Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite
Condition: Edematous Fibrosclerotic Panniculopathy (EFP); Cellulite
MeSH terms: Cellulite; Contusions
Intervention: CCH-aaes; Compression; Cold Packs; Arnica Gel; INhance®; PDL
Intervention description: Participants were administered CCH-aaes by subcutaneous injection to both buttocks.; Participants used a compression garment on both buttocks following subcutaneous CCH-aaes injections.; Participants used cold packs applied to the right buttock for 5-10 minutes immediately after subcutaneous CCH-aaes injections.; Participants used Arnica Gel Patches (Arnica montana 50% and Ledum palustre) immediately after the CCH-aaes injection to the right buttock.; Participants used INhance Post-injection Serum topically immediately after the CCH-aaes injection to the right buttock.; Investigators applied one treatment with PDL to the right buttock between days 1-7 after injection.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bruising mitigation; CCH-aaes

Summary:

      This study will investigate treatments that may mitigate bruising after QWO™ (Collagenase
      clostridium histolyticum [CCH]-aaes) treatment of cellulite in the buttocks.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Have both buttocks with:

               1. Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) score of 3
                  (moderate) as reported by the Investigator, and

               2. Hexsel Cellulite Severity Scale (CSS) Subsection D "Grade of laxity, flaccidity,
                  or sagging skin" score of 0 (absence of laxity, flaccidity, or sagging skin) or 1
                  (slightly draped appearance).

          2. Have a body mass index between ≥18 and ≤30 kilograms (kg)/square meter (m^2).

          3. Be willing to apply sunscreen before each exposure to the sun while participating in
             the study (that is, Baseline through end of study).

          4. Be judged to be in good health.

          5. Be willing and able to cooperate with the requirements of the study.

        Key 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.