Characteristics of Subcutaneous TissuePhase 2NCT04236635
Histopathology Following CCH Injection
A Phase 2 study testing Collagenase Clostridium Histolyticum Single Injection Technique and Collagenase Clostridium Histolyticum Multiple Injection Technique in people with Characteristics of Subcutaneous Tissue, run by Endo USA Inc., a Keenova Therapeutics Company at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Characteristics of Subcutaneous Tissue
- What is being tested?
- Collagenase Clostridium Histolyticum Single Injection Technique and Collagenase Clostridium Histolyticum Multiple Injection Technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Dec 2019to 26 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Endo Clinical Trial Site #1
Montclair, New Jersey, 07042
Endo Clinical Trial Site #2
New York, New York, 10021
About this study
Official title: A Phase 2B, Open-Label Study to Explore Tissue Histopathology Following Subcutaneous Injection of Collagenase Clostridium Histolyticum Using An Abdominoplasty Model
To evaluate the histopathology of subcutaneous tissue isolated after single or multiple Collagenase Clostridium Histolyticum (CCH) injection techniques in adult female participants undergoing abdominoplasty.
- Conditions
- Characteristics of Subcutaneous Tissue
- Being tested
- Collagenase Clostridium Histolyticum Single Injection Technique, Collagenase Clostridium Histolyticum Multiple Injection Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagenase Clostridium Histolyticum Single Injection TechniqueDrug
Also called EN3835, CCH
CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg.
Collagenase Clostridium Histolyticum Multiple Injection TechniqueDrug
Also called EN3835, CCH
CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: CCH Single Injection Technique | Experimental | 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. Receives: Drug: Collagenase Clostridium Histolyticum Single Injection Technique |
| Group 2: CCH Single Injection Technique | Experimental | 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. Receives: Drug: Collagenase Clostridium Histolyticum Single Injection Technique |
| Group 3: CCH Single Injection Technique | Experimental | 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. Receives: Drug: Collagenase Clostridium Histolyticum Single Injection Technique |
| Group 4: CCH Multiple Injection Technique | Experimental | 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. Receives: Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique |
| Group 5: CCH Multiple Injection Technique | Experimental | 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. Receives: Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique |
| Group 6: CCH Multiple Injection Technique | Experimental | 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. Receives: Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)
Secondary outcomes (3)
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.
Measured: Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)
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.
Measured: End of Study (Day 28)
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.
Measured: End of Study (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start20 Dec 2019
- Primary completion23 Sep 2020
- Study completion26 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Characteristics of Subcutaneous TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Chajko, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236635
- Sponsor's protocol ID
- EN3835-213
- Status last verified
- Mar 2022
- First submitted
- 2 Jan 2020
- Last updated
- 12 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2B, Open-Label Study to Explore Tissue Histopathology Following Subcutaneous Injection of Collagenase Clostridium Histolyticum Using An Abdominoplasty Model
- ClinicalTrials.gov ID
- NCT04236635
- Acronym / sponsor ID
- EN3835-213
- Conditions
- Characteristics of Subcutaneous Tissue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Posted 12 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the histopathology of subcutaneous tissue isolated after single or multiple Collagenase Clostridium Histolyticum (CCH) injection techniques in adult female participants undergoing abdominoplasty.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: CCH Single Injection Technique | Experimental | Drug: Collagenase Clostridium Histolyticum Single Injection TechniqueParticipants 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 | Experimental | Drug: Collagenase Clostridium Histolyticum Single Injection TechniqueParticipants 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 | Experimental | Drug: Collagenase Clostridium Histolyticum Single Injection TechniqueParticipants 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 | Experimental | Drug: Collagenase Clostridium Histolyticum Multiple Injection TechniqueParticipants 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 | Experimental | Drug: Collagenase Clostridium Histolyticum Multiple Injection TechniqueParticipants 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 | Experimental | Drug: Collagenase Clostridium Histolyticum Multiple Injection TechniqueParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagenase Clostridium Histolyticum Single Injection TechniqueAlso: EN3835, CCHCCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg. | Drug | Group 1: CCH Single Injection Technique, Group 2: CCH Single Injection Technique, Group 3: CCH Single Injection Technique |
| Collagenase Clostridium Histolyticum Multiple Injection TechniqueAlso: EN3835, CCHCCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg. | Drug | Group 4: CCH Multiple Injection Technique, Group 5: CCH Multiple Injection Technique, Group 6: CCH Multiple Injection Technique |
Primary outcome
Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH
Time frame: 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.
3 secondary outcomes
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
Time frame: Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)
Number of Participants With Anti-AUX-I and Anti-AUX-II Anti-Drug Antibodies (ADAs) After CCH Treatment
Time frame: End of Study (Day 28)
Number of Participants With Anti-AUX-I and Anti-AUX-II Neutralizing Antibodies (NAbs) After CCH Treatment
Time frame: End of Study (Day 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Chajko study director
Endo USA Inc., a Keenova Therapeutics Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Collagenase Clostridium Histolyticum Single Injection Technique and Collagenase Clostridium Histolyticum Multiple Injection Technique in people with Characteristics of Subcutaneous Tissue, run by Endo USA Inc., a Keenova Therapeutics Company at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH (time frame: Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.