A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of EN3835 In The Treatment Of Edematous Fibrosclerotic Panniculopathy (Cellulite)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Edematous Fibrosclerotic Panniculopathy (Cellulite)
- Sponsor
- Endo Pharmaceuticals
- Enrollment
- 422
- Locations
- 25
- Primary Endpoint
- 2-level Composite Responders for the Target Buttock
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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)
- •Be willing to apply sunscreen to the buttocks before each exposure to the sun while participating in the study (ie, Screening through end of study)
- •Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at Screening
Exclusion Criteria
- •Has any of the following systemic conditions:
- •Coagulation disorder
- •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
- •Vascular disorder (eg, varicose veins, telangiectasia) in area to be treated
- •Inflammation or active infection
Outcomes
Primary Outcomes
2-level Composite Responders for the Target Buttock
Time Frame: Day 71
Proportion of 2-level Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) / Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) composite responders in the target buttock at Day 71. CR-PCSS and PR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is defined as a participant with improvement from baseline of at least 2-levels of severity in the CR-PCSS and an improvement from baseline of at least 2-levels of severity in the PR-PCSS of the target buttock. A participant who missed one or two assessments of CR-PCSS and PR-PCSS at Day 71 was defined as a non-responder.
Secondary Outcomes
- 2-level Composite Responders of the Non-target Buttock(Day 71)
- 2-level PR-PCSS Responders of the Target Buttock(Day 71)
- 1-level Composite Responders of the Target Buttock(Day 71)
- 1-level S-GAIS Responders of Target Buttock(Day 71)
- 1-level PR-PCSS Responders of the Target Buttock(Day 71)
- Subjects Satisfaction With Cellulite Treatment(Day 71)
- 2-level S-GAIS Responders of Target Buttock(Day 71)
- 1-level SSRS Responders(Day 71)
- Change From Baseline in PR-CIS Total Score(Day 71)
- PR-PCSS Rating for the Target and Non-target Buttock by Visit(Day 71)