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CompletedNCT04236635Updated Apr 12, 2022Results posted

Histopathology Following CCH Injection

A Phase 2 interventional study of Collagenase Clostridium Histolyticum Single Injection Technique and Collagenase Clostridium Histolyticum Multiple Injection Technique in Characteristics of Subcutaneous Tissue, sponsored by Endo Pharmaceuticals. Completed at 2 sites in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-12.

Sponsored by Endo Pharmaceuticals · Phase 2, Interventional, and Basic science

Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Characteristics of Subcutaneous Tissue
03

In context

Lead sponsor

Endo Pharmaceuticals is the lead sponsor of 100 studies on the registry; none are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • DrugCollagenase Clostridium Histolyticum Single Injection Technique

    CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg.

    Also known as: EN3835, CCH

  • DrugCollagenase Clostridium Histolyticum Multiple Injection Technique

    CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg.

    Also known as: EN3835, CCH

06

What researchers measure

Primary outcomes

  1. Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH

    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.

    Time frame: Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)

Secondary outcomes

  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

    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.

    Time frame: Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)

  2. Number of Participants With Anti-AUX-I and Anti-AUX-II Anti-Drug Antibodies (ADAs) After CCH Treatment

    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.

    Time frame: End of Study (Day 28)

  3. Number of Participants With Anti-AUX-I and Anti-AUX-II Neutralizing Antibodies (NAbs) After CCH Treatment

    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.

    Time frame: End of Study (Day 28)

07

Results

Posted Apr 12, 2022
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.

Participant flow

Participant flow — Overall Study
MilestoneGroup 1: Collagenase Clostridium Histolyticum (CCH) Single Injection TechniqueGroup 2: CCH Single Injection TechniqueGroup 3: CCH Single Injection TechniqueGroup 4: CCH Multiple Injection TechniqueGroup 5: CCH Multiple Injection TechniqueGroup 6: CCH Multiple Injection Technique
Started211411
Safety population211411
Evaluable population211211
Completed211411
Not completed000000

Outcome measures

PrimaryNumber of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH

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.

Time frame:
Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)
Reported as:
Count of participants · Participants
Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH
ParticipantsGroup 1: CCH Single Injection TechniqueGroup 2: CCH Single Injection TechniqueGroup 3: CCH Single Injection TechniqueGroup 4: CCH Multiple Injection TechniqueGroup 5: CCH Multiple Injection TechniqueGroup 6: CCH Multiple Injection Technique
Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH211211
SecondaryNumber 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

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.

Time frame:
Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)
Reported as:
Count of participants · 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
ParticipantsGroup 1: CCH Single Injection TechniqueGroup 2: CCH Single Injection TechniqueGroup 3: CCH Single Injection TechniqueGroup 4: CCH Multiple Injection TechniqueGroup 5: CCH Multiple Injection TechniqueGroup 6: CCH Multiple Injection Technique
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 Injection211211
SecondaryNumber of Participants With Anti-AUX-I and Anti-AUX-II Anti-Drug Antibodies (ADAs) After CCH Treatment

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.

Time frame:
End of Study (Day 28)
Reported as:
Count of participants · Participants
Number of Participants With Anti-AUX-I and Anti-AUX-II Anti-Drug Antibodies (ADAs) After CCH Treatment
ParticipantsCCH Subcutaneous Injection
Anti-AUX-I ADAs9
Anti-AUX-II ADAs5
SecondaryNumber of Participants With Anti-AUX-I and Anti-AUX-II Neutralizing Antibodies (NAbs) After CCH Treatment

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.

Time frame:
End of Study (Day 28)
Reported as:
Count of participants · Participants
Number of Participants With Anti-AUX-I and Anti-AUX-II Neutralizing Antibodies (NAbs) After CCH Treatment
ParticipantsCCH Subcutaneous Injection
Anti-AUX-I NAbs7
Anti-AUX-II NAbs3

Adverse events

Collected over From first injection (earliest dosing visit at Day -43) up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty) for CCH injection treatment and up to end of study (Day 28 post-abdominoplasty surgery follow-up visit). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: CCH Single Injection Technique0/2 (0%)0/2 (0%)2/2 (100%)
Group 2: CCH Single Injection Technique0/1 (0%)0/1 (0%)1/1 (100%)
Group 3: CCH Single Injection Technique0/1 (0%)0/1 (0%)1/1 (100%)
Group 4: CCH Multiple Injection Technique0/4 (0%)0/4 (0%)4/4 (100%)
Group 5: CCH Multiple Injection Technique0/1 (0%)0/1 (0%)1/1 (100%)
Group 6: CCH Multiple Injection Technique0/1 (0%)0/1 (0%)1/1 (100%)
Most frequent other events
Showing 10 of 17
Most frequent other events
EventGroup 1: CCH Single Injection TechniqueGroup 2: CCH Single Injection TechniqueGroup 3: CCH Single Injection TechniqueGroup 4: CCH Multiple Injection TechniqueGroup 5: CCH Multiple Injection TechniqueGroup 6: CCH Multiple Injection Technique
Injection site bruisingGeneral disorders1/21/11/13/40/10/1
Injection site painGeneral disorders2/20/10/14/41/11/1
Injection site haemorrhageGeneral disorders2/20/10/11/40/10/1
HypertensionVascular disorders1/20/10/10/40/11/1
Abdominal herniaGastrointestinal disorders0/21/10/11/40/11/1
HypoaesthesiaNervous system disorders1/21/11/14/41/11/1
Post procedural swellingInjury, poisoning and procedural complications1/21/10/10/41/10/1
Procedural painInjury, poisoning and procedural complications2/21/11/14/41/11/1
EcchymosisSkin and subcutaneous tissue disorders2/21/11/13/41/11/1
Postoperative wound infectionInjury, poisoning and procedural complications0/21/10/10/40/10/1

Baseline characteristics

Safety Population: All participants who received at least 1 injection of study drug irrespective of the timing window of abdominoplasty. Baseline characteristics (demographic) data were combined for all participants to protect personally identifiable information (PII) of the participant and to reduce risk of participant identification in the small population size of the 2 arms/groups.

Age, Continuous
Age, Continuous(years)CCH Subcutaneous Injection
Mean44.1 ± 10.55
Sex: Female, Male
Sex: Female, Male(Participants)CCH Subcutaneous Injection
Female10
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)CCH Subcutaneous Injection
Hispanic or Latino2
Not Hispanic or Latino8
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)CCH Subcutaneous Injection
American Indian or Alaska Native0
Asian4
Native Hawaiian or Other Pacific Islander0
Black or African American0
White5
More than one race0
Unknown or Not Reported1
Weight
Weight(Kg)CCH Subcutaneous Injection
Mean71.31 ± 16.275
Height
Height(cm)CCH Subcutaneous Injection
Mean164.47 ± 7.265
BMI
BMI(kg/m^2)CCH Subcutaneous Injection
Mean26.24 ± 4.460
08

Study locations

2 sites
  • Endo Clinical Trial Site #1
    Montclair, New Jersey 07042, United States
  • Endo Clinical Trial Site #2
    New York, New York 10021, United States
09

References and documents

Study documents

  • Study protocol · May 1, 2020
  • Statistical analysis plan · Jun 26, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04236635
Lead sponsor
Endo Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 22, 2020
Start date
Dec 20, 2019
Primary completion
Sep 23, 2020
Completion
Oct 26, 2020
Results posted
Apr 12, 2022
Last update
Apr 12, 2022

Study contacts

Karen Chajko
study director · Endo Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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