Cellulite, Edematous Fibrosclerotic Panniculopathy, Laxity; Skin
Conditions
Brief summary
This study is designed to investigate the safety and efficacy of collagenase clostridium histolyticum (CCH) for the treatment of mild to moderate edematous fibrosclerotic panniculopathy (cellulite) in participants with moderate to severe dermal laxity in the buttocks or thighs with comparison between two (2) different CCH injection techniques.
Interventions
DRUGcollagenase clostridium histolyticum
Delivered via uniform grid injection techniques.
Sponsors
Endo Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Have a body mass index of 18 to \<29.9 kilograms/square meters 2. Have either both buttocks or both posterolateral thighs with: 1. Score of 2 or 3 (mild or moderate cellulite) as reported by the investigator using the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2. Hexsel Cellulite Severity Scale (CSS) Subsection D Grade of Laxity, Flaccidity, or Sagging Skin score of 2 or 3 (moderate or severe) as determined by the investigator 3. Have a negative pregnancy test or be of non-childbearing potential 4. Be willing and able to cooperate with the requirements of the study 5. Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study (from the Screening Visit through the Day 180/Early Termination Visit).
Exclusion criteria
1. Has a history of hypersensitivity or allergy to collagenase or any other excipients of CCH. 2. During Screening has a CR-PCSS score of less than 2 or greater than 3 for the area to be treated (buttocks or thighs) and/or has a Hexsel CSS Subsection D Grade of Laxity, Flaccidity, or Sagging Skin score of less than 2 or greater than 3 (severe) for the areas to be treated (buttocks or thighs). 3. Has a coagulation disorder, which requires anticoagulant or antiplatelet medication during the study (except for ≤150 mg aspirin daily), or has taken anticoagulant or antiplatelet medication(s) within 14 days before injection of study treatment (except for ≤150 mg aspirin daily). 4. Is a prisoner, an individual with impaired decision making capacity, 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), or in the judgment of the investigator the participant is disadvantaged and vulnerable to coercion due to lack of education, or due to poor economic circumstances. 5. Has received any collagenase treatments at any time prior to treatment in this study and/or has received EN3835 or CCH in a previous investigational study for cellulite. 6. Is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study. 7. Has a history of scarring due to keloids or abnormal wound healing. 8. Has local (in areas to be treated) conditions (thrombosis, vascular disorder, active infection/inflammation, active cutaneous alteration, tattoo/mole) that restricts study participation 9. Has history of drug or alcohol abuse within the 5 years prior to the Screening Visit. 10. Has evidence of clinically significant abnormalities, as judged by the investigator, in any of the following: physical examination findings, electrocardiogram (ECG), clinical laboratory values, or vital signs. The sponsor's medical monitor will be required to review the results for confirmation of eligibility in the case of any of the following: abnormalities in electrocardiograms indicating corrected QT interval (QTc) prolongation of 470 milliseconds or greater; and clinical laboratory values of liver enzymes 11. Has used or intends to use any of the local application/therapies/injections/procedures that restricts study participation. 12. Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study. 13. For the subset of participants participating in the collection of ultrasound data, the following exclusions will apply: participants will be excluded who have: a history of a spinal laminectomy, a previous history or presence of vascular abnormalities (for example, deep vein thrombosis, thrombophlebitis), a healing fracture, an impaired sensation within, or near, the planned treatment area, or any implants within, or near, the planned treatment area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh | Day 180 | I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from Very Much Worse (-3), Much Worse (-2), Worse (-1), No Change (0), Improved (+1), Much Improved (+2), and Very Much Improved (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Days 28, 56, 84, 112, 140, and 180 | S-GAIS assessments were based on digital photographs, and were performed separately for each of 2 treatment areas. S-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the participant ranging from Very Much Worse (-3), Much Worse (-2), Worse (-1), No Change (0), Improved (+1), Much Improved (+2), and Very Much Improved (+3). One-level S-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the S-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented. |
| Change From Baseline in Body-Q Appraisal of Cellulite Total Score | Baseline, Day 180 | The Body-Q Appraisal of Cellulite is a subset of 11 questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. Total score is the sum of all 11 question scores. The minimum possible total score is 11 and the maximum possible total score is 44. Higher scores indicate the individual is less bothered by their cellulite. |
| Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Days 28, 56, 84, 112, and 140 | I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from Very Much Worse (-3), Much Worse (-2), Worse (-1), No Change (0), Improved (+1), Much Improved (+2), and Very Much Improved (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented. |
| Percentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies | Day 180 | Blood samples were collected to assess anti-clostridial class I collagenase (AUX-I) and anti-Clostridial class II collagenase (AUX-II) antibody levels. The percentage of participants who were positive for anti-AUX-I and anti-AUX-II antibodies are presented. |
| Percentage of Participants Positive for Neutralizing Antibodies to AUX-I and AUX-II | Day 180 | Blood samples were collected to assess neutralizing antibodies to AUX-I and AUX-II. The percentage of participants who were positive for neutralizing antibodies to AUX-I and AUX-II are presented. |
| Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Baseline, Days 28, 56, 84, 112,140, and 180 | Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite using a 4-point scale from a low of 0 to high of 3: 0 (absence of laxity, flaccidity, or sagging skin), 1 (slight draped appearance), 2 (moderate draped appearance), and 3 (severe draped appearance). The investigator or qualified designee used the Hexsel CSS Subsection D to assess the severity of dermal laxity in each buttock or each thigh independently. A decrease from baseline indicated a better outcome. |
Countries
United States
Participant flow
Pre-assignment details
Participants were randomized to receive treatment in either a uniform 0.1-milliliter (mL), 1-aliquot, grid injection technique or uniform 0.3-mL, 2-aliquot grid injection technique in a 1:1 ratio. Each participant had 2 treatment areas (each buttock or each thigh).
