A Phase 2 interventional study of CCH-aaes and Antifibrinolytic Agent in Edematous Fibrosclerotic Panniculopathy and Cellulite, sponsored by Endo Pharmaceuticals. Completed at 13 sites in United States. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by Endo Pharmaceuticals (part of Keenova Therapeutics plc) · Phase 2, Interventional, and Treatment
The study will evaluate the effect of different doses, strengths (concentrations), diluent additives, depths of injection, and methods of injection on the severity of bruising potentially induced by QWO (collagenase clostridium histolyticum-aaes [CCH-aaes]).
The study will comprise a Screening Period (28 days), Treatment Period (90 days), and Follow-up Period (90 days). Participants will receive CCH-aaes in different doses, concentrations, diluent additives, depths of injection, and methods of injection in a split buttock arrangement, with the right buttock serving as the control, and the left buttock (investigational side) receiving a study intervention.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 91 is above the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →Endo Pharmaceuticals is the lead sponsor of 99 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.
First submitted before Endo Pharmaceuticals became part of Keenova Therapeutics plc.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
In addition to the applicable aforementioned exclusion criteria, participants enrolling in Cohort 7 will be excluded from study participation if the participant:
Has any of the following medical conditions:
Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before CCH-aaes treatment:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be administered CCH-aaes at different doses. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
Drug: CCH-aaes
Participants will be administered CCH-aaes at different concentrations. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
Drug: CCH-aaes
Participants will be administered CCH-aaes using different injection depths. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
Drug: CCH-aaes
Participants will be administered CCH-aaes using different injection methods. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
Drug: CCH-aaes
Participants will be administered CCH-aaes and diluent additive. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
Drug: CCH-aaes
Participants will be administered CCH-aaes using a different treatment schedule and different doses and concentrations. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
Drug: CCH-aaes
Participants will be administered CCH-aaes and an antifibrinolytic agent. Participants will receive CCH-aaes treatments in a split buttock arrangement, with the right buttock as the control, and the left buttock as the investigational treatment.
Drug: CCH-aaes · Drug: Antifibrinolytic Agent
Administered by subcutaneous injection.
Also known as: Collagenase clostridium histolyticum-aaes, QWO®
Self-administered by participants enrolled in Cohort 7.
Percentage of Participants With at Least 1-Level Lower Score 3 to 5 Days After Initial CCH-aaes Injection, as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection
The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcomes. The investigator compared the bruising of the left (test) buttock to the right (control) buttock. Responders were participants whose left buttock/test side demonstrated at least a 1-level lower IABSS score versus the right buttock/control side. Percentages are based on the number of participants with an assessment at specified timepoint.
Time frame: 3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control)
Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS
The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome. The investigator compared the bruising of the left buttock (test) to the right (control) buttock. Responders were participants whose left buttock/test side at Visit A demonstrated at least a 1-level lower IABSS score versus the right buttock/control side at Visit B, where Visit A and B could either be the same or different. Follow-up after first injection is presented: Follow-up 1 is 1 to 2 days after injection visit, Follow-up 2 is 3 to 5 days after injection visit, Follow-up 3 is 6 to 9 days after injection visit, and Follow-up 4 is 10 to 14 days after injection visit. Percentages are based on the number of participants with an assessment at specified timepoint.
Time frame: Follow-up 1, 2, 3, and 4 after CCH-aaes injection of left buttock (test) and right buttock (control)
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
The investigator determined the degree of improvement of each buttock by comparing treated cellulite dimples from the Day 1 pre-treatment (Baseline) digital image of each buttock to the treated dimples observed in a live assessment. The investigator determined the degree of improvement of each buttock with the I-GAIS, which uses a 7-point scale ranging from +3 (very much improved) to -3 (very much worse). A higher score indicated a better outcome. The investigator compared the bruising of the left (test) buttock to the right (control) buttock. A 1-level I-GAIS responder was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at an analysis visit for that treatment area. Percentages are based on the number of participants with an assessment at specified timepoint.
