Cellulite, Edematous Fibrosclerotic Panniculopathy (EFP)
Conditions
Brief summary
This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP). Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or moderate EFP in the buttocks.
Interventions
DRUGEN3835
Collagenase Clostridium Histolyticum (CCH)
Sponsors
Endo Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Have both buttocks or both posterolateral thighs with: 1. A score of 2 or 3 (mild or moderate) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS). 2. A Hexsel Cellulite Severity Scale (CSS) Subsection D Grade of Laxity, Flaccidity, or Sagging Skin score of 0 (absence of laxity, flaccidity, or sagging skin), or 1 (slightly draped appearance) at the Screening Visit only. 2. Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study. 3. Be judged to be in good health. 4. Have a negative pregnancy test. 5. Be willing and able to cooperate with the requirements of the study.
Exclusion criteria
1. Is from a vulnerable population, as defined by the United States (US) Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full-time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC). 2. Has a history of sensitivity or allergy to collagenase or any other excipient of CCH. 3. Has systemic conditions (coagulation disorders, malignancy, keloidal scarring, abnormal wound healing) that restricts study participation. 4. Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation. 5. Has skin laxity or linear undulations on the treatment region (both buttocks or both thighs) that can be effaced by lifting skin. 6. Has a Hexsel CSS Subsection D Grade of laxity, flaccidity, or sagging skin of 2 (moderate draped appearance) or 3 (severe draped appearance). 7. Requires anticoagulant or antiplatelet medication during the study. 8. Has used or intends to use any of the local applications/therapies/injections/procedures that restricts study participation. 9. Has received any collagenase treatments at any time prior to treatment in this study and/or has received previous treatment with EN3835 or CCH for cellulite. 10. Has received treatment with an investigational product within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit. 11. Is pregnant and/or is providing breast milk in any manner, or plans to become pregnant and/or to provide breast milk during the course of the study. 12. Has any other condition(s) that, in the investigator's opinion, might indicate the subject to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh | 90 Days | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are Very Much Worse, Much Worse, Worse, No Change, Improved, Much Improved, and Very Much Improved. |
| The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock | 90 Days | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are Very Much Worse, Much Worse, Worse, No Change, Improved, Much Improved, and Very Much Improved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score | Day 90, Day 180 | The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center |
| The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh | Day 22, 43, and 180 | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are Very Much Worse, Much Worse, Worse, No Change, Improved, Much Improved, and Very Much Improved. |
| The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock | Day 22, 43, and 180 | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are Very Much Worse, Much Worse, Worse, No Change, Improved, Much Improved, and Very Much Improved. |
| Mean Change From Baseline in CR-PCSS for Each Buttock | Day 22, 43, 90 and 180 | Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-point photonumeric scale rating cellulite severity from 0 (none) to 4 (severe) from a clinician's perspective. |
| Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks) | Day 1, 90 and 180 | Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses |
| Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) | Day 1, 90 and 180 | All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb. |
| Presence of NAb Anti AUX-I and AUX-II (Buttocks) | Day 1, 90 and 180 | All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb. |
| Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh) | Day 1, 90, and 180 | Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses |
| Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score | Day 90, Day 180 | The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Posterolateral Thigh EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH) | 81 |
| Cohort 2: Buttocks EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)
EN3835: Collagenase Clostridium Histolyticum (CCH) | 72 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Cohort 2: Buttocks | Total | Cohort 1: Posterolateral Thigh |
|---|---|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 9.35 | 43.0 years STANDARD_DEVIATION 9.35 | 43.2 years STANDARD_DEVIATION 9.4 |
| BMI | 23.89 kg/m^2 STANDARD_DEVIATION 2.759 | 23.96 kg/m^2 STANDARD_DEVIATION 2.689 | 24.03 kg/m^2 STANDARD_DEVIATION 2.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 28 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 125 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 165.192 cm STANDARD_DEVIATION 6.6315 | 164.851 cm STANDARD_DEVIATION 6.4279 | 164.548 cm STANDARD_DEVIATION 6.2671 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 65 Participants | 139 Participants | 74 Participants |
| Sex: Female, Male Female | 72 Participants | 153 Participants | 81 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Skin Category (Fitzpatrick Scale) II (Fair) | 24 Participants | 57 Participants | 33 Participants |
| Skin Category (Fitzpatrick Scale) III (Darker White) | 28 Participants | 52 Participants | 24 Participants |
| Skin Category (Fitzpatrick Scale) I (Pale White) | 1 Participants | 3 Participants | 2 Participants |
| Skin Category (Fitzpatrick Scale) IV (Light Brown) | 14 Participants | 32 Participants | 18 Participants |
| Skin Category (Fitzpatrick Scale) V (Brown) | 4 Participants | 8 Participants | 4 Participants |
| Skin Category (Fitzpatrick Scale) VI (Dark Brown or Black) | 1 Participants | 1 Participants | 0 Participants |
| Weight | 65.042 kg STANDARD_DEVIATION 8.9403 | 65.063 kg STANDARD_DEVIATION 8.5961 | 65.082 kg STANDARD_DEVIATION 8.3341 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 72 |
| other Total, other adverse events | 75 / 81 | 69 / 72 |
| serious Total, serious adverse events | 0 / 81 | 0 / 72 |
Outcome results
Primary
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are Very Much Worse, Much Worse, Worse, No Change, Improved, Much Improved, and Very Much Improved.