Participants by arm
| Arm | Count |
|---|---|
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttock or Thigh) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). | 16 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttock or Thigh) Dose per participant per treatment visit = up to 1.68 mg of CCH (0.84 mg in each treatment area). | 19 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttock or Thigh) | Total | Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttock or Thigh) |
|---|---|---|---|
| Age, Continuous | 42.51 years STANDARD_DEVIATION 6.225 | 41.70 years STANDARD_DEVIATION 7.472 | 40.73 years STANDARD_DEVIATION 8.844 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 31 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 31 Participants | 13 Participants |
| Sex: Female, Male Female | 19 Participants | 35 Participants | 16 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 19 |
| other Total, other adverse events | 16 / 16 | 19 / 19 |
| serious Total, serious adverse events | 0 / 16 | 0 / 19 |
Outcome results
Primary
Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh
I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from Very Much Worse (-3), Much Worse (-2), Worse (-1), No Change (0), Improved (+1), Much Improved (+2), and Very Much Improved (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.
Time frame: Day 180
Population: Modified Intent-to-Treat (mITT) Population: All enrolled participants who received at least 1 injection of CCH and who had at least 1 valid I-GAIS evaluation after the injection of CCH.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh | 85.7 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh | 87.5 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh | 75.0 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh | 80.0 percentage of participants |
Secondary
Change From Baseline in Body-Q Appraisal of Cellulite Total Score
The Body-Q Appraisal of Cellulite is a subset of 11 questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. Total score is the sum of all 11 question scores. The minimum possible total score is 11 and the maximum possible total score is 44. Higher scores indicate the individual is less bothered by their cellulite.
Time frame: Baseline, Day 180
Population: mITT Population: All enrolled participants who received at least 1 injection of CCH and who had an assessment as the specified timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Body-Q Appraisal of Cellulite Total Score | 13.4 units on a scale | Standard Deviation 11.12 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Body-Q Appraisal of Cellulite Total Score | 13.6 units on a scale | Standard Deviation 9.94 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Body-Q Appraisal of Cellulite Total Score | 10.0 units on a scale | Standard Deviation 5.81 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Body-Q Appraisal of Cellulite Total Score | 6.4 units on a scale | Standard Deviation 10.56 |
Secondary
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score
Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite using a 4-point scale from a low of 0 to high of 3: 0 (absence of laxity, flaccidity, or sagging skin), 1 (slight draped appearance), 2 (moderate draped appearance), and 3 (severe draped appearance). The investigator or qualified designee used the Hexsel CSS Subsection D to assess the severity of dermal laxity in each buttock or each thigh independently. A decrease from baseline indicated a better outcome.
