Effectiveness and Safety of EN3835 in the Treatment of Cellulite in Women

Launched by ENDO PHARMACEUTICALS · Feb 23, 2018

Keywords

ClinConnect Summary

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Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily sign and date an informed consent agreement
• • 2. Be a female ≥18 years of age
• 3. At Screening visit, have 2 bilateral buttocks with each buttock having:
• • 1. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and
• • 2. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS)
• 4. At Day 1 visit, have 2 bilateral buttocks with each buttock having:
• • 1. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and
• • 2. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS)
• • 5. 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)
• • 6. Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at Screening
• • 7. 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
• • 8. Be willing and able to cooperate with the requirements of the study
• • 9. Be able to read, complete and understand the patient-reported outcomes rating instruments in English
• Exclusion Criteria:
• 1. Has any of the following systemic conditions:
• • 1. Coagulation disorder
• • 2. Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there has been no recurrence in at least 5 years
• • 3. History of keloidal scarring or abnormal wound healing
• • 4. 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
• • 5. Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values
• 2. Has any of the following local conditions in the areas to be treated:
• • 1. History of lower extremity thrombosis or post-thrombosis syndrome
• • 2. Vascular disorder (eg, varicose veins, telangiectasia) in area to be treated
• • 3. Inflammation or active infection
• • 4. Severe skin laxity, flaccidity, and/or sagging
• • 5. Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer
• • 6. Has a tattoo and/or a mole located within 2 cm of the site of injection
• 3. 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
• 4. 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:
• • 1. Liposuction in a buttock during the 12-month period before injection of study drug
• • 2. 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
• • 3. Any investigational treatment for EFP on a buttock during the 12-month period before the injection of study drug
• • 4. Endermologie or similar treatments within a buttock during the 6-month period before injection of study drug
• • 5. Massage therapy within a buttock during the 3-month period before injection of study drug
• • 6. 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
• • 5. Is presently nursing or providing breast milk
• • 6. Intends to become pregnant during the study
• • 7. Intends to initiate an intensive sport or exercise program during the study
• • 8. Intends to initiate a weight reduction program during the study
• • 9. Intends to use tanning spray or tanning booths during the study
• • 10. Has received an investigational drug or treatment within 30 days before injection of study drug
• • 11. Has a known systemic allergy to collagenase or any other excipient of study drug
• • 12. Has received any collagenase treatments at any time prior to treatment
• • 13. 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
• • 14. Any other condition(s) that, in the Investigator's opinion, might indicate the subject to be unsuitable for the study