Effectiveness and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women

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
• 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 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
• 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