Cellulite, Edematous Fibrosclerotic Panniculopathy
Conditions
Brief summary
The study will evaluate the safety, effectiveness, and immunogenicity of EN3835 in the treatment of adult women with Edematous Fibrosclerotic Panniculopathy (Commonly known as Cellulite).
Interventions
BIOLOGICALCOLLAGENASE CLOSTRIDIUM HISTOLYTICUM
Injectable intervention
BIOLOGICALPlacebo Comparator
Sponsors
Endo Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be a female ≥18 years of age * At Screening visit, have at least 1 quadrant with: * a score of 3 or 4 (moderate or severe) as reported by the subject (PR- PCSS), and * a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and * a Hexsel CSS score no greater than 13 * At Day 1 visit, have an assigned quadrant with: * a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and * a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and * a Hexsel CSS score no greater than 13 * Be willing to apply sunscreen to the selected treatment quadrant before each exposure to the sun while participating in the study (ie, screening through end of study). * Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening * Have a negative urine pregnancy test at screening and be using an effective contraception method (eg, abstinence, intrauterine device \[IUD\], hormonal \[estrogen/progestin\] contraceptives, or double barrier method) for at least 1 menstrual cycle prior to study enrollment and for the duration of the study; or be menopausal defined as 12 months of amenorrhea in the absence of other biological or physiological causes, as determined by the investigator; or post-menopausal for at least 1 year; or be surgically sterile. * Be willing and able to cooperate with the requirements of the study * Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC). * Be able to read, complete and understand the Patient Reported Outcomes rating instruments in English
Exclusion criteria
* Has any of the following conditions: * Thyroid disease, unless controlled with medication for ≥6 months * Uncontrolled diabetes mellitus, as determined by the Investigator * Uncontrolled hypertension, as determined by the Investigator * Vascular disorder (eg, phlebitis or varicose veins) in area to be treated * Cushing's disease and/or use of systemic corticosteroids at a total daily dose greater than 5 mg prednisone (or equivalent) * History of lower extremity thrombosis or post-thrombosis syndrome * Documented autoimmune disorder such as lupus erythematosus, rheumatoid arthritis * Inflammation or active infection in area to be treated * Active cutaneous alteration in area to be treated including rash, eczema, psoriasis or skin cancer * History of keloidal scarring or abnormal wound healing * Coagulation disorder * Taking a medication for chronic anticoagulation (except for ≤150 mg aspirin daily)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Composite Responders of at Least 2-Level Improvement of Severity | Baseline, Day 71 | Percentage of composite responders defined as subjects with an improvement from baseline of at least 2-levels of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement on each scale for example would represent a change from a 4 (severe) to a 2 (mild). In order to be considered a responder a subject needs to have at least a 2-level improvement on both scales. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CR-PCSS Responder Analysis: 2-Levels of Severity | Baseline, Day 71 | Percentage of subjects with improvement from baseline of at least 2-levels of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild). |
| CR-PCSS Responder Analysis: 1-Level of Severity | Baseline, Day 71 | Percentage of subjects with improvement from baseline of at least 1-level of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate). |
| CR-PCSS Change From Baseline | Baseline, Day 71 | The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity. |
| PR-PCSS Responder Analysis: 2-Levels of Severity | Baseline, Day 71 | Percentage of subjects with improvement from baseline of at least 2-levels of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild). |
| PR-PCSS Responder Analysis: 1-Level of Severity | Baseline, Day 71 | Percentage of subjects with improvement from baseline of at least 1-level of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate). |
| Percentage of Composite Responders of at Least 1-Level Improvement of Severity | Baseline, Day 71 | Percentage of composite responders defined as subjects with improvement from baseline of at least 1-level of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement on each scale for example would represent a change from a 4 (severe) to a 3 (moderate). In order to be considered a responder a subject needs to have at least a 1-level improvement on both scales. |
| Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | Day 71 | On Day 71, the Investigator determined the degree of improvement from baseline in the treated area using the 7-point I-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3). |
| Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | Day 71 | At Day 71, subjects were asked to rate their opinion of the overall improvement of their treated area using the 7-point S-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3) |
| Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale | Day 71 | At Day 71, subjects were asked to rate their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings could be satisfied (+1), very satisfied (+2), neither satisfied nor dissatisfied (0), or dissatisfied (-1), very dissatisfied (-2). |
| Change in the Hexsel Cellulite Severity Scale (CSS) Total Score | Baseline, Day 71 | Investigator used the Hexsel CSS to assess the severity of cellulite. The total score could range from 0 (no cellulite) to 15 (extremely severe cellulite). Negative change in Hexsel CSS total score indicates an improvement in cellulite severity |
| PR-PCSS Change From Baseline | Baseline, Day 71 | The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EN3835 0.84 mg Three (3) treatment sessions of 0.84 mg of collagenase clostridium histolyticum separated by approximately 21 days.
Injectable intervention | 189 |
| Placebo Three (3) treatment sessions of placebo separated by approximately 21 days. Injectable intervention | 186 |
| Total | 375 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative | 1 | 0 |
| Overall Study | Adverse Event | 7 | 1 |
| Overall Study | Lost to Follow-up | 6 | 2 |
| Overall Study | Withdrawal by Subject | 7 | 1 |
Baseline characteristics
| Characteristic | EN3835 0.84 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 47.2 Participants STANDARD_DEVIATION 11.21 | 45.8 Participants STANDARD_DEVIATION 11.02 | 46.5 Participants STANDARD_DEVIATION 11.13 |
| Age, Customized 18-<25 years | 8 Participants | 9 Participants | 17 Participants |
| Age, Customized 25-34 years | 18 Participants | 21 Participants | 39 Participants |
| Age, Customized 35-44 years | 46 Participants | 47 Participants | 93 Participants |
| Age, Customized >=45 years | 117 Participants | 109 Participants | 226 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 37 Participants | 41 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 152 Participants | 145 Participants | 297 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 26 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 167 Participants | 157 Participants | 324 Participants |
| Region of Enrollment United States | 189 Participants | 186 Participants | 375 Participants |
| Sex: Female, Male Female | 189 Participants | 186 Participants | 375 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 | — / — | — / — |
| other Total, other adverse events | 148 / 189 | 30 / 186 |
| serious Total, serious adverse events | 1 / 189 | 0 / 186 |
Outcome results
Primary
Percentage of Composite Responders of at Least 2-Level Improvement of Severity
Percentage of composite responders defined as subjects with an improvement from baseline of at least 2-levels of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement on each scale for example would represent a change from a 4 (severe) to a 2 (mild). In order to be considered a responder a subject needs to have at least a 2-level improvement on both scales.
Time frame: Baseline, Day 71
Population: Analysis is based on ITT population; all randomized subjects who received at least 1 injection of study medication
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EN3835 0.84 mg | Percentage of Composite Responders of at Least 2-Level Improvement of Severity | 20 Participants |
| Placebo | Percentage of Composite Responders of at Least 2-Level Improvement of Severity | 3 Participants |
Secondary
Change in the Hexsel Cellulite Severity Scale (CSS) Total Score
Investigator used the Hexsel CSS to assess the severity of cellulite. The total score could range from 0 (no cellulite) to 15 (extremely severe cellulite). Negative change in Hexsel CSS total score indicates an improvement in cellulite severity
Time frame: Baseline, Day 71
Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EN3835 0.84 mg | Change in the Hexsel Cellulite Severity Scale (CSS) Total Score | -1.7 units on a scale | Standard Deviation 2.2 |
| Placebo | Change in the Hexsel Cellulite Severity Scale (CSS) Total Score | -0.9 units on a scale | Standard Deviation 2 |
Secondary
CR-PCSS Change From Baseline
The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity.
Time frame: Baseline, Day 71
Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EN3835 0.84 mg | CR-PCSS Change From Baseline | -0.7 units on a scale | Standard Deviation 0.83 |
| Placebo | CR-PCSS Change From Baseline | -0.3 units on a scale | Standard Deviation 0.62 |
Secondary
CR-PCSS Responder Analysis: 1-Level of Severity
Percentage of subjects with improvement from baseline of at least 1-level of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate).
Time frame: Baseline, Day 71
Population: Analysis is based on modified intent-to-treat (mITT) population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EN3835 0.84 mg | CR-PCSS Responder Analysis: 1-Level of Severity | 96 Participants |
| Placebo | CR-PCSS Responder Analysis: 1-Level of Severity | 53 Participants |
Secondary
CR-PCSS Responder Analysis: 2-Levels of Severity
Percentage of subjects with improvement from baseline of at least 2-levels of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild).
Time frame: Baseline, Day 71
Population: Analysis is based on modified intent-to-treat (mITT) population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EN3835 0.84 mg | CR-PCSS Responder Analysis: 2-Levels of Severity | 32 Participants |
| Placebo | CR-PCSS Responder Analysis: 2-Levels of Severity | 9 Participants |
Secondary
Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)
On Day 71, the Investigator determined the degree of improvement from baseline in the treated area using the 7-point I-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3).
