Real World CCH Study in Adult Females With Cellulite
Condition: Edematous Fibrosclerotic Panniculopathy (EFP); Cellulite
MeSH terms: Cellulite
Intervention: EN3835
Intervention description: Collagenase Clostridium Histolyticum (CCH)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the
      safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic
      panniculopathy (EFP).

      Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the
      posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or
      moderate EFP in the buttocks.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have both buttocks or both posterolateral thighs with:

               1. A score of 2 or 3 (mild or moderate) as reported by the investigator using the
                  Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).

               2. A 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) at the Screening Visit only.

          2. Be willing to apply sunscreen to the treatment areas before each exposure to the sun
             for the duration of the study.

          3. Be judged to be in good health.

          4. Have a negative pregnancy test.

          5. Be willing and able to cooperate with the requirements of the study.

        Exclusion Criteria:

          1. Is from a vulnerable population, as defined by the United States (US) Code of Federal
             Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national
             regulations, including but not limited to, 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).

          2. Has a history of sensitivity or allergy to collagenase or any other excipient of CCH.

          3. Has systemic conditions (coagulation disorders, malignancy, keloidal scarring,
             abnormal wound healing) that restricts study participation.

          4. Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active
             infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study
             participation.

          5. Has skin laxity or linear undulations on the treatment region (both buttocks or both
             thighs) that can be effaced by lifting skin.

          6. Has a Hexsel CSS Subsection D "Grade of laxity, flaccidity, or sagging skin" of 2
             (moderate draped appearance) or 3 (severe draped appearance).

          7. Requires anticoagulant or antiplatelet medication during the study.

          8. Has used or intends to use any of the local
             applications/therapies/injections/procedures that restricts study participation.

          9. Has received any collagenase treatments at any time prior to treatment in this study
             and/or has received previous treatment with EN3835 or CCH for cellulite.

         10. Has received treatment with an investigational product within 30 days (or 5
             half-lives, whichever is longer) of the Screening Visit.

         11. Is pregnant and/or is providing breast milk in any manner, or plans to become pregnant
             and/or to provide breast milk during the course of the study.

         12. Has any other condition(s) that, in the investigator's opinion, might indicate the
             subject to be unsuitable for the study.