Time frame: Day 22 and Day 43 for Cohorts 1 to 5, Day 43 for Cohort 6, Day 22, Day 43, and Day 64 for Cohort 7, and Day 90, Day 135, and Day 180 for all cohorts
Percentage of Participants With Injection Site Reactions
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that occur or worsen (increase in severity) on the same day or after the study intervention administration on Day 1. Percent of participants with TEAEs of injection site reactions are presented by left buttock (test) and right buttock (control). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: From Day 1 (after dose) through Day 180
| Milestone | Cohort 1: CCH-aaes Dose Evaluation | Cohort 2: CCH-aaes Concentration Evaluation | Cohort 3: CCH-aaes Injection Depth Evaluation | Cohort 4: CCH-aaes Injection Method Evaluation | Cohort 5: CCH-aaes and Diluent Additive Evaluation | Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Cohort 7b: CCH-aaes and Antifibrinolytic Agent |
|---|---|---|---|---|---|---|---|---|
| Started | 22 | 14 | 5 | 7 | 10 | 19 | 7 | 7 |
| Completed | 19 | 11 | 5 | 6 | 9 | 17 | 6 | 6 |
| Not completed | 3 | 3 | 0 | 1 | 1 | 2 | 1 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 2 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 2 | 1 | 0 | 0 | 1 | 2 | 0 | 1 |
The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcomes. The investigator compared the bruising of the left (test) buttock to the right (control) buttock. Responders were participants whose left buttock/test side demonstrated at least a 1-level lower IABSS score versus the right buttock/control side. Percentages are based on the number of participants with an assessment at specified timepoint.
| percentage of participants | Cohort 1: CCH-aaes Dose Evaluation | Cohort 2: CCH-aaes Concentration Evaluation | Cohort 3: CCH-aaes Injection Depth Evaluation | Cohort 4: CCH-aaes Injection Method Evaluation | Cohort 5: CCH-aaes and Diluent Additive Evaluation | Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Cohort 7b: CCH-aaes and Antifibrinolytic Agent |
|---|---|---|---|---|---|---|---|---|
| Percentage of Participants With at Least 1-Level Lower Score 3 to 5 Days After Initial CCH-aaes Injection, as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection | 90.5 (69.62 to 98.83) | 25.0 (5.49 to 57.19) | 20.0 (0.51 to 71.64) | 33.3 (4.33 to 77.72) | 44.4 (13.70 to 78.80) | 63.2 (38.36 to 83.71) | 33.3 (4.33 to 77.72) | 33.3 (4.33 to 77.72) |
The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome. The investigator compared the bruising of the left buttock (test) to the right (control) buttock. Responders were participants whose left buttock/test side at Visit A demonstrated at least a 1-level lower IABSS score versus the right buttock/control side at Visit B, where Visit A and B could either be the same or different. Follow-up after first injection is presented: Follow-up 1 is 1 to 2 days after injection visit, Follow-up 2 is 3 to 5 days after injection visit, Follow-up 3 is 6 to 9 days after injection visit, and Follow-up 4 is 10 to 14 days after injection visit. Percentages are based on the number of participants with an assessment at specified timepoint.
| percentage of participants | Cohort 1: CCH-aaes Dose Evaluation | Cohort 2: CCH-aaes Concentration Evaluation | Cohort 3: CCH-aaes Injection Depth Evaluation | Cohort 4: CCH-aaes Injection Method Evaluation | Cohort 5: CCH-aaes and Diluent Additive Evaluation | Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Cohort 7b: CCH-aaes and Antifibrinolytic Agent |
|---|---|---|---|---|---|---|---|---|
| Follow-up 1 | 81.8 (59.72 to 94.81) | 15.4 (1.92 to 45.45) | 0 (0 to 52.18) | 42.9 (9.90 to 81.59) | 40.0 (12.16 to 73.76) | 44.4 (21.53 to 69.24) | 16.7 (0.42 to 64.12) | 42.9 (9.90 to 81.59) |
| Follow-up 2 | 90.5 (69.62 to 98.83) | 25.0 (5.49 to 57.19) | 20.0 (0.51 to 71.64) | 33.3 (4.33 to 77.72) | 44.4 (13.70 to 78.80) | 63.2 (38.36 to 83.71) | 33.3 (4.33 to 77.72) | 33.3 (4.33 to 77.72) |
| Follow-up 3 | 40.9 (20.71 to 63.65) | 38.5 (13.86 to 68.42) | 40.0 (5.27 to 85.34) | 28.6 (3.67 to 70.96) | 10.0 (0.25 to 44.50) | 31.6 (12.58 to 56.55) | 40.0 (5.27 to 85.34) | 42.9 (9.90 to 81.59) |
| Follow-up 4 | 13.6 (2.91 to 34.91) | 18.2 (2.28 to 51.78) | 0 (0 to 52.18) | 14.3 (0.36 to 57.87) | 10.0 (0.25 to 44.50) | 21.1 (6.05 to 45.57) | 16.7 (0.42 to 64.12) | 71.4 (29.04 to 96.33) |
The investigator determined the degree of improvement of each buttock by comparing treated cellulite dimples from the Day 1 pre-treatment (Baseline) digital image of each buttock to the treated dimples observed in a live assessment. The investigator determined the degree of improvement of each buttock with the I-GAIS, which uses a 7-point scale ranging from +3 (very much improved) to -3 (very much worse). A higher score indicated a better outcome. The investigator compared the bruising of the left (test) buttock to the right (control) buttock. A 1-level I-GAIS responder was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at an analysis visit for that treatment area. Percentages are based on the number of participants with an assessment at specified timepoint.
| percentage of participants | Cohort 1: CCH-aaes Dose Evaluation | Cohort 2: CCH-aaes Concentration Evaluation | Cohort 3: CCH-aaes Injection Depth Evaluation | Cohort 4: CCH-aaes Injection Method Evaluation | Cohort 5: CCH-aaes and Diluent Additive Evaluation | Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Cohort 7b: CCH-aaes and Antifibrinolytic Agent |
|---|---|---|---|---|---|---|---|---|
| Day 22 Left Buttock (Test) | 42.9 (21.82 to 65.98) | 58.3 (27.67 to 84.83) | 100 (47.82 to 100) | 66.7 (22.28 to 95.67) | 40.0 (12.16 to 73.76) | — | 85.7 (42.13 to 99.64) | — |
| Day 22 Right Buttock (Control) | 57.1 (34.02 to 78.18) | 66.7 (34.89 to 90.08) | 100 (47.82 to 100) | 66.7 (22.28 to 95.67) | 40.0 (12.16 to 73.76) | — | — | 100 (59.04 to 100) |
| Day 43 Left Buttock (Test) | 71.4 (47.82 to 88.72) | 84.6 (54.55 to 98.08) | 100 (47.82 to 100) | 83.3 (35.88 to 99.58) | 66.7 (29.93 to 92.51) | 44.4 (21.53 to 69.24) | 100 (47.82 to 100) | 100 (59.04 to 100) |
| Day 43 Right Buttock (Control) | 76.2 (52.83 to 91.78) | 76.9 (46.19 to 94.96) | 100 (47.82 to 100) | 100 (54.07 to 100) | 66.7 (29.93 to 92.51) | 50.0 (26.02 to 73.98) | 40.0 (5.27 to 85.34) | 100 (59.94 to 100) |
