Edematous Skin
Conditions
Keywords
Edematous Fibrosclerotic Panniculopathy, Cellulite, Collagenase Clostridium Histolyticum
Brief summary
The study will evaluate the safety and effectiveness of different injection techniques of Collagenase Clostridium Histolyticum (CCH) for the treatment of adult women with mild, moderate or severe Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).
Interventions
Endo Pharmaceuticals Inc. (Endo) is developing collagenase clostridium histolyticum (CCH) for the treatment of EFP. Because CCH is a proteinase that can hydrolyze the triple-helical region of collagen under physiological conditions, CCH has the potential to be effective in lysing sub-dermal collagen, such as those observed in the dermal septa, which are the underlying cause of the skin dimpling in women with Edematous Fibrosclerotic Panniculopathy (EFP). CCH targets the collagenase structural matrix (for example, dermal septa) at the site of injection and does not require systemic exposure to be effective.
Sponsors
Endo Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
No participant will be assigned to treatment until all eligibility criteria have been satisfied. To qualify for the study a participant must: 1. Be able to provide voluntary written informed consent prior to the initiation of any study specific procedures per the policy of the governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC). 2. Be female and at least 18 years of age at the time of consent. 3. Have evidence of cellulite in 2 bilateral treatment areas (defined as right and left buttocks or right and left posterolateral thighs) as assessed by the Investigator at the Screening visit, and fulfills the following requirements: 1. has a score of 2 (mild), 3 (moderate) or 4 (severe) as reported by the Investigator (CR-PCSS) in 2 treatment areas (two thighs or two buttocks) at the Screening Visit. 2. has at least 2 dimples from each treatment area that: * are isolated and separated by at least 5 centimeters (cm) from any other dimples. * score 2 or 3 on the Hexsel depression scale. * have dimple width: length ratio ≥ 0.5. 4. Be willing to apply sunscreen to the dosing areas before each exposure to the sun while participating in the study (that is, screening through end of study). 5. Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening. 6. Have a negative serum pregnancy test at the Screening Visit and negative urine pregnancy at Day 1 (before injection of study drug), be using an effective contraception method (for example, abstinence, intrauterine device, hormonal \[estrogen/progestin\] contraceptives, or double barrier control) for at least 1 menstrual cycle prior to study enrollment and through Day 71; or be menopausal defined as at least 12 months of amenorrhea in the absence of other biological or physiological causes (as determined by the Investigator), or be post-menopausal for at least 1 year, or be surgically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation). 7. Be willing and able to comply with all protocol required study visits and assessments.
Exclusion criteria
Participants who meet any of the following criteria will be excluded from the study: 1. Is pregnant or is intending to become pregnant during the study. 2. Is presently nursing/breastfeeding or providing breast milk. 3. Has any of the following systemic conditions: 1. Coagulation disorder. 2. Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there has been no recurrence in at least 5 years. 3. History of keloidal scarring or abnormal wound healing. 4. Concurrent diseases or conditions that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the participant's well-being. 5. Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values. 4. Has any of the following local conditions in the areas to be treated: 1. History of lower extremity thrombosis or post-thrombosis syndrome. 2. Vascular disorder (for example, varicose veins, telangiectasia). 3. Inflammation or active infection. 4. Severe skin laxity, flaccidity, and/or sagging. 5. Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer. 5. Has a tattoo located within 2 cm of the site of injection. 6. Requires anticoagulant or antiplatelet medication during the study or has received anticoagulant or antiplatelet medication (except for ≤ 150 mg aspirin daily) within 7 days before injection of study drug. 7. Has used any of the following for the treatment of EFP on the area to be treated within the timelines identified below or intends to use any of the following at any time during the course of the study: 1. Liposuction within the treatment areas during the 12-month period before injection of study drug. 2. Injections (for example, mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision and/or powered subcision) within the treatment areas during the 12-month period before injection of study drug. 3. Any investigational treatment for EFP/cellulite on treatment areas during the 12-month period before the injection of study drug. 4. Endermologie® or similar treatments within the treatment areas during the 6-month period before injection of study drug. 5. Massage therapy within the treatment areas during the 3-month period before injection of study drug. 6. Creams (for example, Celluvera™, TriLastin®) to prevent or mitigate EFP within the treatment areas during the 2-week period before injection of study drug. 8. Has received an investigational drug or treatment within 30 days before injection of study drug. 9. Has a known systemic allergy to collagenase or any other excipient of study drug. 10. Has a history of drug or alcohol abuse. 