Histopathology Following CCH Injection
Condition: Characteristics of Subcutaneous Tissue
Intervention: Collagenase Clostridium Histolyticum Single Injection Technique; Collagenase Clostridium Histolyticum Multiple Injection Technique
Intervention description: CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg.; CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the histopathology of subcutaneous tissue isolated after single or multiple
      Collagenase Clostridium Histolyticum (CCH) injection techniques in adult female participants
      undergoing abdominoplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be adequately informed and understand the nature and risks of the study and be able to
             provide consent.

          2. Be undergoing planned elective abdominoplasty.

          3. Be willing to have their tissue donated for evaluation.

          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 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 systemic conditions (coagulation disorders, malignancy, keloidal scar, abnormal
             wound healing) that restricts study participation.

          3. Has local (in the areas to be treated) conditions (thrombosis, vascular disorder,
             active infection/inflammation, active cutaneous alteration, tattoo/mole) that
             restricts study participation.

          4. Required use of anticoagulant or antiplatelet medication (except ≤ 150 mg aspirin
             daily) before or during participation in the trial.

          5. Past history of any abdominal surgery, including but not limited to: liposuction,
             caesarean section, appendectomy, cholecystectomy, or umbilical hernia repair.

          6. Has used or intends to use any local applications/therapies/injections/procedures that
             restricts study participation.

          7. Is presently nursing or providing breast milk in any manner.

          8. Intends to become pregnant during the study.

          9. Intends to initiate an intensive sport or exercise program regimen during the study.

         10. Intends to use any tanning spray or tanning booths during the study.

         11. Has received any investigational drug or treatment within 30 days prior to first
             injection of study drug.

         12. Has a known systemic allergy to collagenase or any other excipient of study drug.

         13. Has received any collagenase treatment at any time prior to treatment in this study.

         14. Any other condition(s) that, in the investigator's opinion, might indicate the subject
             to be unsuitable for the study.