Histopathology Following CCH Injection

Endo Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Characteristics of Subcutaneous Tissue

Treatments: Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique; Drug: Collagenase Clostridium Histolyticum Single Injection Technique

Study type: Interventional

Funder types: Industry

Identifiers

NCT04236635

EN3835-213

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 6 patient groups

Group 1: CCH Single Injection Technique

Experimental group

Description:

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.

Treatment:

Drug: Collagenase Clostridium Histolyticum Single Injection Technique

Group 2: CCH Single Injection Technique

Experimental group

Description:

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.

Treatment:

Drug: Collagenase Clostridium Histolyticum Single Injection Technique

Group 3: CCH Single Injection Technique

Experimental group

Description:

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.

Treatment:

Drug: Collagenase Clostridium Histolyticum Single Injection Technique

Group 4: CCH Multiple Injection Technique

Experimental group

Description:

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.

Treatment:

Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique

Group 5: CCH Multiple Injection Technique

Experimental group

Description:

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.

Treatment:

Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique

Group 6: CCH Multiple Injection Technique

Experimental group

Description:

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.

Treatment:

Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique