Edematous Fibrosclerotic Panniculopathy, Cellulite
Conditions
Keywords
Collagenase Clostridium Histolyticum, collagenase clostridium histolyticum-aaes
Brief summary
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 \[CCH-aaes\]).
Detailed description
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.
Interventions
DRUGCCH-aaes
Administered by subcutaneous injection.
DRUGAntifibrinolytic Agent
Self-administered by participants enrolled in Cohort 7.
Sponsors
Endo Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Have a body mass index of 18 to \<32 kilograms (kg)/meter (m)\^2 and intends to maintain stable body weight during the study. * Have both buttocks with moderate or severe cellulite as reported by the investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). * Have a Hexsel Cellulite Severity Scale (CSS) Total Score of ≤12. * Has a Fitzpatrick Skin Type of I-IV * Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of participation in the study. * Be willing and able to comply with the requirements of the study. Key
Exclusion criteria
* Has systemic conditions (coagulation disorders, skin pigmentation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation. * Is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study. * Has any local (in the areas to be treated) conditions (thrombosis, post-thrombosis syndrome, vascular disorder, inflammation, active infection, active cutaneous alteration, tattoo or mole) that restricts study participation. * Requires antiplatelet medication, anticoagulants, or non-steroidal anti-inflammatory drugs during the study. * Any medications, supplements, or foods that have, or have been reported to have anticoagulant effects within 14 days of treatment. * Has received treatment with investigational treatment within 30 days before treatment. * Has used or intends to use any of the local applications, therapies, injections, or procedures for the treatment of cellulite on either buttock that would restrict study participation. * Intends to initiate an intensive sport or exercise program or intensive weight reduction program during the study. * Intends to engage in strenuous activity within 48 hours of study intervention administration. * Has recently tanned or intends to tan (outdoors or indoors) during the study. * Has a history of hypersensitivity or allergy to collagenase or any other excipient of CCH. * Has any condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study. * Has participated in a previous investigational study of CCH or received any collagenase treatments at any time prior to treatment in this study for the treatment of cellulite of the buttocks. In addition to the applicable aforementioned
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 1, 2, 3, and 4 after CCH-aaes injection of left buttock (test) and right buttock (control) | 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 With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | 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 | 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 With Injection Site Reactions | From Day 1 (after dose) through Day 180 | 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. |
Countries
United States
Participant flow
Pre-assignment details
Ninety-one participants were enrolled in this split-person study to compare different collagenase clostridium histolyticum-aaes (CCH-aaes) treatment regimens. Participants were administered study intervention in a split-buttock arrangement, with each participant's right buttock serving as the control to their assigned intervention administered to the left buttock (test).
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: CCH-aaes Dose Evaluation Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 milligrams \[mg\]) but maintaining the labeled concentration (0.23 mg/milliliters \[mL\]).
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) | 22 |
| Cohort 2: CCH-aaes Concentration Evaluation Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) but using an approximate 5-fold dilution (0.05 mg/mL) of the labeled concentration (0.23 mg/mL).
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL). | 14 |
| Cohort 3: CCH-aaes Injection Depth Evaluation Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but with an injection depth of one-quarter inch.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with labeled injection depth of one-half inch. | 5 |
| Cohort 4: CCH-aaes Injection Method Evaluation Participants left buttock (test) received CCH-aaes injection using an approximate 2.5-fold dilution of the labeled concentration (0.09 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 30 injections.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) but administering only a single aliquot at one-quarter-inch depth per injection administered at up to 12 injections. | 7 |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation Participants left buttock (test) received CCH-aaes injection using half the labeled dose (0.42 mg) with diluent additive.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL). | 10 |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation Participants left buttock (test) received CCH-aaes injection using one-quarter of the labeled dose (0.21 mg) at one-half the labeled concentration (0.12 mg/mL). Treatment sessions were administered 6 weeks apart.
Participants right buttock (control) received CCH-aaes injection using one-half the labeled dose (0.42 mg) but maintaining the labeled concentration (0.23 mg/mL). Treatment sessions were administered 6 weeks apart. | 19 |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL). | 7 |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent Participants left buttock (test) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL) with an antifibrinolytic agent treatment regimen.