Time frame: Baseline, Days 28, 56, 84, 112,140, and 180
Population: mITT Population: All enrolled participants who received at least 1 injection of CCH and who had an assessment as the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 28 Left Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 84 Right Treatment Area | -0.1 units on a scale | Standard Deviation 0.38 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 28 Right Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 140 Left Treatment Area | -0.4 units on a scale | Standard Deviation 0.53 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 112 Right Treatment Area | -0.1 units on a scale | Standard Deviation 0.38 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 180 Left Treatment Area | -0.3 units on a scale | Standard Deviation 0.49 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 84 Left Treatment Area | -0.1 units on a scale | Standard Deviation 0.38 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 56 Left Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 112 Left Treatment Area | -0.1 units on a scale | Standard Deviation 0.38 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 180 Right Treatment Area | -0.3 units on a scale | Standard Deviation 0.49 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 140 Right Treatment Area | -0.3 units on a scale | Standard Deviation 0.49 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 56 Right Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 56 Right Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 28 Left Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 28 Right Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 56 Left Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 84 Right Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 112 Right Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 140 Left Treatment Area | -0.1 units on a scale | Standard Deviation 0.35 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 140 Right Treatment Area | -0.1 units on a scale | Standard Deviation 0.35 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 180 Right Treatment Area | -0.1 units on a scale | Standard Deviation 0.64 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 84 Left Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 112 Left Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 180 Left Treatment Area | -0.1 units on a scale | Standard Deviation 0.64 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 140 Left Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 140 Right Treatment Area | -0.1 units on a scale | Standard Deviation 0.35 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 180 Left Treatment Area | -0.1 units on a scale | Standard Deviation 0.35 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 56 Left Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 28 Left Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 180 Right Treatment Area | -0.1 units on a scale | Standard Deviation 0.35 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 56 Right Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 28 Right Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 112 Left Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 84 Left Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 112 Right Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 84 Right Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 84 Left Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 56 Left Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 28 Left Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 56 Right Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 140 Right Treatment Area | -0.2 units on a scale | Standard Deviation 0.42 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 84 Right Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 180 Left Treatment Area | -0.6 units on a scale | Standard Deviation 0.52 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 112 Right Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 140 Left Treatment Area | -0.2 units on a scale | Standard Deviation 0.42 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 112 Left Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 180 Right Treatment Area | -0.5 units on a scale | Standard Deviation 0.53 |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score | Day 28 Right Treatment Area | 0.0 units on a scale | Standard Deviation 0 |
Secondary
Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh
I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from Very Much Worse (-3), Much Worse (-2), Worse (-1), No Change (0), Improved (+1), Much Improved (+2), and Very Much Improved (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.
Time frame: Days 28, 56, 84, 112, and 140
Population: mITT Population: All enrolled participants who received at least 1 injection of CCH and who had at least 1 valid I-GAIS evaluation after the injection of CCH.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 112 | 85.7 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 140 | 71.4 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 28 | 71.4 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 56 | 85.7 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 84 | 57.1 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 56 | 62.5 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 112 | 50.0 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 140 | 75.0 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 28 | 44.4 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 84 | 75.0 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 28 | 77.8 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 84 | 77.8 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 56 | 88.9 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 112 | 77.8 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 140 | 75.0 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 140 | 80.0 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 28 | 77.8 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 56 | 88.9 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 84 | 70.0 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh | Day 112 | 80.0 percentage of participants |
Secondary
Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh
S-GAIS assessments were based on digital photographs, and were performed separately for each of 2 treatment areas. S-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the participant ranging from Very Much Worse (-3), Much Worse (-2), Worse (-1), No Change (0), Improved (+1), Much Improved (+2), and Very Much Improved (+3). One-level S-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the S-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.
Time frame: Days 28, 56, 84, 112, 140, and 180
Population: mITT Population: All enrolled participants who received at least 1 injection of CCH and who had at least 1 valid S-GAIS evaluation after the injection of CCH.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 84 | 71.4 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 28 | 71.4 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 180 | 85.7 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 112 | 85.7 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 140 | 71.4 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 56 | 85.7 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 84 | 87.5 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 112 | 62.5 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 140 | 87.5 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 180 | 100.0 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 28 | 44.4 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 56 | 75.0 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 140 | 62.5 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 84 | 55.6 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 28 | 66.7 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 112 | 55.6 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 56 | 88.9 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 180 | 62.5 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 180 | 90.0 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 56 | 88.9 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 84 | 70.0 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 28 | 66.7 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 112 | 70.0 percentage of participants |
| Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Thighs) | Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh | Day 140 | 70.0 percentage of participants |
Secondary
Percentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies
Blood samples were collected to assess anti-clostridial class I collagenase (AUX-I) and anti-Clostridial class II collagenase (AUX-II) antibody levels. The percentage of participants who were positive for anti-AUX-I and anti-AUX-II antibodies are presented.
Time frame: Day 180
Population: mITT Population: All enrolled participants who received at least 1 injection of CCH and were assessed for anti-AUX-I and anti-AUX-II Antibodies at the specified timepoint. Immunogenicity analysis was conducted by overall participants and not treatment area/injection technique.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies | Anti-AUX-I Antibodies | 100 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies | Anti-AUX-II Antibodies | 100 percentage of participants |
Secondary
Percentage of Participants Positive for Neutralizing Antibodies to AUX-I and AUX-II
Blood samples were collected to assess neutralizing antibodies to AUX-I and AUX-II. The percentage of participants who were positive for neutralizing antibodies to AUX-I and AUX-II are presented.
Time frame: Day 180
Population: mITT Population: All enrolled participants who received at least 1 injection of CCH and who had an assessment as the specified timepoint. Immunogenicity analysis was conducted by overall participants and not treatment area/injection technique.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of Participants Positive for Neutralizing Antibodies to AUX-I and AUX-II | Neutralizing antibodies to AUX-I | 87.5 percentage of participants |
| Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks) | Percentage of Participants Positive for Neutralizing Antibodies to AUX-I and AUX-II | Neutralizing antibodies to AUX-II | 84.4 percentage of participants |