A Phase 2 interventional study of Collagenase Clostridium Histolyticum in Edematous Fibrosclerotic Panniculopathy and Cellulite, sponsored by Endo Pharmaceuticals. Completed at 15 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-24.
Sponsored by Endo Pharmaceuticals · Phase 2, Interventional, and Treatment
A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).
Inclusion Criteria for Observation Phase:
Inclusion Criteria for Treatment Phase:
Exclusion Criteria for Observation Phase:
Exclusion Criteria for Treatment Phase:
EN3835 0.84mg (Collagenase Clostridium Histolyticum)
Biological: Collagenase Clostridium Histolyticum
Also known as: Xiaflex
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Overall Antibody Log Titer Levels at Observation Visit Day 360
Descriptive statistics are based on log10 transformation of titer levels.
Time frame: Day 360
Neutralizing Antibodies at Observation Visit Day 360
Participants with binding antibodies were tested for neutralizing antibodies.
Time frame: Day 360
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
Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment
Tx Obs = Treatment Observation
Time frame: Day 71 to Day 360
| Milestone | EN3835 Treated Participants in EN3835-202 |
|---|---|
| Started | 259 |
| En3835-202 participants | 222 |
| En3835 treated subjects in en3835-202 | 200 |
| Completed | 156 |
| Not completed | 103 |
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.
| Participants | EN3835 Treatment Regions |
|---|---|
| Observation Visit Day 180 — Yes | 19 |
| Observation Visit Day 180 — No | 0 |
| Observation Visit Day 360 — Yes | 16 |
| Observation Visit Day 360 — No | 0 |
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.
| Participants | EN3835 Treatment Regions |
|---|---|
| Observation Durability Visit Day 180 — Yes | 50 |
| Observation Durability Visit Day 180 — No | 3 |
| Observation Durability Visit Day 360 — Yes | 43 |
| Observation Durability Visit Day 360 — No | 2 |
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).
| Participants | EN3835 Treatment Regions |
|---|---|
| Long-term Durability Visit Day 540 — Yes | 7 |
| Long-term Durability Visit Day 540 — No | 0 |
| Long-term Durability Visit Day 720 — Yes | 7 |
| Long-term Durability Visit Day 720 — No | 0 |
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).
| Participants | EN3835 Treatment Regions |
|---|---|
| Long-term Durability Visit Day 540 — Yes | 22 |
| Long-term Durability Visit Day 540 — No | 1 |
| Long-term Durability Visit Day 720 — Yes | 21 |
| Long-term Durability Visit Day 720 — No | 2 |
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.
| score on a scale | EN3835 0.84 mg | Placebo |
|---|---|---|
| Change from Baseline on Day 71 (EN3835-201 Study) | -0.8 ± 0.88 | -0.3 ± 0.60 |
| Change from Baseline-Observation Visit Day 180 | -0.6 ± 0.80 | -0.2 ± 0.67 |
| Change from Baseline-Observation Visit Day 270 | -0.6 ± 0.76 | -0.1 ± 0.63 |
| Change from Baseline-Observation Visit Day 360 | -0.9 ± 0.86 | -0.5 ± 0.83 |
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.
| score on a scale | EN3835 Treatment Regions |
|---|---|
| Change from Baseline (BL) to Treatment Day 22 | -0.6 ± 0.68 |
| Change from Baseline (BL) to Treatment Day 43 | -0.8 ± 0.71 |
| Change from Baseline (BL) to Treatment Day 71 | -1.0 ± 0.79 |
| Change from BL to Treatment Observation Day 180 | -1.0 ± 0.80 |
| Change from BL to Treatment Observation Day 360 | -0.9 ± 0.77 |
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.
| score on a scale | EN3835 Treatment Regions |
|---|---|
| Change from Baseline (BL) to Treatment Day 22 | -0.5 ± 0.64 |
| Change from Baseline (BL) to Treatment Day 43 | -0.8 ± 0.75 |
| Change from Baseline (BL) to Treatment Day 71 | -1.1 ± 0.82 |
| Change from BL to Treatment Observation Day 180 | -1.0 ± 0.83 |
| Change from BL to Treatment Observation Day 360 | -1.0 ± 0.83 |
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.
