CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques
Condition: Edematous Fibrosclerotic Panniculopathy; Cellulite; Laxity; Skin
MeSH terms: Cellulite
Intervention: collagenase clostridium histolyticum
Intervention description: Delivered via uniform grid injection techniques.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to investigate the safety and efficacy of collagenase clostridium
      histolyticum (CCH) for the treatment of mild to moderate edematous fibrosclerotic
      panniculopathy (cellulite) in participants with moderate to severe dermal laxity in the
      buttocks or thighs with comparison between two (2) different CCH injection techniques.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a body mass index of 18 to <29.9 kilograms/square meters

          2. Have either both buttocks or both posterolateral thighs with:

               1. Score of 2 or 3 (mild or moderate cellulite) as reported by the investigator
                  using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS)

               2. Hexsel Cellulite Severity Scale (CSS) Subsection D "Grade of Laxity, Flaccidity,
                  or Sagging Skin" score of 2 or 3 (moderate or severe) as determined by the
                  investigator

          3. Have a negative pregnancy test or be of non-childbearing potential

          4. Be willing and able to cooperate with the requirements of the study

          5. Be willing to apply sunscreen to the treatment areas before each exposure to the sun
             for the duration of the study (from the Screening Visit through the Day 180/Early
             Termination Visit).

        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.