CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques

Exclusion Criteria

• •1. Has a history of hypersensitivity or allergy to collagenase or any other excipients of CCH.
• •2. During Screening has a CR-PCSS score of less than 2 or greater than 3 for the area to be treated (buttocks or thighs) and/or has a Hexsel CSS Subsection D "Grade of Laxity, Flaccidity, or Sagging Skin" score of less than 2 or greater than 3 (severe) for the areas to be treated (buttocks or thighs).
• •3. Has a coagulation disorder, which requires anticoagulant or antiplatelet medication during the study (except for ≤150 mg aspirin daily), or has taken anticoagulant or antiplatelet medication(s) within 14 days before injection of study treatment (except for ≤150 mg aspirin daily).
• •4. Is a prisoner, an individual with impaired decision making capacity, employees (temporary, part-time, full-time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC), or in the judgment of the investigator the participant is disadvantaged and vulnerable to coercion due to lack of education, or due to poor economic circumstances.
• •5. Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH in a previous investigational study for cellulite.
• •6. Is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study.
• •7. Has a history of scarring due to keloids or abnormal wound healing.
• •8. Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation
• •9. Has history of drug or alcohol abuse within the 5 years prior to the Screening Visit.
• •10. Has evidence of clinically significant abnormalities, as judged by the investigator, in any of the following: physical examination findings, electrocardiogram (ECG), clinical laboratory values, or vital signs.
• •The sponsor's medical monitor will be required to review the results for confirmation of eligibility in the case of any of the following: abnormalities in electrocardiograms indicating corrected QT interval (QTc) prolongation of 470 milliseconds or greater; and clinical laboratory values of liver enzymes
• •11. Has used or intends to use any of the local application/therapies/injections/procedures that restricts study participation.
• •12. Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
• •13. For the subset of participants participating in the collection of ultrasound data, the following exclusions will apply: participants will be excluded who have: a history of a spinal laminectomy, a previous history or presence of vascular abnormalities (for example, deep vein thrombosis, thrombophlebitis), a healing fracture, an impaired sensation within, or near, the planned treatment area, or any implants within, or near, the planned treatment area.