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Histopathology Following CCH Injection

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ClinicalTrials.gov Identifier: NCT04236635
Recruitment Status : Completed
First Posted : January 22, 2020
Results First Posted : April 12, 2022
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Characteristics of Subcutaneous Tissue Drug: Collagenase Clostridium Histolyticum Single Injection Technique Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 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
Actual Primary Completion Date : September 23, 2020
Actual Study Completion Date : October 26, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: CCH Single Injection Technique

Participants were administered 0.07 milligrams (mg) CCH subcutaneously using a single injection technique.

Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14.

Drug: Collagenase Clostridium Histolyticum Single Injection Technique
CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg.
Other Names:
  • EN3835
  • CCH

Experimental: Group 2: CCH Single Injection Technique
Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.
Drug: Collagenase Clostridium Histolyticum Single Injection Technique
CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg.
Other Names:
  • EN3835
  • CCH

Experimental: Group 3: CCH Single Injection Technique
Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.
Drug: Collagenase Clostridium Histolyticum Single Injection Technique
CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg.
Other Names:
  • EN3835
  • CCH

Experimental: Group 4: CCH Multiple Injection Technique

Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.

Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14.

Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique
CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg.
Other Names:
  • EN3835
  • CCH

Experimental: Group 5: CCH Multiple Injection Technique

Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.

Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.

Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique
CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg.
Other Names:
  • EN3835
  • CCH

Experimental: Group 6: CCH Multiple Injection Technique

Participants were administered 0.0653 mg CCH subcutaneously using a multiple injection technique.

Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -22 and -1. Area 2 was administered CCH on Day -1.

Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique
CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg.
Other Names:
  • EN3835
  • CCH




Primary Outcome Measures :
  1. Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH [ Time Frame: Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty) ]
    Tissue specimens isolated from participants undergoing an abdominoplasty procedure were observed for histopathological structure changes of tissues post treatment with CCH. The number of participants with a histologic change (as determined by the pathologist) in tissue dosed with CCH relative to control tissue (tissue not dosed with CCH) is reported.


Secondary Outcome Measures :
  1. Number of Participants With a Histologic Change in a Tissue Specimen After 2 CCH Dose Injections Relative to a Tissue Specimen After 1 CCH Dose Injection [ Time Frame: Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty) ]
    Tissue specimens isolated from participants undergoing an abdominoplasty procedure were observed for histopathological structure changes of tissues post treatment with CCH. The number of participants with a histologic change (as determined by the pathologist) in a tissue specimen injected with 2 CCH dose injections (Treatment Area 1) relative to 1 CCH dose injection (Treatment Area 2) is reported.

  2. Number of Participants With Anti-AUX-I and Anti-AUX-II Anti-Drug Antibodies (ADAs) After CCH Treatment [ Time Frame: End of Study (Day 28) ]
    Serum samples were analyzed for anti-AUX-I clostridial class I collagenase of ADAs and anti-AUX-II Clostridial class II collagenase of ADAs. The number of participants who developed anti-AUX-I and anti-AUX-II ADAs (positive ADA result) are reported.

  3. Number of Participants With Anti-AUX-I and Anti-AUX-II Neutralizing Antibodies (NAbs) After CCH Treatment [ Time Frame: End of Study (Day 28) ]
    Serum samples were analyzed for anti-AUX-I and Anti-AUX-II Nabs. The number of participants who developed anti-AUX-I and Anti-AUX-II NAbs (positive NAb results) are reported. Neutralizing antibodies were only tested from ADA positive participants.



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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.
  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.

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


Locations
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United States, New Jersey
Endo Clinical Trial Site #1
Montclair, New Jersey, United States, 07042
United States, New York
Endo Clinical Trial Site #2
New York, New York, United States, 10021
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Karen Chajko Endo Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Endo Pharmaceuticals:
Study Protocol  [PDF] May 1, 2020
Statistical Analysis Plan  [PDF] June 26, 2020

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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
Results First Posted: April 12, 2022
Last Update Posted: April 12, 2022
Last Verified: March 2022
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