| score on a scale | EN3835 0.84 mg | Placebo |
|---|---|---|
| Baseline Point (in EN3835-201 Study) | 10.7 ± 1.32 | 10.4 ± 1.41 |
| Day 71 Reference Point (in EN3835 Study) | 9.0 ± 2.42 | 9.7 ± 2.20 |
| Change from Baseline (Day 71) | -1.8 ± 2.22 | -0.8 ± 1.81 |
| Observation Visit Day 360 | 8.6 ± 2.40 | 9.5 ± 1.35 |
| Change from Baseline (Day 360) | -2.2 ± 2.34 | -1.2 ± 1.47 |
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.
| score on a scale | EN3835 Treatment Regions |
|---|---|
| Baseline (in EN3835-201 Study) | 10.6 ± 1.43 |
| Long-term Durability Visit Day 540-Change from BL | -3.5 ± 1.76 |
| Long-term Durability Visit Day 720-Change from BL | -2.9 ± 1.74 |
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.
| score on a scale | EN3835 Treatment Regions |
|---|---|
| Second EN3835 Treatment: Baseline | 10.5 ± 1.44 |
| Second EN3835 Treatment: Day 71 | 8.3 ± 2.41 |
| Second EN3835 Treatment: Change from Baseline | -2.2 ± 2.32 |
| Second EN3835: Treatment Observation Day 360 | 8.1 ± 2.51 |
| Second EN3835: Change from Baseline | -2.4 ± 2.37 |
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.
| Participants | EN3835 0.84 mg | Placebo |
|---|---|---|
| Very Much Improved (3) | 4 | 0 |
| Much Improved (2) | 23 | 0 |
| Improved (1) | 36 | 4 |
| No Change (0) | 32 | 14 |
| Worse (-1) | 2 | 1 |
| Much Worse (-2) | 0 | 0 |
| Very Much Worse (-3) | 0 | 0 |
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.
| Participants | EN3835 Treatment Regions |
|---|---|
| Second EN3835 Treatment: Treatment Day 71 — Very Much Improved (3) | 10 |
| Second EN3835 Treatment: Treatment Day 71 — Much Improved (2) | 38 |
| Second EN3835 Treatment: Treatment Day 71 — Improved (1) | 73 |
| Second EN3835 Treatment: Treatment Day 71 — No Change (0) | 35 |
| Second EN3835 Treatment: Treatment Day 71 — Worse (-1) | 3 |
| Second EN3835 Treatment: Treatment Day 71 — Much Worse (-2) | 0 |
| Second EN3835 Treatment: Treatment Day 71 — Very Much Worse (-3) | 0 |
| Second EN3835 Tx: Treatment Observation Day 360 — Very Much Improved (3) | 5 |
| Second EN3835 Tx: Treatment Observation Day 360 — Much Improved (2) | 33 |
| Second EN3835 Tx: Treatment Observation Day 360 — Improved (1) | 64 |
| Second EN3835 Tx: Treatment Observation Day 360 — No Change (0) | 31 |
| Second EN3835 Tx: Treatment Observation Day 360 — Worse (-1) | 7 |
| Second EN3835 Tx: Treatment Observation Day 360 — Much Worse (-2) | 2 |
| Second EN3835 Tx: Treatment Observation Day 360 — Very Much Worse (-3) | 0 |
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.
| Participants | EN3835 0.84 mg | Placebo |
|---|---|---|
| Very Much Improved (3) | 3 | 0 |
| Much Improved (2) | 18 | 0 |
| Improved (1) | 46 | 4 |
| No Change (0) | 23 | 14 |
| Worse (-1) | 5 | 1 |
| Much Worse (-2) | 0 | 0 |
| Very Much Worse (-3) | 2 | 0 |
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.