Time frame: Day 71
Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EN3835 0.84 mg | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | Very Much Improved (3) | 6 Participants |
| EN3835 0.84 mg | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | Much improved (2) | 40 Participants |
| EN3835 0.84 mg | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | Improved (1) | 64 Participants |
| EN3835 0.84 mg | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | No Change( 0) | 57 Participants |
| EN3835 0.84 mg | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | Worse (-1) | 6 Participants |
| EN3835 0.84 mg | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | Much worse (-2) | 2 Participants |
| EN3835 0.84 mg | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | Very Much Worse (-3) | 0 Participants |
| EN3835 0.84 mg | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | Not done | 2 Participants |
| Placebo | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | Not done | 1 Participants |
| Placebo | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | Very Much Improved (3) | 2 Participants |
| Placebo | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | Worse (-1) | 4 Participants |
| Placebo | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | Much improved (2) | 15 Participants |
| Placebo | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | Very Much Worse (-3) | 0 Participants |
| Placebo | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | Improved (1) | 43 Participants |
| Placebo | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | Much worse (-2) | 0 Participants |
| Placebo | Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS) | No Change( 0) | 119 Participants |
Secondary
Percentage of Composite Responders of at Least 1-Level Improvement of Severity
Percentage of composite responders defined as subjects with improvement from baseline of at least 1-level of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement on each scale for example would represent a change from a 4 (severe) to a 3 (moderate). In order to be considered a responder a subject needs to have at least a 1-level improvement on both scales.
Time frame: Baseline, Day 71
Population: Analysis is based on ITT population; all randomized subjects who received at least 1 injection of study medication
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EN3835 0.84 mg | Percentage of Composite Responders of at Least 1-Level Improvement of Severity | 79 Participants |
| Placebo | Percentage of Composite Responders of at Least 1-Level Improvement of Severity | 33 Participants |
Secondary
PR-PCSS Change From Baseline
The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity.
Time frame: Baseline, Day 71
Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EN3835 0.84 mg | PR-PCSS Change From Baseline | -1.0 units on a scale | Standard Deviation 0.89 |
| Placebo | PR-PCSS Change From Baseline | -0.7 units on a scale | Standard Deviation 0.79 |
Secondary
PR-PCSS Responder Analysis: 1-Level of Severity
Percentage of subjects with improvement from baseline of at least 1-level of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate).
Time frame: Baseline, Day 71
Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EN3835 0.84 mg | PR-PCSS Responder Analysis: 1-Level of Severity | 128 Participants |
| Placebo | PR-PCSS Responder Analysis: 1-Level of Severity | 95 Participants |
Secondary
PR-PCSS Responder Analysis: 2-Levels of Severity
Percentage of subjects with improvement from baseline of at least 2-levels of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild).
Time frame: Baseline, Day 71
Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EN3835 0.84 mg | PR-PCSS Responder Analysis: 2-Levels of Severity | 51 Participants |
| Placebo | PR-PCSS Responder Analysis: 2-Levels of Severity | 24 Participants |
Secondary
Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)
At Day 71, subjects were asked to rate their opinion of the overall improvement of their treated area using the 7-point S-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3)
Time frame: Day 71
Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EN3835 0.84 mg | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | Very Much Improved (3) | 21 Participants |
| EN3835 0.84 mg | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | Much Improved (2) | 43 Participants |
| EN3835 0.84 mg | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | Improved (1) | 64 Participants |
| EN3835 0.84 mg | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | No change (0) | 38 Participants |
| EN3835 0.84 mg | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | Worse (-1) | 6 Participants |
| EN3835 0.84 mg | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | Much Worse (-2) | 3 Participants |
| EN3835 0.84 mg | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | Very Much Worse (-3) | 0 Participants |
| EN3835 0.84 mg | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | Not done | 2 Participants |
| Placebo | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | Not done | 2 Participants |
| Placebo | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | Very Much Improved (3) | 11 Participants |
| Placebo | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | Worse (-1) | 5 Participants |
| Placebo | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | Much Improved (2) | 17 Participants |
| Placebo | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | Very Much Worse (-3) | 0 Participants |
| Placebo | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | Improved (1) | 52 Participants |
| Placebo | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | Much Worse (-2) | 0 Participants |
| Placebo | Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS) | No change (0) | 97 Participants |
Secondary
Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale
At Day 71, subjects were asked to rate their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings could be satisfied (+1), very satisfied (+2), neither satisfied nor dissatisfied (0), or dissatisfied (-1), very dissatisfied (-2).
Time frame: Day 71
Population: Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EN3835 0.84 mg | Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale | Very Satisfied (2) | 41 Participants |
| EN3835 0.84 mg | Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale | Satisfied (1) | 69 Participants |
| EN3835 0.84 mg | Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale | Neither Satisfied nor Dissatisfied (0) | 45 Participants |
| EN3835 0.84 mg | Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale | Dissatisfied (-1) | 11 Participants |
| EN3835 0.84 mg | Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale | Very Dissatisfied (-2) | 9 Participants |
| EN3835 0.84 mg | Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale | Not done | 2 Participants |
| Placebo | Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale | Very Dissatisfied (-2) | 16 Participants |
| Placebo | Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale | Very Satisfied (2) | 25 Participants |
| Placebo | Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale | Dissatisfied (-1) | 18 Participants |
| Placebo | Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale | Satisfied (1) | 40 Participants |
| Placebo | Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale | Not done | 3 Participants |
| Placebo | Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale | Neither Satisfied nor Dissatisfied (0) | 82 Participants |