Time frame: 90 Days
Population: Evaluable Population includes all participants who have at least 1 injection of study medication and have at least 1 I-GAIS evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Posterolateral Thigh | The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock | 58 Participants |
Primary
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are Very Much Worse, Much Worse, Worse, No Change, Improved, Much Improved, and Very Much Improved.
Time frame: 90 Days
Population: Evaluable Population includes all participants who have at least 1 injection of study medication and have at least 1 I-GAIS evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: Posterolateral Thigh | The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh | 58 Participants |
Secondary
Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score
The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center
Time frame: Day 90, Day 180
Population: Evaluable Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Posterolateral Thigh | Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score | Day 90 | 8.8 units on a scale | Standard Deviation 8.38 |
| Cohort 1: Posterolateral Thigh | Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score | Day 180 | 8.8 units on a scale | Standard Deviation 9.57 |
Secondary
Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score
The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center
Time frame: Day 90, Day 180
Population: Evaluable Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Posterolateral Thigh | Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score | Day 90 | 10.9 units on a scale | Standard Deviation 9.84 |
| Cohort 1: Posterolateral Thigh | Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score | Day 180 | 10.9 units on a scale | Standard Deviation 9.76 |
Secondary
Mean Change From Baseline in CR-PCSS for Each Buttock
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-point photonumeric scale rating cellulite severity from 0 (none) to 4 (severe) from a clinician's perspective.
Time frame: Day 22, 43, 90 and 180
Population: Evaluable Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation. Number of participants analyzed are evaluable population participants that had a change from baseline at the specified visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Posterolateral Thigh | Mean Change From Baseline in CR-PCSS for Each Buttock | Day 22 | -0.3 units on a scale | Standard Deviation 0.52 |
| Cohort 1: Posterolateral Thigh | Mean Change From Baseline in CR-PCSS for Each Buttock | Day 43 | -0.6 units on a scale | Standard Deviation 0.63 |
| Cohort 1: Posterolateral Thigh | Mean Change From Baseline in CR-PCSS for Each Buttock | Day 90 | -0.7 units on a scale | Standard Deviation 0.7 |
| Cohort 1: Posterolateral Thigh | Mean Change From Baseline in CR-PCSS for Each Buttock | Day 180 | -0.7 units on a scale | Standard Deviation 0.63 |
| Cohort 2: Buttocks (Right) | Mean Change From Baseline in CR-PCSS for Each Buttock | Day 180 | -0.6 units on a scale | Standard Deviation 0.63 |
| Cohort 2: Buttocks (Right) | Mean Change From Baseline in CR-PCSS for Each Buttock | Day 22 | -0.3 units on a scale | Standard Deviation 0.5 |
| Cohort 2: Buttocks (Right) | Mean Change From Baseline in CR-PCSS for Each Buttock | Day 90 | -0.7 units on a scale | Standard Deviation 0.53 |
| Cohort 2: Buttocks (Right) | Mean Change From Baseline in CR-PCSS for Each Buttock | Day 43 | -0.5 units on a scale | Standard Deviation 0.59 |
Secondary
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks)
Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
Time frame: Day 1, 90 and 180
Population: Safety Population includes all participants who received at least 1 injection of study medication
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Posterolateral Thigh | Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks) | Day 1 | 7 Participants |
| Cohort 1: Posterolateral Thigh | Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks) | Day 90 | 61 Participants |
| Cohort 1: Posterolateral Thigh | Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks) | Day 180 | 66 Participants |
| Cohort 2: Buttocks (Right) | Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks) | Day 1 | 5 Participants |
| Cohort 2: Buttocks (Right) | Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks) | Day 90 | 61 Participants |
| Cohort 2: Buttocks (Right) | Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks) | Day 180 | 65 Participants |
Secondary
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh)
Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
Time frame: Day 1, 90, and 180
Population: Safety Population includes all participants who received at least 1 injection of study medication
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Posterolateral Thigh | Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh) | Day 1 | 5 Participants |
| Cohort 1: Posterolateral Thigh | Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh) | Day 180 | 68 Participants |
| Cohort 1: Posterolateral Thigh | Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh) | Day 90 | 60 Participants |
| Cohort 2: Buttocks (Right) | Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh) | Day 1 | 5 Participants |
| Cohort 2: Buttocks (Right) | Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh) | Day 90 | 60 Participants |
| Cohort 2: Buttocks (Right) | Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh) | Day 180 | 68 Participants |
Secondary
Presence of NAb Anti AUX-I and AUX-II (Buttocks)
All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.
