Phase 2
N=10
Histopathology Following CCH Injection
Characteristics of Subcutaneous Tissue
Bottom Line
View on ClinicalTrials.gov: NCT04236635 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH — 2; 1; 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Collagenase Clostridium Histolyticum Single Injection Technique (Drug); Collagenase Clostridium Histolyticum Multiple Injection Technique (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Endo Pharmaceuticals
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH |
2; 1; 1; 2; 1; 1 | — |
| SECONDARY 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 |
2; 1; 1; 2; 1; 1 | — |
| SECONDARY Number of Participants With Anti-AUX-I and Anti-AUX-II Anti-Drug Antibodies (ADAs) After CCH Treatment |
9; 5 | — |
| SECONDARY Number of Participants With Anti-AUX-I and Anti-AUX-II Neutralizing Antibodies (NAbs) After CCH Treatment |
7; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Be adequately informed and understand the nature and risks of the study and be able to provide consent.
- Be undergoing planned elective abdominoplasty.
- Be willing to have their tissue donated for evaluation.
- Be judged to be in good health.
- Have a negative pregnancy test.
- Be willing and able to cooperate with the requirements of the study.
Exclusion Criteria
- 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).
- Has systemic conditions (coagulation disorders, malignancy, keloidal scar, abnormal wound healing) that restricts study participation.
- Has local (in the areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation.
- Required use of anticoagulant or antiplatelet medication (except ≤ 150 mg aspirin daily) before or during participation in the trial.
- Past history of any abdominal surgery, including but not limited to: liposuction, caesarean section, appendectomy, cholecystectomy, or umbilical hernia repair.
- Has used or intends to use any local applications/therapies/injections/procedures that restricts study participation.
- Is presently nursing or providing breast milk in any manner.
- Intends to become pregnant during the study.
- Intends to initiate an intensive sport or exercise program regimen during the study.
- Intends to use any tanning spray or tanning booths during the study.
- Has received any investigational drug or treatment within 30 days prior to first injection of study drug.
- Has a known systemic allergy to collagenase or any other excipient of study drug.
- Has received any collagenase treatment at any time prior to treatment in this study.
- Any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.
Data sourced from ClinicalTrials.gov (NCT04236635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.