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EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02942160
Recruitment Status : Completed
First Posted : October 21, 2016
Results First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Edematous Fibrosclerotic Panniculopathy
Cellulite
Intervention Biological: Collagenase Clostridium Histolyticum
Enrollment 259
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EN3835 Treated Participants in EN3835-202
Hide Arm/Group Description

Observation Phase (259 Started & 222 Completed):

Observation of Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum or with Placebo in Study EN3835-201

EN3835 Treated Participants in EN3835-202:

Buttock & Thigh Treatment Regions Treated with EN3835 0.84mg Collagenase Clostridium Histolyticum

Period Title: Overall Study
Started 259 [1]
EN3835-202 Participants 222 [2]
EN3835 Treated Subjects in EN3835-202 200 [3]
Completed 156 [4]
Not Completed 103
[1]
Observation Phase prior to open-label treatment phase
[2]
Observation Phase Completed
[3]
EN3835 Treated Participants in EN3835-202 Started
[4]
EN3835 Treated Participants in EN3835-202 Completed
Arm/Group Title EN3835 Treatment Regions
Hide Arm/Group Description Buttock & Thigh Treatment Regions Treated with EN3835 0.84mg Collagenase Clostridium Histolyticum
Overall Number of Baseline Participants 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants
48.0  (11.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
Female
200
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
Hispanic or Latino
46
  23.0%
Not Hispanic or Latino
154
  77.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
25
  12.5%
White
173
  86.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 200 participants
29.3  (6.78)
1.Primary Outcome
Title Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EN3835 Treatment Regions
Hide Arm/Group Description:
Buttocks & Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
Observation Visit Day 180 Number Analyzed 19 participants
Yes
19
 100.0%
No
0
   0.0%
Observation Visit Day 360 Number Analyzed 16 participants
Yes
16
 100.0%
No
0
   0.0%
2.Secondary Outcome
Title Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EN3835 Treatment Regions
Hide Arm/Group Description:
Buttocks & Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
Overall Number of Participants Analyzed 53
Measure Type: Count of Participants
Unit of Measure: Participants
Observation Durability Visit Day 180 Number Analyzed 53 participants
Yes
50
  94.3%
No
3
   5.7%
Observation Durability Visit Day 360 Number Analyzed 45 participants
Yes
43
  95.6%
No
2
   4.4%
3.Secondary Outcome
Title Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EN3835 Treatment Regions
Hide Arm/Group Description:
Buttocks & Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
Long-term Durability Visit Day 540 Yes
7
 100.0%
No
0
   0.0%
Long-term Durability Visit Day 720 Yes
7
 100.0%
No
0
   0.0%
4.Secondary Outcome
Title Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EN3835 Treatment Regions
Hide Arm/Group Description:
Buttocks & Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
Long-term Durability Visit Day 540 Yes
22
  95.7%
No
1
   4.3%
Long-term Durability Visit Day 720 Yes
21
  91.3%
No
2
   8.7%
5.Secondary Outcome
Title CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Observation Population included all participants who rolled over from Study EN3835-201 (all 259 participants that rolled over in Observation Phase).
Arm/Group Title EN3835 0.84 mg Placebo
Hide Arm/Group Description:
Treatment in Study EN3835-201
Placebo in Study EN3835-201
Overall Number of Participants Analyzed 121 138
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change from Baseline on Day 71 (EN3835-201 Study) Number Analyzed 121 participants 138 participants
-0.8  (0.88) -0.3  (0.60)
Change from Baseline-Observation Visit Day 180 Number Analyzed 120 participants 137 participants
-0.6  (0.80) -0.2  (0.67)
Change from Baseline-Observation Visit Day 270 Number Analyzed 106 participants 89 participants
-0.6  (0.76) -0.1  (0.63)
Change from Baseline-Observation Visit Day 360 Number Analyzed 97 participants 20 participants
-0.9  (0.86) -0.5  (0.83)
6.Secondary Outcome
Title CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EN3835 Treatment Regions
Hide Arm/Group Description:
Buttocks & Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change from Baseline (BL) to Treatment Day 22 Number Analyzed 154 participants
-0.6  (0.68)
Change from Baseline (BL) to Treatment Day 43 Number Analyzed 160 participants
-0.8  (0.71)
Change from Baseline (BL) to Treatment Day 71 Number Analyzed 159 participants
-1.0  (0.79)
Change from BL to Treatment Observation Day 180 Number Analyzed 154 participants
-1.0  (0.80)
Change from BL to Treatment Observation Day 360 Number Analyzed 142 participants