Time frame: Day 1, 90 and 180
Population: Subset of Safety Population samples were analyzed for NAbs. All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for the assessment. Percentages are based on number of participants tested for NAb at the visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: Posterolateral Thigh | Presence of NAb Anti AUX-I and AUX-II (Buttocks) | Day 180 | Negative | 2 Participants |
| Cohort 1: Posterolateral Thigh | Presence of NAb Anti AUX-I and AUX-II (Buttocks) | Day 1 | Negative | 0 Participants |
| Cohort 1: Posterolateral Thigh | Presence of NAb Anti AUX-I and AUX-II (Buttocks) | Day 180 | Positive | 15 Participants |
| Cohort 1: Posterolateral Thigh | Presence of NAb Anti AUX-I and AUX-II (Buttocks) | Day 90 | Positive | 15 Participants |
| Cohort 1: Posterolateral Thigh | Presence of NAb Anti AUX-I and AUX-II (Buttocks) | Day 1 | Positive | 2 Participants |
| Cohort 1: Posterolateral Thigh | Presence of NAb Anti AUX-I and AUX-II (Buttocks) | Day 90 | Negative | 2 Participants |
| Cohort 2: Buttocks (Right) | Presence of NAb Anti AUX-I and AUX-II (Buttocks) | Day 1 | Positive | 2 Participants |
| Cohort 2: Buttocks (Right) | Presence of NAb Anti AUX-I and AUX-II (Buttocks) | Day 180 | Positive | 9 Participants |
| Cohort 2: Buttocks (Right) | Presence of NAb Anti AUX-I and AUX-II (Buttocks) | Day 180 | Negative | 4 Participants |
| Cohort 2: Buttocks (Right) | Presence of NAb Anti AUX-I and AUX-II (Buttocks) | Day 90 | Negative | 4 Participants |
| Cohort 2: Buttocks (Right) | Presence of NAb Anti AUX-I and AUX-II (Buttocks) | Day 1 | Negative | 0 Participants |
| Cohort 2: Buttocks (Right) | Presence of NAb Anti AUX-I and AUX-II (Buttocks) | Day 90 | Positive | 9 Participants |
Secondary
Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.
Time frame: Day 1, 90 and 180
Population: Subset of Safety Population samples were analyzed for NAbs. All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for the assessment. Percentages are based on number of participants tested for NAb at the visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1: Posterolateral Thigh | Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) | Day 1 | Positive | 1 Participants |
| Cohort 1: Posterolateral Thigh | Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) | Day 1 | Negative | 1 Participants |
| Cohort 1: Posterolateral Thigh | Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) | Day 90 | Positive | 13 Participants |
| Cohort 1: Posterolateral Thigh | Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) | Day 90 | Negative | 0 Participants |
| Cohort 1: Posterolateral Thigh | Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) | Day 180 | Positive | 8 Participants |
| Cohort 1: Posterolateral Thigh | Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) | Day 180 | Negative | 3 Participants |
| Cohort 2: Buttocks (Right) | Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) | Day 180 | Positive | 12 Participants |
| Cohort 2: Buttocks (Right) | Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) | Day 1 | Positive | 0 Participants |
| Cohort 2: Buttocks (Right) | Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) | Day 90 | Negative | 1 Participants |
| Cohort 2: Buttocks (Right) | Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) | Day 1 | Negative | 1 Participants |
| Cohort 2: Buttocks (Right) | Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) | Day 180 | Negative | 3 Participants |
| Cohort 2: Buttocks (Right) | Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh) | Day 90 | Positive | 16 Participants |
Secondary
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are Very Much Worse, Much Worse, Worse, No Change, Improved, Much Improved, and Very Much Improved.
Time frame: Day 22, 43, and 180
Population: Evaluable Population includes all Participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Posterolateral Thigh | The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock | Day 22 | 50 Participants |
| Cohort 1: Posterolateral Thigh | The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock | Day 43 | 62 Participants |
| Cohort 1: Posterolateral Thigh | The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock | Day 180 | 59 Participants |
Secondary
The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are Very Much Worse, Much Worse, Worse, No Change, Improved, Much Improved, and Very Much Improved.
Time frame: Day 22, 43, and 180
Population: Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Posterolateral Thigh | The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh | Day 180 | 61 Participants |
| Cohort 1: Posterolateral Thigh | The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh | Day 22 | 64 Participants |
| Cohort 1: Posterolateral Thigh | The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh | Day 43 | 59 Participants |