Status:
COMPLETED
Effectiveness and Safety of EN3835 in the Treatment of Cellulite in Women
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Edematous Fibrosclerotic Panniculopathy (Cellulite)
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 ind...
Eligibility Criteria
Inclusion
- 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
- Have a negative serum pregnancy test at Screening and a negative urine pregnancy test before injection of study drug and be using a stable and effective contraception method (eg, abstinence, intrauterine device \[IUD\], hormonal \[estrogen/progestin\] contraceptives, or double barrier method) for at least 1 menstrual cycle prior to study enrollment and for the duration of the study; or be menopausal defined as 12 months of amenorrhea in the absence of other biological or physiological causes, as determined by the Investigator; or post-menopausal for at least 1 year; or be surgically sterile
- Be willing and able to cooperate with the requirements of the study
- Be able to read, complete and understand the patient-reported outcomes rating instruments in English
Exclusion
- 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
- Severe skin laxity, flaccidity, and/or sagging
- Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer
- Has a tattoo and/or a mole located within 2 cm of the site of injection
- Requires the following concomitant medications before or during participation in the trial:
- a. Anticoagulant or antiplatelet medication or has received anticoagulant or antiplatelet medication (except for ≤150 mg aspirin daily) within 7 days before injection of study drug
- Has used any of the following for the treatment of EFP on a buttock within the timelines identified below or intends to use any of the following at any time during the course of the study:
- Liposuction in a buttock during the 12-month period before injection of study drug
- Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; buttock implant treatment; cryolipolysis; or surgery (including subcision and/or powered subcision) within a buttock during the 12-month period before injection of study drug
- Any investigational treatment for EFP on a buttock during the 12-month period before the injection of study drug
- Endermologie or similar treatments within a buttock during the 6-month period before injection of study drug
- Massage therapy within a buttock during the 3-month period before injection of study drug
- Creams (eg, Celluvera™, TriLastin®) and/or home therapies to prevent or mitigate EFP within a buttock during the 2-week period before injection of study drug
- Is presently nursing or providing breast milk
- Intends to become pregnant during the study
- Intends to initiate an intensive sport or exercise program during the study
- Intends to initiate a weight reduction program during the study
- Intends to use tanning spray or tanning booths during the study
- Has received an investigational drug or treatment within 30 days before injection of study drug
- Has a known systemic allergy to collagenase or any other excipient of study drug
- Has received any collagenase treatments at any time prior to treatment
- Was a subject in a previous cellulite clinical trial of CCH: AUX-CC-830, AUX-CC-831, EN3835-102, EN3835-104, EN3835-201, EN3835-202, and/or EN3835-205
- Any other condition(s) that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study
Key Trial Info
Start Date :
February 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2018
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT03446781
Start Date
February 8 2018
End Date
September 26 2018
Last Update
October 8 2020
Active Locations (25)
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1
Endo Clinical Trial Site #1
Glendale, Arizona, United States, 85308
2
Endo Clinical Trial Site #2
North Little Rock, Arkansas, United States, 72116
3
Endo Clinical Trial Site #3
Beverly Hills, California, United States, 90210
4
Endo Clinical Trial Site #4
Murrieta, California, United States, 92562