Trial · NCT04236635
Histopathology Following CCH Injection
NCT04236635, Phase 2, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2022-04-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Histopathology Following CCH Injection. Trials, record NCT04236635. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04236635
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Histopathology Following CCH Injection
- NCT number
- NCT04236635
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Characteristics of Subcutaneous Tissue
- Interventions
- Collagenase Clostridium Histolyticum Single Injection Technique, Collagenase Clostridium Histolyticum Multiple Injection Technique
- First posted
- 2020-01-22
- Last updated
- 2022-04-12
- Results first posted
- 2022-04-12
- Limitations and caveats
This was considered an exploratory study by the Sponsor. No formal sample size calculations were performed. Completion of 8 participants provided minimal data to meet the primary objective in the evaluable population.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | Evaluable Population: All participants who received at least 1 injection of study drug, underwent abdominoplasty within the protocol specified timelines, and had a histopathology and immunohistochemistry report. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty) | Evaluable Population: All participants who received at least 1 injection of study drug, underwent abdominoplasty within the protocol specified timelines, and had a histopathology and immunohistochemistry report. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Anti-AUX-I and Anti-AUX-II Anti-Drug Antibodies (ADAs) After CCH Treatment | End of Study (Day 28) | Safety Population: All participants who received at least 1 injection of study drug irrespective of the timing window of abdominoplasty. ADA data is reported as overall population instead of individual groups due to the small number of participants per arm and to protect PII of the participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Anti-AUX-I and Anti-AUX-II Neutralizing Antibodies (NAbs) After CCH Treatment | End of Study (Day 28) | All participants who received at least 1 injection of study drug and were positive for ADAs. NAb data is reported as overall analysis population instead of individual groups due to the small number of participants per arm and to protect PII of the participants. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH | Group 1: CCH Single Injection Technique | 2 | Participants | ||
| Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH | Group 2: CCH Single Injection Technique | 1 | Participants | ||
| Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH | Group 3: CCH Single Injection Technique | 1 | Participants | ||
| Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH | Group 4: CCH Multiple Injection Technique | 2 | Participants | ||
| Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH | Group 5: CCH Multiple Injection Technique | 1 | Participants | ||
| Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH | Group 6: CCH Multiple Injection Technique | 1 | Participants | ||
| 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 | Group 1: CCH Single Injection Technique | 2 | Participants | ||
| 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 | Group 2: CCH Single Injection Technique | 1 | Participants | ||
| 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 | Group 3: CCH Single Injection Technique | 1 | Participants | ||
| 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 | Group 4: CCH Multiple Injection Technique | 2 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Collagenase Clostridium Histolyticum (CCH) Single Injection Technique | 2 | |
| Overall Study | STARTED | Group 2: CCH Single Injection Technique | 1 | |
| Overall Study | STARTED | Group 3: CCH Single Injection Technique | 1 | |
| Overall Study | STARTED | Group 4: CCH Multiple Injection Technique | 4 | |
| Overall Study | STARTED | Group 5: CCH Multiple Injection Technique | 1 | |
| Overall Study | STARTED | Group 6: CCH Multiple Injection Technique | 1 | |
| Overall Study | Safety Population | Group 1: Collagenase Clostridium Histolyticum (CCH) Single Injection Technique | 2 | |
| Overall Study | Safety Population | Group 2: CCH Single Injection Technique | 1 | |
| Overall Study | Safety Population | Group 3: CCH Single Injection Technique | 1 | |
| Overall Study | Safety Population | Group 4: CCH Multiple Injection Technique | 4 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events102
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site oedema | General disorders | Group 1: CCH Single Injection Technique | 0 | 2 | |
| other | Injection site oedema | General disorders | Group 2: CCH Single Injection Technique | 0 | 1 | |
| other | Injection site oedema | General disorders | Group 3: CCH Single Injection Technique | 0 | 1 | |
| other | Injection site oedema | General disorders | Group 4: CCH Multiple Injection Technique | 2 | 4 | |
| other | Injection site oedema | General disorders | Group 5: CCH Multiple Injection Technique | 0 | 1 | |
| other | Injection site oedema | General disorders | Group 6: CCH Multiple Injection Technique | 0 | 1 | |
| other | Injection site bruising | General disorders | Group 1: CCH Single Injection Technique | 1 | 2 | |
| other | Injection site bruising | General disorders | Group 2: CCH Single Injection Technique | 1 | 1 | |
| other | Injection site bruising | General disorders | Group 3: CCH Single Injection Technique | 1 | 1 | |
| other | Injection site bruising | General disorders | Group 4: CCH Multiple Injection Technique | 3 | 4 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: CCH Single Injection Technique | 0 | 2 |
| Total, all-cause mortality | Group 2: CCH Single Injection Technique | 0 | 1 |
| Total, all-cause mortality | Group 3: CCH Single Injection Technique | 0 | 1 |
| Total, all-cause mortality | Group 4: CCH Multiple Injection Technique | 0 | 4 |
| Total, all-cause mortality | Group 5: CCH Multiple Injection Technique | 0 | 1 |
| Total, all-cause mortality | Group 6: CCH Multiple Injection Technique | 0 | 1 |
| Total, other adverse events | Group 1: CCH Single Injection Technique | 2 | 2 |
| Total, other adverse events | Group 2: CCH Single Injection Technique | 1 | 1 |
| Total, other adverse events | Group 3: CCH Single Injection Technique | 1 | 1 |
| Total, other adverse events | Group 4: CCH Multiple Injection Technique | 4 | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04236635
GET https://conductscience.org/api/trials/v1/NCT04236635/flow?page=2