| Participants | EN3835 Treatment Regions |
|---|---|
| Second EN3835 Treatment: Treatment Day 71 — Very Much Improved (3) | 16 |
| Second EN3835 Treatment: Treatment Day 71 — Much Improved (2) | 33 |
| Second EN3835 Treatment: Treatment Day 71 — Improved (1) | 69 |
| Second EN3835 Treatment: Treatment Day 71 — No Change (0) | 32 |
| Second EN3835 Treatment: Treatment Day 71 — Worse (-1) | 7 |
| Second EN3835 Treatment: Treatment Day 71 — Much Worse (-2) | 1 |
| Second EN3835 Treatment: Treatment Day 71 — Very Much Worse (-3) | 1 |
| Second EN3835 Tx: Treatment Observation Day 360 — Very Much Improved (3) | 16 |
| Second EN3835 Tx: Treatment Observation Day 360 — Much Improved (2) | 14 |
| Second EN3835 Tx: Treatment Observation Day 360 — Improved (1) | 64 |
| Second EN3835 Tx: Treatment Observation Day 360 — No Change (0) | 39 |
| Second EN3835 Tx: Treatment Observation Day 360 — Worse (-1) | 7 |
| Second EN3835 Tx: Treatment Observation Day 360 — Much Worse (-2) | 3 |
| Second EN3835 Tx: Treatment Observation Day 360 — Very Much Worse (-3) | 0 |
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)
| Participants | EN3835 0.84 mg | Placebo |
|---|---|---|
| Very Satisfied with Treatment (2) | 14 | 0 |
| Satisfied with Treatment (1) | 41 | 4 |
| Neither Dissatisfied nor Satisfied with Tretmt (0) | 23 | 11 |
| Dissatisfied with Treatment (-1) | 14 | 4 |
| Very Dissatisfied with Treatment (-2) | 5 | 0 |
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.
| Participants | EN3835 Treatment Regions |
|---|---|
| Second EN3835 Treatment: Treatment Day 71 — Very Satisfied wth Treatment (2) | 34 |
| Second EN3835 Treatment: Treatment Day 71 — Satisfied with Treatment (1) | 67 |
| Second EN3835 Treatment: Treatment Day 71 — Neither Dissatisfied nor Satisfied with Tx (0) | 36 |
| Second EN3835 Treatment: Treatment Day 71 — Dissatisfied with Treatment (-1) | 13 |
| Second EN3835 Treatment: Treatment Day 71 — Very Dissatisfied with Treatment (-2) | 9 |
| Second EN3835 Treatment: Treatment Obsv Day 360 — Very Satisfied wth Treatment (2) | 25 |
| Second EN3835 Treatment: Treatment Obsv Day 360 — Satisfied with Treatment (1) | 50 |
| Second EN3835 Treatment: Treatment Obsv Day 360 — Neither Dissatisfied nor Satisfied with Tx (0) | 45 |
| Second EN3835 Treatment: Treatment Obsv Day 360 — Dissatisfied with Treatment (-1) | 16 |
| Second EN3835 Treatment: Treatment Obsv Day 360 — Very Dissatisfied with Treatment (-2) | 7 |
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
| Participants | EN3835 0.84 mg | Placebo |
|---|---|---|
| anti-AUX-I: Observation Visit Day 360 — Seropositive | 17 | 2 |
| anti-AUX-I: Observation Visit Day 360 — Seronegative | 2 | 2 |
| anti-AUX-II: Observation Visit Day 360 — Seropositive | 16 | 2 |
| anti-AUX-II: Observation Visit Day 360 — Seronegative | 3 | 2 |
Descriptive statistics are based on log10 transformation of titer levels.
| log 10 titer | EN3835 0.84 mg | Placebo |
|---|---|---|
| anti-AUX-I: Observation Visit Day 360 positive | 3.085 ± 1.192 | 2.576 ± 0.213 |
| anti-AUX-II: Observation Visit Day 360 positive | 3.175 ± 1.239 | 1.547 ± 0.315 |
Participants with binding antibodies were tested for neutralizing antibodies.