Participants right buttock (control) received CCH-aaes injection using the labeled dose (0.84 mg) and concentration (0.23 mg/mL). | 7 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 | 0 | 0 | 1 | 2 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 43.50 years STANDARD_DEVIATION 10.698 | 44.79 years STANDARD_DEVIATION 9.125 | 44.40 years STANDARD_DEVIATION 8.503 | 34.00 years STANDARD_DEVIATION 8.699 | 46.50 years STANDARD_DEVIATION 10.179 | 47.74 years STANDARD_DEVIATION 7.225 | 37.57 years STANDARD_DEVIATION 10.967 | 38.57 years STANDARD_DEVIATION 10.549 | 43.40 years STANDARD_DEVIATION 9.998 |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Multiple | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 18 Participants | 14 Participants | 5 Participants | 7 Participants | 9 Participants | 18 Participants | 6 Participants | 7 Participants | 84 Participants |
| Sex: Female, Male Female | 22 Participants | 14 Participants | 5 Participants | 7 Participants | 10 Participants | 19 Participants | 7 Participants | 7 Participants | 91 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 22 | 0 / 14 | 0 / 5 | 0 / 7 | 0 / 10 | 0 / 19 | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 22 / 22 | 22 / 22 | 13 / 14 | 13 / 14 | 5 / 5 | 5 / 5 | 7 / 7 | 7 / 7 | 10 / 10 | 10 / 10 | 19 / 19 | 19 / 19 | 7 / 7 | 6 / 7 | 7 / 7 | 7 / 7 | 4 / 22 | 0 / 14 | 3 / 5 | 0 / 7 | 0 / 10 | 4 / 19 | 0 / 7 | 2 / 7 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 22 | 0 / 14 | 0 / 5 | 0 / 7 | 0 / 10 | 0 / 19 | 0 / 7 | 0 / 7 |
Outcome results
Primary
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)
Population: All participants who received at least 1 injection of CCH-aaes and who had at least 1 valid IABSS assessment after an injection of CCH-aaes at specified timepoint. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: CCH-aaes Dose Evaluation | 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 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | 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 | 25.0 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | 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 | 20.0 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | 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 | 33.3 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | 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 | 44.4 percentage of participants |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | 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 | 63.2 percentage of participants |
| Cohort 7a: 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 | 33.3 percentage of participants |
| 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 | 33.3 percentage of participants |
Secondary
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)
Population: All participants who received at least 1 injection of CCH-aaes and who had at least 1 valid IABSS assessment after an injection of CCH-aaes at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 1 | 81.8 percentage of participants |
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 2 | 90.5 percentage of participants |
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 3 | 40.9 percentage of participants |
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 4 | 13.6 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 4 | 18.2 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 2 | 25.0 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 1 | 15.4 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 3 | 38.5 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 1 | 0 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 4 | 0 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 2 | 20.0 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 3 | 40.0 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 1 | 42.9 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 2 | 33.3 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 3 | 28.6 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 4 | 14.3 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 4 | 10.0 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 3 | 10.0 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 2 | 44.4 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 1 | 40.0 percentage of participants |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 4 | 21.1 percentage of participants |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 3 | 31.6 percentage of participants |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 2 | 63.2 percentage of participants |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 1 | 44.4 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 4 | 16.7 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 1 | 16.7 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 3 | 40.0 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 2 | 33.3 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 2 | 33.3 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 3 | 42.9 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 4 | 71.4 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS | Follow-up 1 | 42.9 percentage of participants |
Secondary
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
Population: All participants who received at least 1 injection of CCH-aaes and who had at least 1 valid assessment at a treatment area after an injection of CCH-aaes.~For Cohort 7a, on Day 22, I-GAIS was only assessed for the investigational buttock (left buttock) and for Cohort 7b, on Day 22, I-GAIS was only assessed for the control buttock (right buttock).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Right Buttock (Control) | 36.8 percentage of participants |
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Left Buttock (Test) | 71.4 percentage of participants |
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 22 Left Buttock (Test) | 42.9 percentage of participants |
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Left Buttock (Test) | 38.1 percentage of participants |
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Right Buttock (Control) | 47.4 percentage of participants |
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Right Buttock (Control) | 76.2 percentage of participants |
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Left Buttock (Test) | 36.8 percentage of participants |
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 22 Right Buttock (Control) | 57.1 percentage of participants |
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Left Buttock (Test) | 36.8 percentage of participants |
