Histopathology Following CCH Injection

Phase 2

Completed

• Conditions: Characteristics of Subcutaneous Tissue
• Interventions: Drug: Collagenase Clostridium Histolyticum Single Injection Technique; Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique

• Registration Number: NCT04236635
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-20
• Study First Submitted: 2020-01-02
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-22
• Primary Completion: 2020-09-23
• Study Completion: 2020-10-26
• Results First Submitted: 2021-09-23
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-17
• Last Update Submitted: 2022-03-17
• Results First Posted: 2022-04-12
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: CCH Single Injection Technique	Collagenase Clostridium Histolyticum 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.
Group 2: CCH Single Injection Technique	Collagenase Clostridium Histolyticum 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.
Group 3: CCH Single Injection Technique	Collagenase Clostridium Histolyticum 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.
Group 4: CCH Multiple Injection Technique	Collagenase Clostridium Histolyticum 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.
Group 5: CCH Multiple Injection Technique	Collagenase Clostridium Histolyticum 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.
Group 6: CCH Multiple Injection Technique	Collagenase Clostridium Histolyticum 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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH	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

Name	Time	Method
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	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.
Number of Participants With Anti-AUX-I and Anti-AUX-II Neutralizing Antibodies (NAbs) After CCH Treatment	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.
Number of Participants With Anti-AUX-I and Anti-AUX-II Anti-Drug Antibodies (ADAs) After CCH Treatment	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.

Trial Locations

Locations (2)

Endo Clinical Trial Site #1; 🇺🇸 Montclair, New Jersey, United States

Endo Clinical Trial Site #2; 🇺🇸 New York, New York, United States