| Participants | EN3835 Treatment Regions |
|---|---|
| Neutralizing AUX-I Antibody — Negative | 5 |
| Neutralizing AUX-I Antibody — Positive | 13 |
| Neutralizing AUX-II Antibody — Negative | 14 |
| Neutralizing AUX-II Antibody — Positive | 9 |
Descriptive statistics are based on Seropositive participants. Descriptive statistics are based on log10 transformation of titer levels.
| Log 10 titer | EN3835 Treatment Regions |
|---|---|
| anti-AUX-I: Treatment Day 1 positive | 4.038 ± 0.697 |
| anti-AUX-I: Treatment Day 71 positive | 6.268 ± 0.786 |
| anti-AUX-I: Treatment Observation Day 360 positive | 4.964 ± 0.584 |
| anti-AUX-II: Treatment Day 1 positive | 3.853 ± 0.854 |
| anti-AUX-II: Treatment Day 71 positive | 5.832 ± 0.736 |
| anti-AUX-II: Treatment Observation Day 360 positiv | 4.714 ± 0.635 |
Tx Obs = Treatment Observation
| Participants | EN3835 Treatment Regions |
|---|---|
| Treatment Day 71: Neutralizing AUX-I Antibody — Negative | 2 |
| Treatment Day 71: Neutralizing AUX-I Antibody — Positive | 36 |
| Treatment Day 71: Neutralizing AUX-II Antibody — Negative | 10 |
| Treatment Day 71: Neutralizing AUX-II Antibody — Positive | 25 |
| Tx Obs Day 360: Neutralizing AUX-I Antibody — Negative | 21 |
| Tx Obs Day 360: Neutralizing AUX-I Antibody — Positive | 15 |
| Tx Obs Day 360: Neutralizing AUX-II Antibody — Negative | 32 |
| Tx Obs Day 360: Neutralizing AUX-II Antibody — Positive | 3 |
Collected over All (serious or nonserious) AEs, from Day 1 up to Day 720 (720 days after first exposure to study drug in predecessor study EN3835-201). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Observation Phase | 0/259 (0%) | 1/259 (0.4%) | 0/259 (0%) |
| EN3835 Treatment Phase | 1/200 (0.5%) | 4/200 (2%) | 176/200 (88%) |
| Event | Observation Phase | EN3835 Treatment Phase |
|---|---|---|
| AppendicitisInfections and infestations | 0/259 | 1/200 |
| Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/259 | 1/200 |
| Hypertensive UrgencyVascular disorders | 0/259 | 1/200 |
| Death from Motor Vehicle AccidentInjury, poisoning and procedural complications | 0/259 | 1/200 |
| Spontaneous MiscarriagePregnancy, puerperium and perinatal conditions | 1/259 | 0/200 |
| Event | Observation Phase | EN3835 Treatment Phase |
|---|---|---|
| Injection site bruisingGeneral disorders | 0/259 | 170/200 |
| Injection site painGeneral disorders | 0/259 | 113/200 |
| Injection site noduleGeneral disorders | 0/259 | 39/200 |
| Injection site pruritusGeneral disorders | 0/259 | 33/200 |
| Injection site swellingGeneral disorders | 0/259 | 19/200 |
| Injection site discolourationGeneral disorders | 0/259 | 18/200 |
| Upper respiratory tract infectionInfections and infestations | 0/259 | 11/200 |
| Age, Continuous(years) | EN3835 Treatment Regions |
|---|---|
| Mean | 48.0 ± 11.06 |
| Sex: Female, Male(Participants) | EN3835 Treatment Regions |
|---|---|
| Female | 200 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | EN3835 Treatment Regions |
|---|---|
| Hispanic or Latino | 46 |
| Not Hispanic or Latino | 154 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | EN3835 Treatment Regions |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 25 |
| White | 173 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Body Mass Index (BMI)(kg/m^2) | EN3835 Treatment Regions |
|---|---|
| Mean | 29.3 ± 6.78 |
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