Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite

Exclusion Criteria

• •1. Has a coagulation disorder including but not limited to a Factor II, V, VII, or X deficiency.
• •2. Has local conditions in the areas to be treated (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
• •3. Has skin laxity or linear undulations on buttocks that can be effaced by lifting skin.
• •4. Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before CCH-aaes treatment.
• •1. Antiplatelet medication (clopidogrel \[Plavix®\] including aspirin at any dose within 14 days of treatment.
• •2. Anticoagulants, such as warfarin (Coumadin®); heparin analogues within 14 days of treatment.
• •3. Non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen (Motrin®, Advil®) and naproxen (Aleve®) 7 days before the study.
• •4. Any medications or food that have or have been reported to have anticoagulant effects within 14 days of treatment.
• •5. Antibiotics, such as penicillin and cephalosporin within 48 hours of treatment.
• •5. Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation.
• •6. Is pregnant and/or is presently nursing or providing breast milk or plans to become pregnant during the study.
• •7. Intends to initiate an intensive sport or exercise program during the study.
• •8. Tanning or use of tanning agents.
• •9. Intends to engage in strenuous activity within 48 hours after the first injection of CCH-aaes.
• •10. Has received an investigational drug or treatment within 30 days prior to injection of CCH-aaes.
• •11. Has a history of hypersensitivity or allergy to collagenase or any other excipient of CCH-aaes.
• •12. Has a known systemic allergy or local sensitivity to any of the mitigation treatments or including excipients (that is, arnica patches, INhance Post-injection Serum).
• •13. Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH-aaes in a previous investigational study for cellulite.
• •14. For participants allocated to PDL treatment Participants will be excluded from PDL treatment if they have any contraindications to PDL a. exposure to Accutane® (isotretinoin) within 6 months of CCH-aaes treatment.