11. Intends to initiate an intensive sport or exercise program during the study. 12. Intends to initiate a weight reduction program during the study. 13. Intends to use tanning spray or tanning booths during the study. 14. Has previously received any collagenase treatments (for example, Santyl® ointment and/or XIAFLEX/XIAPEX®). 15. Was a participant in a previous cellulite clinical trial of EN3835: AUX-CC-830, AUX-CC-831, EN3835-102, EN3835-104, EN3835-201, EN3835-202, EN3835-205, EN3835-302, or EN3835-303. 16. Any other condition(s) that, in the Investigator's opinion, might indicate the participant is unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71 | Day 71 | Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 71 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh). |
| Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22 | Day 22 | Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 22 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh). |
| Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43 | Day 43 | Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 43 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh). |
| Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71 | Baseline, Day 71 | Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh) |
| Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22 | Baseline, Day 22 | Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh) |
| Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43 | Baseline, Day 43 | Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Dimple Volume by Treatment Region | Baseline, Day 22, Day 43, and Day 71 | For each treated buttock and thigh, 4 dimple parameters including the maximum length (largest straight line distance across the dimple), maximum width (largest straight line distance perpendicular to the maximum length measurement), surface are, and volume (between the base of the dimple and an interpolated surface) of the target dimple were assessed. A negative change from Day 1 indicated an improvement. Volume of Dimple from Day 1 pre-marking was analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the measurement for the average of left and right of treatment areas (that is, average of left buttock posterior and right buttock posterior; average of left thigh lateral, left thigh oblique, left thigh posterior, right thigh lateral, right thigh oblique, and right thigh posterior). |
Countries
United States
Participant flow
Pre-assignment details
Participants in each treatment region (buttocks or thighs) were assigned to 1 of 5 injection technique treatment arms. No participants were treated in both the buttocks and the thighs.
Participants by arm
| Arm | Count |
|---|---|
| Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL).
Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 6 |
| Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) In Treatment I, each injection consisted of a single skin injection of study drug administered as a shallow injection of three 0.1 mL aliquots (for a total injection volume of 0.3 mL).
Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 6 |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot.
Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 6 |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) In Treatment II, each injection consisted of a single skin injection of study drug administered as a single shallow injection of a 0.3 mL aliquot.
Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 7 |
| Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot.
Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 6 |
| Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) In Treatment III, each injection consisted of a single skin injection of study drug administered as a single deep injection of a 0.3 mL study drug aliquot.
Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 6 |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL).
Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 6 |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) In Treatment IV, each injection consisted of a single skin injection of study drug administered as five 0.3 mL aliquots (one deep and four shallow; total injection volume of 1.5 mL).
Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 7 |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL).
Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 7 |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) In Treatment V, each injection consisted of a single skin injection of study drug administered as a shallow injection of four 0.3 mL aliquots (for a total injection volume of 1.2 mL).
