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Histopathology Following CCH Injection

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ClinicalTrials.gov Identifier: NCT04236635
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 2, 2020
First Posted Date  ICMJE January 22, 2020
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE December 20, 2019
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2020)
Histopathology before and after CCH treatment compared to control tissue (tissue not administered with CCH) [ Time Frame: Approximately 3 months ]
Histopathology of removed tissue defined by the observation and analysis of the removed specimen by a trained Pathologist
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Histopathology Following CCH Injection
Official Title  ICMJE A Phase 2B, Open-Label Study to Explore Tissue Histopathology Following Subcutaneous Injection of Collagenase Clostridium Histolyticum Using An Abdominoplasty Model
Brief Summary To evaluate the histopathology of subcutaneous tissue isolated after single or multiple Collagenase Clostridium Histolyticum (CCH) injection techniques in adult female subjects undergoing abdominoplasty.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Characteristics of Subcutaneous Tissue
Intervention  ICMJE Drug: EN3835
Collagenase Clostridium Histolyticum (CCH)
Study Arms  ICMJE
  • Experimental: Single CCH Subcutaneous Injection Technique
    Approximately 0.07mg EN3835 (Collagenase Clostridium Histolyticum) in each injection.
    Intervention: Drug: EN3835
  • Experimental: Multiple CCH Subcutaneous Injection Technique
    Approximately 0.07mg EN3835 (Collagenase Clostridium Histolyticum) in each injection.
    Intervention: Drug: EN3835
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2020)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 and research.
  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) 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.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Erin Brown 800-462-3636 ClinicalTrials@Endo.com
Contact: Davina Cupo 800-462-3636 ClinicalTrials@Endo.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04236635
Other Study ID Numbers  ICMJE EN3835-213
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Responsible Party Endo Pharmaceuticals
Study Sponsor  ICMJE Endo Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Saji Vijayan, MD Endo Pharmaceuticals
PRS Account Endo Pharmaceuticals
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP