Cellulite, Edematous Fibrosclerotic Panniculopathy
Conditions
Brief summary
A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).
Interventions
BIOLOGICALCollagenase Clostridium Histolyticum
Sponsors
Endo Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for Observation Phase: * Voluntarily sign and date an informed consent agreement * Have participated in and completed the double-blind study EN3835-201 * Be willing to apply sunscreen to any treated quadrant before each exposure to sun Inclusion Criteria for Treatment Phase: * Voluntarily sign and date an informed consent agreement * Have participated in and completed the double-blind study EN3835-201 * Be willing to apply sunscreen to any treated quadrant before each exposure to sun * Have at least 1 quadrant with: a score of 3 or 4 (moderate or severe) as reported on the PCSS (Photonumeric Cellulite Severity Scale) by the subject or investigator, and a Hexsel CSS (Cellulite Severity Scale) score no greater than 13 * Be judged to be in good health * Have a negative urine pregnancy test at screening and be using an effective contraception method, be surgically sterile, or post-menopausal
Exclusion criteria
for Observation Phase: * None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase | Day 180 to Day 360 | Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from 0 (None) to 4 (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. Three participants were discontinued from the study after Day 180, percentages are based on the observed counts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment | Day 22 to Day 360 | Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from 0 (None) to 4 (Severe). A decrease in the PR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. |
| Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment | Day 71 - Day 360 | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from +3 (Very much improved) to -3 (Very much worse), an increase in the I-GAIS indicates an improvement in global aesthetics. Percentages are based on the number of all evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/dosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment course in Study EN3835-202. |
| Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 | Day 360 | Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from +3 (Very much improved) to -3 (Very much worse), an increase in S-GAIS indicates an improvement. Percentages are based on the number of all evaluable participants at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. |
| Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment | Day 71 - Day 360 | Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from +3 (Very much improved) to -3 (Very much worse). Percentages are based on the number of evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in EN3835-202 Study and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. Treatment phase is defined as the time period from the second EN3835 treatment date to the End of Study EN3835-202. |
| Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360 | Day 360 | Subject Satisfaction with Cellulite Treatment Scale is a 5-level scale designed for participants to assess their satisfaction with cellulite treatment. The scale ranges from +2 (I am very satisfied with the cellulite treatment on my buttocks or thighs) to -2 (I am very dissatisfied with the cellulite treatment on my buttocks or thighs). Percentages are based on the number of evaluable participants at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. (EFP = Edematous Fibrosclerotic Panniculopathy, aka Cellulite) |
| Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment | Day 71 - Day 360 | Subject Satisfaction with Cellulite Treatment Scale is a 5-level scale designed for participants to assess their satisfaction with cellulite treatment. The scale ranges from +2 (I am very satisfied with the cellulite treatment on my buttocks or thighs) to -2 (I am very dissatisfied with the cellulite treatment on my buttocks or thighs). Percentages are based on the number of evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in Study EN3835-202 and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. Treatment phase is defined as the time period from the second EN3835 treatment date to the End of Study EN3835-202. |
| Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase | Day 180 to Day 360 | Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from 0 (None) to 4 (Severe). A 1-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. |
| Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase | Day 540 to Day 720 | Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from 0 (None) to 4 (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from baseline for the treatment area treated with EN3835 in the double-blind Study (EN3835-201). |
| Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase | Day 540 to Day 720 | Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from 0 (None) to 4 (Severe). A 1-level composite responder is a participant who received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from baseline for the treatment area treated with EN3835 in the double-blind Study (EN3835-201). |
| CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase | Baseline (in EN3835-201 Study) to Observation Day 360 | Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from 0 (None) to 4 (Severe). A negative change from baseline indicates an improvement in cellulite severity. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. |
| CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment | Day 22 to Day 360 | Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from 0 (None) to 4 (Severe). A decrease in the CR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course Study EN3835-202 and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. |
| Change From Baseline on the Hexsel CSS Total Score During the Observation Phase | Baseline (in EN3835-201 Study) to Day 360 | The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of 0 to a high of 3, with higher scores signifying more severe cellulite. The Hexcel CSS total score is the sum of all 5 features and can range from 0 (no cellulite) to 15 (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score. |
| Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits | Day 540 to Day 720 | The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of 0 to a high of 3, with higher scores indicating more severe cellulite. The total score is a summation of all 5 features and can range from 0 (no cellulite) to 15 (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score. A negative change from baseline indicates an improvement in cellulite severity. |
| Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment | Baseline - Day 360 | The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of 0 to a high of 3. The total score is a summation of all 5 features and can range from 0 (no cellulite) to 15 (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score. Change from baseline is the visit total score minus baseline total score. A negative change from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. |
| Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase | Day 360 | Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from +3 (Very much improved) to -3 (Very much worse), an increase in the I-GAIS scores indicates an improvement in Global Aesthetic Score. Percentages are based on the number of all evaluable subjects at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing Antibodies at Observation Visit Day 360 | Day 360 | Participants with binding antibodies were tested for neutralizing antibodies. |
| Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment | Day 1 to Day 360 | Descriptive statistics are based on Seropositive participants. Descriptive statistics are based on log10 transformation of titer levels. |
| Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment | Day 71 to Day 360 | Tx Obs = Treatment Observation |
| Overall Antibody Log Titer Levels at Observation Visit Day 360 | Day 360 | Descriptive statistics are based on log10 transformation of titer levels. |
| Overall Serum Antibody at Observation Visit Day 360 | Day 360 | Percent of participants that are seropositive. Descriptive statistics are based on log10 transformation of titer levels. Percent is based on the number of subjects who had immunogenicity lab samples drawn at the visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EN3835 Treatment Regions Buttock & Thigh Treatment Regions Treated with EN3835 0.84mg Collagenase Clostridium Histolyticum | 200 |
| Total | 200 |
Baseline characteristics
| Characteristic | EN3835 Treatment Regions |
|---|---|
| Age, Continuous | 48.0 years STANDARD_DEVIATION 11.06 |
| Body Mass Index (BMI) | 29.3 kg/m^2 STANDARD_DEVIATION 6.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 154 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 173 Participants |
| Sex: Female, Male Female | 200 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 259 | 1 / 200 |
| other Total, other adverse events | 0 / 259 | 176 / 200 |
| serious Total, serious adverse events | 1 / 259 | 4 / 200 |
Outcome results
Primary
Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from 0 (None) to 4 (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. Three participants were discontinued from the study after Day 180, percentages are based on the observed counts.
Time frame: Day 180 to Day 360
Population: The Durability Population for Double-blind Treated Participants is defined as all participants in the Overall Durability Population for both who showed an improvement on Day 71 of at least 2-level on each scale (CR-PCSS and PR-PCSS) from the baseline for the treatment area treated with EN3835 in the double-blind study (EN3835-201).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EN3835 Treatment Regions | Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase | Observation Visit Day 180 | Yes | 19 Participants |
| EN3835 Treatment Regions | Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase | Observation Visit Day 180 | No | 0 Participants |
| EN3835 Treatment Regions | Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase | Observation Visit Day 360 | Yes | 16 Participants |
| EN3835 Treatment Regions | Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase | Observation Visit Day 360 | No | 0 Participants |
Secondary
Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits
The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of 0 to a high of 3, with higher scores indicating more severe cellulite. The total score is a summation of all 5 features and can range from 0 (no cellulite) to 15 (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score. A negative change from baseline indicates an improvement in cellulite severity.
Time frame: Day 540 to Day 720
Population: Durability Population in Double-blind Treated Participants is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from the baseline for the treatment area treated with EN3835 in the double-blind study (EN3835-201).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EN3835 Treatment Regions | Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits | Baseline (in EN3835-201 Study) | 10.6 score on a scale | Standard Deviation 1.43 |
| EN3835 Treatment Regions | Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits | Long-term Durability Visit Day 540-Change from BL | -3.5 score on a scale | Standard Deviation 1.76 |
| EN3835 Treatment Regions | Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits | Long-term Durability Visit Day 720-Change from BL | -2.9 score on a scale | Standard Deviation 1.74 |
Secondary
Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment
The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of 0 to a high of 3. The total score is a summation of all 5 features and can range from 0 (no cellulite) to 15 (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score. Change from baseline is the visit total score minus baseline total score. A negative change from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202.
Time frame: Baseline - Day 360
Population: Effectiveness Population included all safety participants who had a baseline and at least 1 post-baseline assessment on both the CR-PCSS and PR-PCSS on the treatment area selected for treatment in the current study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EN3835 Treatment Regions | Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Baseline | 10.5 score on a scale | Standard Deviation 1.44 |
| EN3835 Treatment Regions | Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Day 71 | 8.3 score on a scale | Standard Deviation 2.41 |
| EN3835 Treatment Regions | Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Change from Baseline | -2.2 score on a scale | Standard Deviation 2.32 |
| EN3835 Treatment Regions | Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835: Treatment Observation Day 360 | 8.1 score on a scale | Standard Deviation 2.51 |
| EN3835 Treatment Regions | Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835: Change from Baseline | -2.4 score on a scale | Standard Deviation 2.37 |
Secondary
Change From Baseline on the Hexsel CSS Total Score During the Observation Phase
The Hexsel Cellulite Severity Scale (CSS) is a photonumeric scale that evaluates 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature. Each of these features is evaluated on a 4-point scale from a low of 0 to a high of 3, with higher scores signifying more severe cellulite. The Hexcel CSS total score is the sum of all 5 features and can range from 0 (no cellulite) to 15 (extremely severe cellulite) and is designated in this study as the Hexsel CSS total score.
Time frame: Baseline (in EN3835-201 Study) to Day 360
Population: Observation Population included all participants who rolled over from Study EN3835-201 (all 259 participants that rolled over in Observation Phase).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EN3835 Treatment Regions | Change From Baseline on the Hexsel CSS Total Score During the Observation Phase | Day 71 Reference Point (in EN3835 Study) | 9.0 score on a scale | Standard Deviation 2.42 |
| EN3835 Treatment Regions | Change From Baseline on the Hexsel CSS Total Score During the Observation Phase | Observation Visit Day 360 | 8.6 score on a scale | Standard Deviation 2.4 |
| EN3835 Treatment Regions | Change From Baseline on the Hexsel CSS Total Score During the Observation Phase | Change from Baseline (Day 71) | -1.8 score on a scale | Standard Deviation 2.22 |
| EN3835 Treatment Regions | Change From Baseline on the Hexsel CSS Total Score During the Observation Phase | Change from Baseline (Day 360) | -2.2 score on a scale | Standard Deviation 2.34 |
| EN3835 Treatment Regions | Change From Baseline on the Hexsel CSS Total Score During the Observation Phase | Baseline Point (in EN3835-201 Study) | 10.7 score on a scale | Standard Deviation 1.32 |
| Placebo | Change From Baseline on the Hexsel CSS Total Score During the Observation Phase | Change from Baseline (Day 360) | -1.2 score on a scale | Standard Deviation 1.47 |
| Placebo | Change From Baseline on the Hexsel CSS Total Score During the Observation Phase | Baseline Point (in EN3835-201 Study) | 10.4 score on a scale | Standard Deviation 1.41 |
| Placebo | Change From Baseline on the Hexsel CSS Total Score During the Observation Phase | Day 71 Reference Point (in EN3835 Study) | 9.7 score on a scale | Standard Deviation 2.2 |
| Placebo | Change From Baseline on the Hexsel CSS Total Score During the Observation Phase | Change from Baseline (Day 71) | -0.8 score on a scale | Standard Deviation 1.81 |
| Placebo | Change From Baseline on the Hexsel CSS Total Score During the Observation Phase | Observation Visit Day 360 | 9.5 score on a scale | Standard Deviation 1.35 |
Secondary
CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from 0 (None) to 4 (Severe). A decrease in the CR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course Study EN3835-202 and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202.
Time frame: Day 22 to Day 360
Population: Effectiveness Population included all safety participants who had a baseline and at least 1 post-baseline assessment on both the CR-PCSS and PR-PCSS on the treatment area selected for treatment in Study EN3835-202.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EN3835 Treatment Regions | CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment | Change from Baseline (BL) to Treatment Day 22 | -0.6 score on a scale | Standard Deviation 0.68 |
| EN3835 Treatment Regions | CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment | Change from Baseline (BL) to Treatment Day 43 | -0.8 score on a scale | Standard Deviation 0.71 |
| EN3835 Treatment Regions | CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment | Change from Baseline (BL) to Treatment Day 71 | -1.0 score on a scale | Standard Deviation 0.79 |
| EN3835 Treatment Regions | CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment | Change from BL to Treatment Observation Day 180 | -1.0 score on a scale | Standard Deviation 0.8 |
| EN3835 Treatment Regions | CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment | Change from BL to Treatment Observation Day 360 | -0.9 score on a scale | Standard Deviation 0.77 |
Secondary
CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-level scale ranging from 0 (None) to 4 (Severe). A negative change from baseline indicates an improvement in cellulite severity. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.
Time frame: Baseline (in EN3835-201 Study) to Observation Day 360
Population: Observation Population included all participants who rolled over from Study EN3835-201 (all 259 participants that rolled over in Observation Phase).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EN3835 Treatment Regions | CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase | Change from Baseline-Observation Visit Day 270 | -0.6 score on a scale | Standard Deviation 0.76 |
| EN3835 Treatment Regions | CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase | Change from Baseline-Observation Visit Day 180 | -0.6 score on a scale | Standard Deviation 0.8 |
| EN3835 Treatment Regions | CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase | Change from Baseline-Observation Visit Day 360 | -0.9 score on a scale | Standard Deviation 0.86 |
| EN3835 Treatment Regions | CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase | Change from Baseline on Day 71 (EN3835-201 Study) | -0.8 score on a scale | Standard Deviation 0.88 |
| Placebo | CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase | Change from Baseline-Observation Visit Day 360 | -0.5 score on a scale | Standard Deviation 0.83 |
| Placebo | CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase | Change from Baseline-Observation Visit Day 180 | -0.2 score on a scale | Standard Deviation 0.67 |
| Placebo | CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase | Change from Baseline-Observation Visit Day 270 | -0.1 score on a scale | Standard Deviation 0.63 |
| Placebo | CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase | Change from Baseline on Day 71 (EN3835-201 Study) | -0.3 score on a scale | Standard Deviation 0.6 |
Secondary
Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from +3 (Very much improved) to -3 (Very much worse), an increase in the I-GAIS scores indicates an improvement in Global Aesthetic Score. Percentages are based on the number of all evaluable subjects at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.
Time frame: Day 360
Population: Observation Population included all participants who rolled over from Study EN3835-201 (all 259 participants that rolled over in Observation Phase).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase | Improved (1) | 36 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase | Worse (-1) | 2 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase | Much Improved (2) | 23 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase | Much Worse (-2) | 0 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase | No Change (0) | 32 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase | Very Much Worse (-3) | 0 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase | Very Much Improved (3) | 4 Participants |
| Placebo | Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase | Very Much Worse (-3) | 0 Participants |
| Placebo | Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase | Very Much Improved (3) | 0 Participants |
| Placebo | Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase | Much Improved (2) | 0 Participants |
| Placebo | Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase | Improved (1) | 4 Participants |
| Placebo | Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase | No Change (0) | 14 Participants |
| Placebo | Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase | Worse (-1) | 1 Participants |
| Placebo | Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase | Much Worse (-2) | 0 Participants |
Secondary
Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from +3 (Very much improved) to -3 (Very much worse), an increase in the I-GAIS indicates an improvement in global aesthetics. Percentages are based on the number of all evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/dosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment course in Study EN3835-202.
Time frame: Day 71 - Day 360
Population: Effectiveness Population included all safety participants who had a baseline and at least 1 post-baseline assessment on both the CR-PCSS and PR-PCSS on the treatment area selected for treatment in the current study.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Very Much Improved (3) | 10 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Much Improved (2) | 38 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Improved (1) | 73 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | No Change (0) | 35 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Worse (-1) | 3 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Much Worse (-2) | 0 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Very Much Worse (-3) | 0 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Tx: Treatment Observation Day 360 | Very Much Improved (3) | 5 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Tx: Treatment Observation Day 360 | Much Improved (2) | 33 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Tx: Treatment Observation Day 360 | Improved (1) | 64 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Tx: Treatment Observation Day 360 | No Change (0) | 31 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Tx: Treatment Observation Day 360 | Worse (-1) | 7 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Tx: Treatment Observation Day 360 | Much Worse (-2) | 2 Participants |
| EN3835 Treatment Regions | Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Tx: Treatment Observation Day 360 | Very Much Worse (-3) | 0 Participants |
Secondary
Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from 0 (None) to 4 (Severe). A 1-level composite responder is a participant who received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from baseline for the treatment area treated with EN3835 in the double-blind Study (EN3835-201).
Time frame: Day 540 to Day 720
Population: The Durability Population for Double-blind Treated Participants, defined as all participants who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from the baseline for the treatment area treated with EN3835 in the double-blind study (EN3835-201), and had an Observation at Day 540.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EN3835 Treatment Regions | Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase | Long-term Durability Visit Day 540 | Yes | 22 Participants |
| EN3835 Treatment Regions | Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase | Long-term Durability Visit Day 540 | No | 1 Participants |
| EN3835 Treatment Regions | Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase | Long-term Durability Visit Day 720 | Yes | 21 Participants |
| EN3835 Treatment Regions | Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase | Long-term Durability Visit Day 720 | No | 2 Participants |
Secondary
Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from 0 (None) to 4 (Severe). A 1-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 1-level from baseline on both the PR-PCSS and the CR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.
Time frame: Day 180 to Day 360
Population: The Durability Population for Double-blind Treated Participants is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from the baseline for the treatment area treated with EN3835 in the double-blind study (EN3835-201).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EN3835 Treatment Regions | Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase | Observation Durability Visit Day 180 | Yes | 50 Participants |
| EN3835 Treatment Regions | Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase | Observation Durability Visit Day 180 | No | 3 Participants |
| EN3835 Treatment Regions | Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase | Observation Durability Visit Day 360 | Yes | 43 Participants |
| EN3835 Treatment Regions | Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase | Observation Durability Visit Day 360 | No | 2 Participants |
Secondary
Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from 0 (None) to 4 (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Long-term Durability Phase is defined as all participants in the Overall Durability Population who showed an improvement on Day 71 of at least 1-level on each scale (CR-PCSS and PR-PCSS) from baseline for the treatment area treated with EN3835 in the double-blind Study (EN3835-201).
Time frame: Day 540 to Day 720
Population: The Durability Population for Double-blind Treated Participants, defined as all participants who showed an improvement on Day 71 of at least 2-level on each scale (CR-PCSS and PR-PCSS) from the baseline for the treatment area treated with EN3835 in the double-blind study (EN3835-201), and had an Observation at Day 540.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EN3835 Treatment Regions | Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase | Long-term Durability Visit Day 540 | Yes | 7 Participants |
| EN3835 Treatment Regions | Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase | Long-term Durability Visit Day 540 | No | 0 Participants |
| EN3835 Treatment Regions | Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase | Long-term Durability Visit Day 720 | Yes | 7 Participants |
| EN3835 Treatment Regions | Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase | Long-term Durability Visit Day 720 | No | 0 Participants |
Secondary
PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from 0 (None) to 4 (Severe). A decrease in the PR-PCSS score from baseline indicates an improvement in cellulite severity. Treatment phase is defined as the time period from the second EN3835 treatment date to the end of Study EN3835-202. One hundred sixty-two participants received a second treatment course in this study and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202.
Time frame: Day 22 to Day 360
Population: Effectiveness Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EN3835 Treatment Regions | PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment | Change from Baseline (BL) to Treatment Day 22 | -0.5 score on a scale | Standard Deviation 0.64 |
| EN3835 Treatment Regions | PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment | Change from Baseline (BL) to Treatment Day 43 | -0.8 score on a scale | Standard Deviation 0.75 |
| EN3835 Treatment Regions | PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment | Change from Baseline (BL) to Treatment Day 71 | -1.1 score on a scale | Standard Deviation 0.82 |
| EN3835 Treatment Regions | PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment | Change from BL to Treatment Observation Day 180 | -1.0 score on a scale | Standard Deviation 0.83 |
| EN3835 Treatment Regions | PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment | Change from BL to Treatment Observation Day 360 | -1.0 score on a scale | Standard Deviation 0.83 |
Secondary
Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360
Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from +3 (Very much improved) to -3 (Very much worse), an increase in S-GAIS indicates an improvement. Percentages are based on the number of all evaluable participants at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202.
Time frame: Day 360
Population: Observation Population included all participants who rolled over from Study EN3835-201
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 | Improved (1) | 46 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 | Worse (-1) | 5 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 | Much Improved (2) | 18 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 | Much Worse (-2) | 0 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 | No Change (0) | 23 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 | Very Much Worse (-3) | 2 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 | Very Much Improved (3) | 3 Participants |
| Placebo | Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 | Very Much Worse (-3) | 0 Participants |
| Placebo | Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 | Very Much Improved (3) | 0 Participants |
| Placebo | Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 | Much Improved (2) | 0 Participants |
| Placebo | Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 | Improved (1) | 4 Participants |
| Placebo | Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 | No Change (0) | 14 Participants |
| Placebo | Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 | Worse (-1) | 1 Participants |
| Placebo | Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 | Much Worse (-2) | 0 Participants |
Secondary
Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-point numeric scale that evaluates the improvement of the treated treatment area in global aesthetics. The scale ranges from +3 (Very much improved) to -3 (Very much worse). Percentages are based on the number of evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in EN3835-202 Study and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. Treatment phase is defined as the time period from the second EN3835 treatment date to the End of Study EN3835-202.
Time frame: Day 71 - Day 360
Population: Effectiveness Population included all safety participants who had a baseline and at least 1 post-baseline assessment on both the CR-PCSS and PR-PCSS on the treatment area selected for treatment in Study EN3835-202.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Very Much Improved (3) | 16 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Much Improved (2) | 33 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Improved (1) | 69 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | No Change (0) | 32 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Worse (-1) | 7 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Much Worse (-2) | 1 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Very Much Worse (-3) | 1 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Tx: Treatment Observation Day 360 | Very Much Improved (3) | 16 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Tx: Treatment Observation Day 360 | Much Improved (2) | 14 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Tx: Treatment Observation Day 360 | Improved (1) | 64 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Tx: Treatment Observation Day 360 | No Change (0) | 39 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Tx: Treatment Observation Day 360 | Worse (-1) | 7 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Tx: Treatment Observation Day 360 | Much Worse (-2) | 3 Participants |
| EN3835 Treatment Regions | Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment | Second EN3835 Tx: Treatment Observation Day 360 | Very Much Worse (-3) | 0 Participants |
Secondary
Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360
Subject Satisfaction with Cellulite Treatment Scale is a 5-level scale designed for participants to assess their satisfaction with cellulite treatment. The scale ranges from +2 (I am very satisfied with the cellulite treatment on my buttocks or thighs) to -2 (I am very dissatisfied with the cellulite treatment on my buttocks or thighs). Percentages are based on the number of evaluable participants at each visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. (EFP = Edematous Fibrosclerotic Panniculopathy, aka Cellulite)
Time frame: Day 360
Population: Observation Population included all participants who rolled over from Study EN3835-201
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EN3835 Treatment Regions | Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360 | Satisfied with Treatment (1) | 41 Participants |
| EN3835 Treatment Regions | Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360 | Dissatisfied with Treatment (-1) | 14 Participants |
| EN3835 Treatment Regions | Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360 | Neither Dissatisfied nor Satisfied with Tretmt (0) | 23 Participants |
| EN3835 Treatment Regions | Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360 | Very Dissatisfied with Treatment (-2) | 5 Participants |
| EN3835 Treatment Regions | Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360 | Very Satisfied with Treatment (2) | 14 Participants |
| Placebo | Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360 | Very Dissatisfied with Treatment (-2) | 0 Participants |
| Placebo | Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360 | Very Satisfied with Treatment (2) | 0 Participants |
| Placebo | Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360 | Satisfied with Treatment (1) | 4 Participants |
| Placebo | Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360 | Neither Dissatisfied nor Satisfied with Tretmt (0) | 11 Participants |
| Placebo | Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360 | Dissatisfied with Treatment (-1) | 4 Participants |
Secondary
Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment
Subject Satisfaction with Cellulite Treatment Scale is a 5-level scale designed for participants to assess their satisfaction with cellulite treatment. The scale ranges from +2 (I am very satisfied with the cellulite treatment on my buttocks or thighs) to -2 (I am very dissatisfied with the cellulite treatment on my buttocks or thighs). Percentages are based on the number of evaluable participants at each visit. One hundred sixty-two participants received a second treatment course in Study EN3835-202 and were included in the Effectiveness Population. This retreated/redosed treatment group comprised 87 participants that received their second treatment course of EN3835 in Study EN3835-202 having received their first treatment course in Study EN3835-201 and 75 participants that received both their first and second treatment courses in Study EN3835-202. Treatment phase is defined as the time period from the second EN3835 treatment date to the End of Study EN3835-202.
Time frame: Day 71 - Day 360
Population: Effectiveness Population included all safety participants who had a baseline and at least 1 post-baseline assessment on both the CR-PCSS and PR-PCSS on the treatment area selected for treatment in Study EN3835-202.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EN3835 Treatment Regions | Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Very Satisfied wth Treatment (2) | 34 Participants |
| EN3835 Treatment Regions | Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Satisfied with Treatment (1) | 67 Participants |
| EN3835 Treatment Regions | Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Neither Dissatisfied nor Satisfied with Tx (0) | 36 Participants |
| EN3835 Treatment Regions | Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Dissatisfied with Treatment (-1) | 13 Participants |
| EN3835 Treatment Regions | Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Day 71 | Very Dissatisfied with Treatment (-2) | 9 Participants |
| EN3835 Treatment Regions | Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Obsv Day 360 | Very Satisfied wth Treatment (2) | 25 Participants |
| EN3835 Treatment Regions | Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Obsv Day 360 | Satisfied with Treatment (1) | 50 Participants |
| EN3835 Treatment Regions | Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Obsv Day 360 | Neither Dissatisfied nor Satisfied with Tx (0) | 45 Participants |
| EN3835 Treatment Regions | Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Obsv Day 360 | Dissatisfied with Treatment (-1) | 16 Participants |
| EN3835 Treatment Regions | Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment | Second EN3835 Treatment: Treatment Obsv Day 360 | Very Dissatisfied with Treatment (-2) | 7 Participants |
Other Pre-specified
Neutralizing Antibodies at Observation Visit Day 360
Participants with binding antibodies were tested for neutralizing antibodies.
Time frame: Day 360
Population: Observation Population included all participants who rolled over from Study EN3835-201 (259 participants in Observation Phase).Included Seropositive participants at Day 360.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EN3835 Treatment Regions | Neutralizing Antibodies at Observation Visit Day 360 | Neutralizing AUX-I Antibody | Negative | 5 Participants |
| EN3835 Treatment Regions | Neutralizing Antibodies at Observation Visit Day 360 | Neutralizing AUX-I Antibody | Positive | 13 Participants |
| EN3835 Treatment Regions | Neutralizing Antibodies at Observation Visit Day 360 | Neutralizing AUX-II Antibody | Negative | 14 Participants |
| EN3835 Treatment Regions | Neutralizing Antibodies at Observation Visit Day 360 | Neutralizing AUX-II Antibody | Positive | 9 Participants |
Other Pre-specified
Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment
Tx Obs = Treatment Observation
Time frame: Day 71 to Day 360
Population: Safety Population included participants with observed antibody levels at Day 71 in Q1 and Q4
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EN3835 Treatment Regions | Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment | Treatment Day 71: Neutralizing AUX-I Antibody | Negative | 2 Participants |
| EN3835 Treatment Regions | Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment | Treatment Day 71: Neutralizing AUX-I Antibody | Positive | 36 Participants |
| EN3835 Treatment Regions | Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment | Treatment Day 71: Neutralizing AUX-II Antibody | Negative | 10 Participants |
| EN3835 Treatment Regions | Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment | Treatment Day 71: Neutralizing AUX-II Antibody | Positive | 25 Participants |
| EN3835 Treatment Regions | Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment | Tx Obs Day 360: Neutralizing AUX-I Antibody | Negative | 21 Participants |
| EN3835 Treatment Regions | Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment | Tx Obs Day 360: Neutralizing AUX-I Antibody | Positive | 15 Participants |
| EN3835 Treatment Regions | Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment | Tx Obs Day 360: Neutralizing AUX-II Antibody | Negative | 32 Participants |
| EN3835 Treatment Regions | Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment | Tx Obs Day 360: Neutralizing AUX-II Antibody | Positive | 3 Participants |
Other Pre-specified
Overall Antibody Log Titer Levels at Observation Visit Day 360
Descriptive statistics are based on log10 transformation of titer levels.