Each participant received 24 injections for a total dose of 1.68 mg of CCH (0.84 mg per treatment region) at each treatment visit. | 6 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Non-compliance | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) | Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | Total | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 10.95 | 45.6 years STANDARD_DEVIATION 9.55 | 50.2 years STANDARD_DEVIATION 9.85 | 48.7 years STANDARD_DEVIATION 15.95 | 52.2 years STANDARD_DEVIATION 13.04 | 47.3 years STANDARD_DEVIATION 11.17 | 51.5 years STANDARD_DEVIATION 11.93 | 44.7 years STANDARD_DEVIATION 8.19 | 49.0 years STANDARD_DEVIATION 12.75 | 48.4 years STANDARD_DEVIATION 10 | 39.8 years STANDARD_DEVIATION 10.26 |
| Body Mass Index (BMI) | 33.65 kg/m^2 STANDARD_DEVIATION 9.415 | 31.11 kg/m^2 STANDARD_DEVIATION 6.277 | 35.92 kg/m^2 STANDARD_DEVIATION 12.643 | 29.13 kg/m^2 STANDARD_DEVIATION 6.239 | 28.05 kg/m^2 STANDARD_DEVIATION 4.669 | 30.27 kg/m^2 STANDARD_DEVIATION 7.379 | 24.78 kg/m^2 STANDARD_DEVIATION 5.202 | 30.30 kg/m^2 STANDARD_DEVIATION 6.387 | 26.40 kg/m^2 STANDARD_DEVIATION 7.33 | 29.01 kg/m^2 STANDARD_DEVIATION 4.123 | 35.10 kg/m^2 STANDARD_DEVIATION 3.929 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 4 Participants | 3 Participants | 1 Participants | 32 Participants | 1 Participants | 4 Participants | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 1 Participants | 2 Participants | 3 Participants | 5 Participants | 31 Participants | 5 Participants | 2 Participants | 5 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 161.8 cm STANDARD_DEVIATION 2.14 | 164.4 cm STANDARD_DEVIATION 10.01 | 158.7 cm STANDARD_DEVIATION 3.67 | 163.0 cm STANDARD_DEVIATION 6.9 | 162.3 cm STANDARD_DEVIATION 3.88 | 163.2 cm STANDARD_DEVIATION 7.18 | 161.5 cm STANDARD_DEVIATION 8.96 | 162.2 cm STANDARD_DEVIATION 3.03 | 167.4 cm STANDARD_DEVIATION 10.55 | 164.4 cm STANDARD_DEVIATION 8.96 | 165.2 cm STANDARD_DEVIATION 6.65 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 14 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 6 Participants | 3 Participants | 6 Participants | 5 Participants | 48 Participants | 5 Participants | 6 Participants | 4 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 6 Participants | 6 Participants | 6 Participants | 63 Participants | 6 Participants | 6 Participants | 7 Participants | 7 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Skin Category (Fitzpatrick Scale) II (Fair) | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 12 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 0 Participants |
| Skin Category (Fitzpatrick Scale) III (Darker White) | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 11 Participants | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Skin Category (Fitzpatrick Scale) I (Pale White) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Skin Category (Fitzpatrick Scale) IV (Light Brown) | 3 Participants | 6 Participants | 2 Participants | 2 Participants | 1 Participants | 23 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants | 3 Participants |
| Skin Category (Fitzpatrick Scale) V (Brown) | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Skin Category (Fitzpatrick Scale) VI (Dark Brown or Black) | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 9 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants |
| Weight | 87.843 kg STANDARD_DEVIATION 23.6933 | 84.407 kg STANDARD_DEVIATION 20.2152 | 90.258 kg STANDARD_DEVIATION 30.2437 | 76.687 kg STANDARD_DEVIATION 13.387 | 74.117 kg STANDARD_DEVIATION 13.9682 | 80.012 kg STANDARD_DEVIATION 19.0943 | 65.038 kg STANDARD_DEVIATION 17.0083 | 75.660 kg STANDARD_DEVIATION 15.273 | 72.396 kg STANDARD_DEVIATION 15.6629 | 78.497 kg STANDARD_DEVIATION 12.0413 | 96.008 kg STANDARD_DEVIATION 14.9791 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 7 | 0 / 7 | 0 / 6 |
| other Total, other adverse events | 6 / 6 | 6 / 6 | 4 / 6 | 7 / 7 | 6 / 6 | 6 / 6 | 6 / 6 | 7 / 7 | 7 / 7 | 6 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 6 | 1 / 7 | 1 / 7 | 0 / 6 |
Outcome results
Primary
Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22
Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 22 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh).
Time frame: Day 22
Population: Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance improvement Likert scale rating at specified timepoint. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for the assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22 | 1.08 score on a scale |
| Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22 | 1.10 score on a scale |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22 | 0.75 score on a scale |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22 | 0.50 score on a scale |
| Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22 | 0.67 score on a scale |
| Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22 | 0.20 score on a scale |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22 | 0.83 score on a scale |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22 | 0.67 score on a scale |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22 | 1.00 score on a scale |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 22 | 1.10 score on a scale |
Primary
Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43
Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 43 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh).
Time frame: Day 43
Population: Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance improvement Likert scale rating at specified timepoint. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for the assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43 | 0.75 score on a scale |
| Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43 | 1.40 score on a scale |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43 | 1.10 score on a scale |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43 | 0.57 score on a scale |
| Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43 | 1.00 score on a scale |
| Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43 | -0.01 score on a scale |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43 | 1.17 score on a scale |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43 | 0.42 score on a scale |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43 | 1.21 score on a scale |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 43 | 0.70 score on a scale |
Primary
Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71
Aesthetic appearance improvement for each treatment area (buttocks or thighs) was assessed by a blinded central assessment, using a 5-point Likert scale with scores ranging from -1 to 3. Aesthetic improvement was scored as worse (-1), stayed the same (0), improved (1), much improved (2) and very much improved (3). The assessor evaluated the image at Day 71 in comparison with baseline and recorded the Likert score. Aesthetic appearance Likert scale scores were analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the response for the average of left and right of treatment area (that is, average of left buttock and right buttock or average of left thigh and right thigh).
Time frame: Day 71
Population: Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance improvement Likert scale rating at specified timepoint. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for the assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71 | 1.08 score on a scale |
| Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71 | 0.92 score on a scale |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71 | 1.08 score on a scale |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71 | 0.43 score on a scale |
| Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71 | 1.00 score on a scale |
| Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71 | 0.12 score on a scale |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71 | 0.50 score on a scale |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71 | 0.30 score on a scale |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71 | 1.29 score on a scale |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | Aesthetic Appearance Improvement Likert Scores by Treatment Region at Day 71 | 0.60 score on a scale |
Primary
Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22
Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh)
Time frame: Baseline, Day 22
Population: Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance Likert scale rating at specified timepoint. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for the assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22 | -0.83 score on a scale |
| Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22 | -0.30 score on a scale |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22 | -0.17 score on a scale |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22 | -0.43 score on a scale |
| Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22 | -0.17 score on a scale |
| Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22 | -0.20 score on a scale |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22 | -0.83 score on a scale |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22 | -0.67 score on a scale |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22 | -0.14 score on a scale |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 22 | -0.20 score on a scale |
Primary
Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43
Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh)
Time frame: Baseline, Day 43
Population: Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance Likert scale rating at specified timepoint. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for the assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43 | -0.92 score on a scale |
| Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43 | -0.40 score on a scale |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43 | -0.40 score on a scale |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43 | -0.43 score on a scale |
| Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43 | -0.50 score on a scale |
| Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43 | -0.40 score on a scale |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43 | -0.83 score on a scale |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43 | -0.67 score on a scale |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43 | -0.36 score on a scale |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 43 | -0.60 score on a scale |
Primary
Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71
Dimple depth depression for each treatment area was assessed by the Investigator using the Hexsel Cellulite Severity Scale (B). Dimple Depth Depression of Hexsel Cellulite Severity Scale (B) was assessed and graded as: no depression (0), superficial depressions (1), medium depth depressions (2) and deep depressions (3). A negative change in Hexsel CSS (B) from baseline indicated an improvement in depression depth. Change from Baseline in dimple depth depression of Hexsel Cellulite Severity Scale (B) was analyzed using linear mixed model with treatment arm, study visits, interaction of treatment arm and study visit as fixed effect. This model was fitted using the response for the average of left and right of treatment areas (that is, average of left buttock and right buttock; average of left thigh and right thigh)
Time frame: Baseline, Day 71
Population: Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance Likert scale rating at specified timepoint. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for the assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71 | -1.17 score on a scale |
| Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71 | -0.33 score on a scale |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71 | -0.08 score on a scale |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71 | -0.29 score on a scale |
| Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71 | -0.67 score on a scale |
| Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71 | -0.75 score on a scale |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71 | -0.83 score on a scale |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71 | -1.40 score on a scale |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71 | -0.36 score on a scale |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | Change From Baseline in Dimple Depth Depression (Hexsel CSS [B]) by Treatment Region at Day 71 | -0.80 score on a scale |
Secondary
Change From Baseline of Dimple Volume by Treatment Region
For each treated buttock and thigh, 4 dimple parameters including the maximum length (largest straight line distance across the dimple), maximum width (largest straight line distance perpendicular to the maximum length measurement), surface are, and volume (between the base of the dimple and an interpolated surface) of the target dimple were assessed. A negative change from Day 1 indicated an improvement. Volume of Dimple from Day 1 pre-marking was analyzed using linear mixed model with treatment arm, study visit, interaction of treatment arm and study visit as fixed effects. This model was fitted using the measurement for the average of left and right of treatment areas (that is, average of left buttock posterior and right buttock posterior; average of left thigh lateral, left thigh oblique, left thigh posterior, right thigh lateral, right thigh oblique, and right thigh posterior).