| Day 64 Left Buttock (Test) | — | — | — | — | — | — | 100 (47.82 to 100) | 100 (59.04 to 100) |
| Day 64 Right Buttock (Control) | — | — | — | — | — | — | 100 (47.82 to 100) | 100 (59.04 to 100) |
| Day 90 (Follow-up) Left Buttock (Test) | 38.1 (18.11 to 61.56) | 70.0 (34.75 to 93.33) | 100 (47.82 to 100) | 66.7 (22.8 to 95.67) | 44.4 (13.70 to 78.80) | 27.8 (9.69 to 53.48) | 85.7 (42.13 to 99.64) | 100 (59.04 to 100) |
| Day 90 (Follow-up) Right Buttock (Control) | 47.6 (25.71 to 70.22) | 80.0 (44.39 to 97.48) | 100 (47.82 to 100) | 83.3 (35.88 to 99.58) | 44.4 (13.70 to 78.80) | 38.9 (17.30 to 64.25) | 71.4 (29.04 to 96.33) | 100 (59.04 to 100) |
| Day 135 (Follow-up) Left Buttock (Test) | 36.8 (16.29 to 61.64) | 90.9 (58.72 to 99.77) | 100 (47.82 to 100) | 50.0 (11.81 to 88.19) | 22.2 (2.81 to 60.01) | 22.2 (6.41 to 47.64) | 83.3 (35.88 to 99.58) | 100 (54.07 to 100) |
| Day 135 (Follow-up) Right Buttock (Control) | 47.4 (24.45 to 71.14) | 81.8 (48.22 to 97.72) | 100 (47.82 to 100) | 66.7 (22.28 to 95.67) | 22.2 (2.81 to 60.01) | 33.3 (13.34 to 59.01) | 66.7 (22.28 to 95.67) | 83.3 (35.88 to 99.58) |
| Day 180 (End of Study) Left Buttock (Test) | 36.8 (16.29 to 61.64) | 100 (71.51 to 100) | 100 (47.82 to 100) | 50.0 (11.81 to 88.19) | 11.1 (0.28 to 48.25) | 17.6 (3.80 to 43.43) | 66.7 (22.28 to 95.67) | 83.3 (35.88 to 99.58) |
| Day 180 (End of Study) Right Buttock (Control) | 36.8 (16.29 to 61.64) | 81.8 (48.22 to 97.72) | 100 (47.82 to 100) | 66.7 (22.28 to 95.67) | 11.1 (0.28 to 48.25) | 41.2 (18.44 to 67.08) | 66.7 (22.28 to 95.67) | 83.3 (35.88 to 99.58) |
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that occur or worsen (increase in severity) on the same day or after the study intervention administration on Day 1. Percent of participants with TEAEs of injection site reactions are presented by left buttock (test) and right buttock (control). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
| percentage of participants | Cohort 1: CCH-aaes Dose Evaluation | Cohort 2: CCH-aaes Concentration Evaluation | Cohort 3: CCH-aaes Injection Depth Evaluation | Cohort 4: CCH-aaes Injection Method Evaluation | Cohort 5: CCH-aaes and Diluent Additive Evaluation | Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Cohort 7b: CCH-aaes and Antifibrinolytic Agent |
|---|---|---|---|---|---|---|---|---|
| Left Buttock (Test) | 100 (84.56 to 100) | 92.9 (75.29 to 100) | 100 (47.82 to 100) | 100 (59.04 to 100) | 100 (69.15 to 100) | 100 (82.35 to 100) | 100 (59.04 to 100) | 100 (59.04 to 100) |
| Right Buttock (Control) | 100 (84.56 to 100) | 92.9 (75.29 to 100) | 100 (47.82 to 100) | 100 (59.04 to 100) | 100 (69.15 to 100) | 100 (82.35 to 100) | 85.7 (54.07 to 100) | 100 (59.04 to 100) |
Collected over From Day 1 (after dose) through Day 180. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: CCH-aaes Dose Evaluation-Test (ISR) | — | — | 22/22 (100%) |
| Cohort 1: CCH-aaes Dose Evaluation-Control (ISR) | — | — | 22/22 (100%) |
| Cohort 2: CCH-aaes Concentration Evaluation-Test (ISR) | — | — | 13/14 (92.9%) |
| Cohort 2: CCH-aaes Concentration Evaluation -Control (ISR) | — | — | 13/14 (92.9%) |