Time frame: Day 360
Population: Observation Population included all participants who rolled over from Study EN3835-201 (all 259 participants that rolled over in Observation Phase). Included Seropositive participants at Day 360.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EN3835 Treatment Regions | Overall Antibody Log Titer Levels at Observation Visit Day 360 | anti-AUX-I: Observation Visit Day 360 positive | 3.085 log 10 titer | Standard Deviation 1.192 |
| EN3835 Treatment Regions | Overall Antibody Log Titer Levels at Observation Visit Day 360 | anti-AUX-II: Observation Visit Day 360 positive | 3.175 log 10 titer | Standard Deviation 1.239 |
| Placebo | Overall Antibody Log Titer Levels at Observation Visit Day 360 | anti-AUX-I: Observation Visit Day 360 positive | 2.576 log 10 titer | Standard Deviation 0.213 |
| Placebo | Overall Antibody Log Titer Levels at Observation Visit Day 360 | anti-AUX-II: Observation Visit Day 360 positive | 1.547 log 10 titer | Standard Deviation 0.315 |
Other Pre-specified
Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
Descriptive statistics are based on Seropositive participants. Descriptive statistics are based on log10 transformation of titer levels.
Time frame: Day 1 to Day 360
Population: Safety Population included participants with seropositive antibody results
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EN3835 Treatment Regions | Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment | anti-AUX-I: Treatment Day 1 positive | 4.038 Log 10 titer | Standard Deviation 0.697 |
| EN3835 Treatment Regions | Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment | anti-AUX-I: Treatment Day 71 positive | 6.268 Log 10 titer | Standard Deviation 0.786 |
| EN3835 Treatment Regions | Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment | anti-AUX-I: Treatment Observation Day 360 positive | 4.964 Log 10 titer | Standard Deviation 0.584 |
| EN3835 Treatment Regions | Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment | anti-AUX-II: Treatment Day 1 positive | 3.853 Log 10 titer | Standard Deviation 0.854 |
| EN3835 Treatment Regions | Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment | anti-AUX-II: Treatment Day 71 positive | 5.832 Log 10 titer | Standard Deviation 0.736 |
| EN3835 Treatment Regions | Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment | anti-AUX-II: Treatment Observation Day 360 positiv | 4.714 Log 10 titer | Standard Deviation 0.635 |
Other Pre-specified
Overall Serum Antibody at Observation Visit Day 360
Percent of participants that are seropositive. Descriptive statistics are based on log10 transformation of titer levels. Percent is based on the number of subjects who had immunogenicity lab samples drawn at the visit
Time frame: Day 360
Population: Observation Population included all participants who rolled over from Study EN3835-201 (259 participants in Observation Phase). Included all participants with collected samples at Day 360.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| EN3835 Treatment Regions | Overall Serum Antibody at Observation Visit Day 360 | anti-AUX-I: Observation Visit Day 360 | Seropositive | 17 Participants |
| EN3835 Treatment Regions | Overall Serum Antibody at Observation Visit Day 360 | anti-AUX-I: Observation Visit Day 360 | Seronegative | 2 Participants |
| EN3835 Treatment Regions | Overall Serum Antibody at Observation Visit Day 360 | anti-AUX-II: Observation Visit Day 360 | Seropositive | 16 Participants |
| EN3835 Treatment Regions | Overall Serum Antibody at Observation Visit Day 360 | anti-AUX-II: Observation Visit Day 360 | Seronegative | 3 Participants |
| Placebo | Overall Serum Antibody at Observation Visit Day 360 | anti-AUX-II: Observation Visit Day 360 | Seronegative | 2 Participants |
| Placebo | Overall Serum Antibody at Observation Visit Day 360 | anti-AUX-I: Observation Visit Day 360 | Seropositive | 2 Participants |
| Placebo | Overall Serum Antibody at Observation Visit Day 360 | anti-AUX-II: Observation Visit Day 360 | Seropositive | 2 Participants |
| Placebo | Overall Serum Antibody at Observation Visit Day 360 | anti-AUX-I: Observation Visit Day 360 | Seronegative | 2 Participants |