Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Women
Condition: Cellulite; Edematous Fibrosclerotic Panniculopathy (EFP)
MeSH terms: Cellulite
Intervention: EN3835
Intervention description: Collagenase Clostridium Histolyticum (CCH)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a single center, open-label, Phase 2a study to assess the photonumeric scale,
      morphological, and histopathological changes associated with Collagenase Clostridium
      Histolyticum (CCH) in adult women with moderate or severe Edematous Fibrosclerotic
      Panniculopathy (EFP).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have both buttocks or both posterolateral thighs with:

               1. A score of 3 or 4 (moderate or severe) as reported by the investigator using the
                  Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS).

               2. A Hexsel Cellulite Severity Scale (CSS) Subsection A "Number of Evident
                  Depressions" score of >0, and Subsection B "Depth of Depressions" score of 2
                  )medium depth depression) or 3 (deep depressions)..

          2. Have a minimum of 2 well defined and isolated cellulite dimples.

          3. Be willing to apply sunscreen to the treatment area before each exposure to the sun
             for the duration of the study (from the Screening Visit through the Day 251/Early
             Termination Visit).

          4. Be judged to be in good health.

          5. Have a negative pregnancy test.

          6. 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 scar, 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. Requires anticoagulant or antiplatelet medication during the study.

          7. Has used or intends to use any of the local
             applications/therapies/injections/procedures that restricts study participation.

          8. Has used any form of artificial tanning (sprays, lotions, tanning booth, etc) within
             the 30 days prior to the first dose of study treatment or plans to use any form of
             artificial tanning during the study (through the Day 251/Early Termination Visit).

          9. Has a positive HIV test and/or a positive Hepatitis B surface antigen (HBsAg) or
             Hepatitis B core antibody (HBcAb) test at screening.

         10. Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg,
             KYBELLA®) or any similar treatment.

         11. Has a history of keloids, hypertrophied scars, and/or other complications following
             biopsy.

         12. Has any contraindications for MRI(implant containing metal, internal metallic object,
             permanent cosmetics/make-up, claustrophobia, syncope, low blood pressure, epilepsy,
             asthma, sickle cell disease) that restricts study participation.

         13. 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.

         14. Has previously received treatment with CCH in this clinical study.

         15. Has received treatment with an investigational product within 30 days (or 5
             half-lives, whichever is longer) of the Screening Visit.

         16. Is pregnant and/or is providing breast milk or plans to become pregnant and/or to
             provide breast milk during the course of the study.

         17. Has any other condition(s) that, in the investigator's opinion, might indicate the
             subject to be unsuitable for the study.