| Cohort 3: CCH-aaes Injection Depth Evaluation-Test (ISR) | — | — | 5/5 (100%) |
| Cohort 3: CCH-aaes Injection Depth Evaluation-Control (ISR) | — | — | 5/5 (100%) |
| Cohort 4: CCH-aaes Injection Method Evaluation-Test (ISR) | — | — | 7/7 (100%) |
| Cohort 4: CCH-aaes Injection Method Evaluation-Control (ISR) | — | — | 7/7 (100%) |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation-Test (ISR) | — | — | 10/10 (100%) |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation-Control (ISR) | — | — | 10/10 (100%) |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation -Test (ISR) | — | — | 19/19 (100%) |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation-Control (ISR) | — | — | 19/19 (100%) |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Test (ISR) | — | — | 7/7 (100%) |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Control (ISR) | — | — | 6/7 (85.7%) |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Test (ISR) | — | — | 7/7 (100%) |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Control (ISR) | — | — | 7/7 (100%) |
| Cohort 1: Systemic/Non-ISR AEs | 0/22 (0%) | 0/22 (0%) | 4/22 (18.2%) |
| Cohort 2: Systemic/Non-ISR AEs | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Cohort 3: Systemic/Non-ISR AEs | 0/5 (0%) | 0/5 (0%) | 3/5 (60%) |
| Cohort 4: Systemic/Non-ISR AEs | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Cohort 5: Systemic/Non-ISR AEs | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Cohort 6: Systemic/Non-ISR AEs | 0/19 (0%) | 0/19 (0%) | 4/19 (21.1%) |
| Cohort 7a: Systemic/Non-ISR AEs | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Cohort 7b: Systemic/Non-ISR AEs | 0/7 (0%) | 0/7 (0%) | 2/7 (28.6%) |
| Event | Cohort 1: CCH-aaes Dose Evaluation-Test (ISR) | Cohort 1: CCH-aaes Dose Evaluation-Control (ISR) | Cohort 2: CCH-aaes Concentration Evaluation-Test (ISR) | Cohort 2: CCH-aaes Concentration Evaluation -Control (ISR) | Cohort 3: CCH-aaes Injection Depth Evaluation-Test (ISR) | Cohort 3: CCH-aaes Injection Depth Evaluation-Control (ISR) | Cohort 4: CCH-aaes Injection Method Evaluation-Test (ISR) | Cohort 4: CCH-aaes Injection Method Evaluation-Control (ISR) | Cohort 5: CCH-aaes and Diluent Additive Evaluation-Test (ISR) | Cohort 5: CCH-aaes and Diluent Additive Evaluation-Control (ISR) | Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation -Test (ISR) | Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation-Control (ISR) | Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Test (ISR) | Cohort 7a: CCH-aaes and Antifibrinolytic Agent-Control (ISR) | Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Test (ISR) | Cohort 7b: CCH-aaes and Antifibrinolytic Agent-Control (ISR) | Cohort 1: Systemic/Non-ISR AEs | Cohort 2: Systemic/Non-ISR AEs | Cohort 3: Systemic/Non-ISR AEs | Cohort 4: Systemic/Non-ISR AEs | Cohort 5: Systemic/Non-ISR AEs | Cohort 6: Systemic/Non-ISR AEs | Cohort 7a: Systemic/Non-ISR AEs | Cohort 7b: Systemic/Non-ISR AEs |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Injection site bruisingGeneral disorders | 22/22 | 22/22 | 13/14 | 13/14 | 5/5 | 5/5 | 0/7 | 0/7 | 10/10 | 10/10 | 19/19 | 19/19 | 0/7 | 0/7 | 7/7 | 7/7 | — | — | — | — | — | — | — | — |