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Right Buttock (Control) | 47.6 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Left Buttock (Test) | 90.9 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Right Buttock (Control) | 80.0 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Left Buttock (Test) | 100 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Left Buttock (Test) | 84.6 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 22 Right Buttock (Control) | 66.7 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 22 Left Buttock (Test) | 58.3 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Right Buttock (Control) | 76.9 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Right Buttock (Control) | 81.8 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Right Buttock (Control) | 81.8 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Left Buttock (Test) | 70.0 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Left Buttock (Test) | 100 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Right Buttock (Control) | 100 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Right Buttock (Control) | 100 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 22 Left Buttock (Test) | 100 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Right Buttock (Control) | 100 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 22 Right Buttock (Control) | 100 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Right Buttock (Control) | 100 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Left Buttock (Test) | 100 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Left Buttock (Test) | 100 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Left Buttock (Test) | 100 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 22 Left Buttock (Test) | 66.7 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Left Buttock (Test) | 50.0 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Left Buttock (Test) | 66.7 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Right Buttock (Control) | 83.3 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Right Buttock (Control) | 100 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Right Buttock (Control) | 66.7 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Right Buttock (Control) | 66.7 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Left Buttock (Test) | 83.3 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 22 Right Buttock (Control) | 66.7 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Left Buttock (Test) | 50.0 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Left Buttock (Test) | 11.1 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Right Buttock (Control) | 11.1 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 22 Right Buttock (Control) | 40.0 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Left Buttock (Test) | 66.7 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Right Buttock (Control) | 66.7 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 22 Left Buttock (Test) | 40.0 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Left Buttock (Test) | 44.4 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Right Buttock (Control) | 44.4 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Left Buttock (Test) | 22.2 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Right Buttock (Control) | 22.2 percentage of participants |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Right Buttock (Control) | 38.9 percentage of participants |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Left Buttock (Test) | 27.8 percentage of participants |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Left Buttock (Test) | 22.2 percentage of participants |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Right Buttock (Control) | 50.0 percentage of participants |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Left Buttock (Test) | 17.6 percentage of participants |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Right Buttock (Control) | 33.3 percentage of participants |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Left Buttock (Test) | 44.4 percentage of participants |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Right Buttock (Control) | 41.2 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Right Buttock (Control) | 40.0 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Right Buttock (Control) | 71.4 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Right Buttock (Control) | 66.7 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 22 Left Buttock (Test) | 85.7 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Left Buttock (Test) | 85.7 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Right Buttock (Control) | 66.7 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Left Buttock (Test) | 66.7 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Left Buttock (Test) | 100 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Left Buttock (Test) | 83.3 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 64 Right Buttock (Control) | 100 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 64 Left Buttock (Test) | 100 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Left Buttock (Test) | 100 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 22 Right Buttock (Control) | 100 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Left Buttock (Test) | 100 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 43 Right Buttock (Control) | 100 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 64 Left Buttock (Test) | 100 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 64 Right Buttock (Control) | 100 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Left Buttock (Test) | 100 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 90 (Follow-up) Right Buttock (Control) | 100 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 135 (Follow-up) Right Buttock (Control) | 83.3 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Left Buttock (Test) | 83.3 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection | Day 180 (End of Study) Right Buttock (Control) | 83.3 percentage of participants |
Secondary
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
Population: All participants who received at least 1 injection of CCH-aaes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With Injection Site Reactions | Right Buttock (Control) | 100 percentage of participants |
| Cohort 1: CCH-aaes Dose Evaluation | Percentage of Participants With Injection Site Reactions | Left Buttock (Test) | 100 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With Injection Site Reactions | Left Buttock (Test) | 92.9 percentage of participants |
| Cohort 2: CCH-aaes Concentration Evaluation | Percentage of Participants With Injection Site Reactions | Right Buttock (Control) | 92.9 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With Injection Site Reactions | Right Buttock (Control) | 100 percentage of participants |
| Cohort 3: CCH-aaes Injection Depth Evaluation | Percentage of Participants With Injection Site Reactions | Left Buttock (Test) | 100 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With Injection Site Reactions | Left Buttock (Test) | 100 percentage of participants |
| Cohort 4: CCH-aaes Injection Method Evaluation | Percentage of Participants With Injection Site Reactions | Right Buttock (Control) | 100 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With Injection Site Reactions | Right Buttock (Control) | 100 percentage of participants |
| Cohort 5: CCH-aaes and Diluent Additive Evaluation | Percentage of Participants With Injection Site Reactions | Left Buttock (Test) | 100 percentage of participants |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Percentage of Participants With Injection Site Reactions | Right Buttock (Control) | 100 percentage of participants |
| Cohort 6: CCH-aaes Dose, Concentration, and Treatment Schedule Evaluation | Percentage of Participants With Injection Site Reactions | Left Buttock (Test) | 100 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With Injection Site Reactions | Left Buttock (Test) | 100 percentage of participants |
| Cohort 7a: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With Injection Site Reactions | Right Buttock (Control) | 85.7 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With Injection Site Reactions | Right Buttock (Control) | 100 percentage of participants |
| Cohort 7b: CCH-aaes and Antifibrinolytic Agent | Percentage of Participants With Injection Site Reactions | Left Buttock (Test) | 100 percentage of participants |