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of cellulite as independently assessed by the subject using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) and by the Investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) will be eligible. The eligibility of the buttocks will be confirmed on Day 1. Once the eligibility of the buttocks is confirmed, subjects will be randomly assigned to a treatment group (EN3835 0.84 mg per buttock or placebo) in a 1:1 ratio within an investigational site. Each subject will receive a treatment course which consists of up to 3 treatment visits (sessions), separated by 21 days (ie, Days 1, 22, and 43). Each treatment visit will consist of 12 injections (0.3 mL per injection of EN3835 0.07 mg/injection or placebo; 0.84 mg in 3.6 mL per buttock) in each of the two buttocks for a total volume of 7.2 mL (1.68 mg). Selection of dimples to be treated in the buttocks will be at the discretion of the Investigator. End of study will occur at study day 71.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Voluntarily sign and date an informed consent agreement
✓. Be a female ≥18 years of age
✓. At Screening visit, have 2 bilateral buttocks with each buttock having:
✓. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and
✓. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS)
✓. At Day 1 visit, have 2 bilateral buttocks with each buttock having:
✓. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and
✓. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS)
Exclusion criteria
✕. Has any of the following systemic conditions:
✕. Coagulation disorder
What they're measuring
1
2-level Composite Responders for the Target Buttock
. Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there has been no recurrence in at least 5 years
✕. History of keloidal scarring or abnormal wound healing
✕. Concurrent diseases or conditions that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. Any questions about concurrent diseases should be discussed with the Medical Monitor
✕. Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values
✕. Has any of the following local conditions in the areas to be treated:
✕. History of lower extremity thrombosis or post-thrombosis syndrome