| Injection site haemorrhageGeneral disorders | 0/22 | 0/22 | 0/14 | 0/14 | 0/5 | 0/5 | 7/7 | 7/7 | 0/10 | 0/10 | 0/19 | 0/19 | 7/7 | 6/7 | 0/7 | 0/7 | — | — | — | — | — | — | — | — |
| Injection site painGeneral disorders | 7/22 | 8/22 | 0/14 | 0/14 | 1/5 | 1/5 | 0/7 | 0/7 | 9/10 | 9/10 | 2/19 | 2/19 | 2/7 | 0/7 | 1/7 | 3/7 | — | — | — | — | — | — | — | — |
| Injection site discolourationGeneral disorders | 10/22 | 10/22 | 0/14 | 0/14 | 3/5 | 3/5 | 2/7 | 2/7 | 1/10 | 1/10 | 1/19 | 1/19 | 2/7 | 2/7 | 0/7 | 1/7 | — | — | — | — | — | — | — | — |
| Injection site noduleGeneral disorders | 1/22 | 0/22 | 0/14 | 0/14 | 0/5 | 0/5 | 0/7 | 0/7 | 4/10 | 4/10 | 2/19 | 2/19 | 1/7 | 1/7 | 0/7 | 0/7 | — | — | — | — | — | — | — | — |
| Injection site papuleGeneral disorders | 0/22 | 0/22 | 0/14 | 0/14 | 2/5 | 2/5 | 0/7 | 0/7 | 0/10 | 0/10 | 0/19 | 0/19 | 0/7 | 0/7 | 0/7 | 0/7 | — | — | — | — | — | — | — | — |
| Injection site pruritusGeneral disorders | 2/22 | 2/22 | 0/14 | 0/14 | 0/5 | 0/5 | 0/7 | 0/7 | 3/10 | 3/10 | 1/19 | 1/19 | 0/7 | 0/7 | 0/7 | 0/7 | — | — | — | — | — | — | — | — |
| HypertensionVascular disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 1/22 | 0/14 | 1/5 | 0/7 | 0/10 | 0/19 | 0/7 | 0/7 |
| AcneSkin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0/22 | 0/14 | 1/5 | 0/7 | 0/10 | 0/19 | 0/7 | 0/7 |
| HaematuriaRenal and urinary disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 0/22 | 0/14 | 1/5 | 0/7 | 0/10 | 0/19 | 0/7 | 0/7 |
All participants who received at least 1 injection of CCH-aaes.
| Age, Continuous(years) | Cohort 1: CCH-aaes Dose Evaluation | Cohort 2: CCH-aaes Concentration Evaluation | Cohort 3: CCH-aaes Injection Depth Evaluation | Cohort 4: CCH-aaes Injection Method Evaluation | Cohort 5: CCH-aaes and Diluent Additive Evaluation | Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 43.50 ± 10.698 | 44.79 ± 9.125 | 44.40 ± 8.503 | 34.00 ± 8.699 | 46.50 ± 10.179 | 47.74 ± 7.225 | 37.57 ± 10.967 | 38.57 ± 10.549 | 43.40 ± 9.998 |
| Sex: Female, Male(Participants) | Cohort 1: CCH-aaes Dose Evaluation | Cohort 2: CCH-aaes Concentration Evaluation | Cohort 3: CCH-aaes Injection Depth Evaluation | Cohort 4: CCH-aaes Injection Method Evaluation | Cohort 5: CCH-aaes and Diluent Additive Evaluation | Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 22 | 14 | 5 | 7 | 10 | 19 | 7 | 7 | 91 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Cohort 1: CCH-aaes Dose Evaluation | Cohort 2: CCH-aaes Concentration Evaluation | Cohort 3: CCH-aaes Injection Depth Evaluation | Cohort 4: CCH-aaes Injection Method Evaluation | Cohort 5: CCH-aaes and Diluent Additive Evaluation | Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Black or African American | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| White | 18 | 14 | 5 | 7 | 9 | 18 | 6 | 7 | 84 |
| Other | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Multiple | 2 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
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Studies of the drug tested here: Microbial Collagenase