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Histopathology Following CCH Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Characteristics of Subcutaneous Tissue Drug: EN3835 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 2B, Open-Label Study to Explore Tissue Histopathology Following Subcutaneous Injection of Collagenase Clostridium Histolyticum Using An Abdominoplasty Model
Actual Study Start Date : December 20, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Single CCH Subcutaneous Injection Technique
Approximately 0.07mg EN3835 (Collagenase Clostridium Histolyticum) in each injection.
 Drug: EN3835
Collagenase Clostridium Histolyticum (CCH)
Experimental: Multiple CCH Subcutaneous Injection Technique
Approximately 0.07mg EN3835 (Collagenase Clostridium Histolyticum) in each injection.
 Drug: EN3835
Collagenase Clostridium Histolyticum (CCH)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236635


Contacts
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Contact: Erin Brown 800-462-3636 ClinicalTrials@Endo.com
Contact: Davina Cupo 800-462-3636 ClinicalTrials@Endo.com

Locations
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United States, New Jersey
Endo Clinical Trial Site #1 Recruiting
Montclair, New Jersey, United States, 07042
United States, New York
Endo Clinical Trial Site #2 Recruiting
New York, New York, United States, 10021
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Saji Vijayan, MD Endo Pharmaceuticals
More Information
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04236635    
Other Study ID Numbers: EN3835-213
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No