Time frame: Baseline, Day 22, Day 43, and Day 71
Population: Evaluable Population includes all participants in the Safety Population who had completed screening procedures and at least 1 baseline assessment of aesthetic appearance Likert scale rating at specified timepoint. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for the assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) | Change From Baseline of Dimple Volume by Treatment Region | Day 22 | -0.01 mm^3 |
| Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) | Change From Baseline of Dimple Volume by Treatment Region | Day 71 | -0.02 mm^3 |
| Treatment I: CCH Shallow Injection, 3 Aliquots (Buttocks) | Change From Baseline of Dimple Volume by Treatment Region | Day 43 | -0.02 mm^3 |
| Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | Change From Baseline of Dimple Volume by Treatment Region | Day 43 | -0.03 mm^3 |
| Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | Change From Baseline of Dimple Volume by Treatment Region | Day 71 | -0.02 mm^3 |
| Treatment I: CCH Shallow Injection, 3 Aliquots (Thighs) | Change From Baseline of Dimple Volume by Treatment Region | Day 22 | -0.02 mm^3 |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | Change From Baseline of Dimple Volume by Treatment Region | Day 71 | -0.04 mm^3 |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | Change From Baseline of Dimple Volume by Treatment Region | Day 22 | -0.001 mm^3 |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Buttocks) | Change From Baseline of Dimple Volume by Treatment Region | Day 43 | -0.02 mm^3 |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | Change From Baseline of Dimple Volume by Treatment Region | Day 71 | -0.02 mm^3 |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | Change From Baseline of Dimple Volume by Treatment Region | Day 22 | -0.04 mm^3 |
| Treatment II: CCH Shallow Injection, 1 Aliquot (Thighs) | Change From Baseline of Dimple Volume by Treatment Region | Day 43 | -0.04 mm^3 |
| Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | Change From Baseline of Dimple Volume by Treatment Region | Day 22 | -0.01 mm^3 |
| Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | Change From Baseline of Dimple Volume by Treatment Region | Day 43 | -0.01 mm^3 |
| Treatment III: CCH Deep Injection, 1 Aliquot (Buttocks) | Change From Baseline of Dimple Volume by Treatment Region | Day 71 | -0.01 mm^3 |
| Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | Change From Baseline of Dimple Volume by Treatment Region | Day 43 | 0.01 mm^3 |
| Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | Change From Baseline of Dimple Volume by Treatment Region | Day 22 | 0.00 mm^3 |
| Treatment III: CCH Deep Injection, 1 Aliquot (Thighs) | Change From Baseline of Dimple Volume by Treatment Region | Day 71 | 0.04 mm^3 |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | Change From Baseline of Dimple Volume by Treatment Region | Day 22 | -0.01 mm^3 |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | Change From Baseline of Dimple Volume by Treatment Region | Day 71 | -0.02 mm^3 |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Buttocks) | Change From Baseline of Dimple Volume by Treatment Region | Day 43 | -0.01 mm^3 |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | Change From Baseline of Dimple Volume by Treatment Region | Day 43 | -0.02 mm^3 |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | Change From Baseline of Dimple Volume by Treatment Region | Day 22 | -0.01 mm^3 |
| Treatment IV: CCH Deep and Shallow Injections, 5 Aliquots (Thighs) | Change From Baseline of Dimple Volume by Treatment Region | Day 71 | -0.02 mm^3 |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | Change From Baseline of Dimple Volume by Treatment Region | Day 43 | -0.04 mm^3 |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | Change From Baseline of Dimple Volume by Treatment Region | Day 22 | -0.04 mm^3 |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Buttocks) | Change From Baseline of Dimple Volume by Treatment Region | Day 71 | -0.05 mm^3 |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | Change From Baseline of Dimple Volume by Treatment Region | Day 22 | -0.04 mm^3 |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | Change From Baseline of Dimple Volume by Treatment Region | Day 71 | -0.05 mm^3 |
| Treatment V: CCH Shallow Injections, 4 Aliquots (Thighs) | Change From Baseline of Dimple Volume by Treatment Region | Day 43 | -0.06 mm^3 |