-0.9  (0.77)
7.Secondary Outcome
Title PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness Population
Arm/Group Title EN3835 Treatment Regions
Hide Arm/Group Description:
Buttocks & Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change from Baseline (BL) to Treatment Day 22 Number Analyzed 154 participants
-0.5  (0.64)
Change from Baseline (BL) to Treatment Day 43 Number Analyzed 160 participants
-0.8  (0.75)
Change from Baseline (BL) to Treatment Day 71 Number Analyzed 159 participants
-1.1  (0.82)
Change from BL to Treatment Observation Day 180 Number Analyzed 155 participants
-1.0  (0.83)
Change from BL to Treatment Observation Day 360 Number Analyzed 143 participants
-1.0  (0.83)
8.Secondary Outcome
Title Change From Baseline on the Hexsel CSS Total Score During the Observation Phase
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Observation Population included all participants who rolled over from Study EN3835-201 (all 259 participants that rolled over in Observation Phase).
Arm/Group Title EN3835 0.84 mg Placebo
Hide Arm/Group Description:
Treatment in Study EN3835-201
Placebo in Study EN3835-201
Overall Number of Participants Analyzed 121 138
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Point (in EN3835-201 Study) Number Analyzed 121 participants 138 participants
10.7  (1.32) 10.4  (1.41)
Day 71 Reference Point (in EN3835 Study) Number Analyzed 121 participants 138 participants
9.0  (2.42) 9.7  (2.20)
Change from Baseline (Day 71) Number Analyzed 121 participants 138 participants
-1.8  (2.22) -0.8  (1.81)
Observation Visit Day 360 Number Analyzed 97 participants 19 participants
8.6  (2.40) 9.5  (1.35)
Change from Baseline (Day 360) Number Analyzed 97 participants 19 participants
-2.2  (2.34) -1.2  (1.47)
9.Secondary Outcome
Title Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EN3835 Treatment Regions
Hide Arm/Group Description:
Buttocks & Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (in EN3835-201 Study) Number Analyzed 53 participants
10.6  (1.43)
Long-term Durability Visit Day 540-Change from BL Number Analyzed 6 participants
-3.5  (1.76)
Long-term Durability Visit Day 720-Change from BL Number Analyzed 23 participants
-2.9  (1.74)
10.Secondary Outcome
Title Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EN3835 Treatment Regions
Hide Arm/Group Description:
Buttocks & Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: score on a scale
Second EN3835 Treatment: Baseline Number Analyzed 162 participants
10.5  (1.44)
Second EN3835 Treatment: Day 71 Number Analyzed 159 participants
8.3  (2.41)
Second EN3835 Treatment: Change from Baseline Number Analyzed 159 participants
-2.2  (2.32)
Second EN3835: Treatment Observation Day 360 Number Analyzed 143 participants
8.1  (2.51)
Second EN3835: Change from Baseline Number Analyzed 143 participants
-2.4  (2.37)
11.Secondary Outcome
Title Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Observation Population included all participants who rolled over from Study EN3835-201 (all 259 participants that rolled over in Observation Phase).
Arm/Group Title EN3835 0.84 mg Placebo
Hide Arm/Group Description:
Treatment in Study EN3835-201
Placebo in Study EN3835-201
Overall Number of Participants Analyzed 97 19
Measure Type: Count of Participants
Unit of Measure: Participants
Very Much Improved (3)
4
   4.1%
0
   0.0%
Much Improved (2)
23
  23.7%
0
   0.0%
Improved (1)
36
  37.1%
4
  21.1%
No Change (0)
32
  33.0%
14
  73.7%
Worse (-1)
2
   2.1%
1
   5.3%
Much Worse (-2)
0
   0.0%
0
   0.0%
Very Much Worse (-3)
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EN3835 Treatment Regions
Hide Arm/Group Description:
Buttocks & Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
Overall Number of Participants Analyzed 162
Measure Type: Count of Participants
Unit of Measure: Participants
Second EN3835 Treatment: Treatment Day 71 Number Analyzed 159 participants
Very Much Improved (3)
10
   6.3%
Much Improved (2)
38
  23.9%
Improved (1)
73
  45.9%
No Change (0)
35
  22.0%
Worse (-1)
3
   1.9%
Much Worse (-2)
0
   0.0%
Very Much Worse (-3)
0
   0.0%
Second EN3835 Tx: Treatment Observation Day 360 Number Analyzed 142 participants
Very Much Improved (3)
5
   3.5%
Much Improved (2)
33
  23.2%
Improved (1)
64
  45.1%
No Change (0)
31
  21.8%
Worse (-1)
7
   4.9%
Much Worse (-2)
2
   1.4%
Very Much Worse (-3)
0
   0.0%
13.Secondary Outcome
Title Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Observation Population included all participants who rolled over from Study EN3835-201
Arm/Group Title EN3835 0.84 mg Placebo
Hide Arm/Group Description:
Treatment in Study EN3835-201
Placebo in Study EN3835-201
Overall Number of Participants Analyzed 97 19
Measure Type: Count of Participants
Unit of Measure: Participants
Very Much Improved (3)
3
   3.1%
0
   0.0%
Much Improved (2)
18
  18.6%
0
   0.0%
Improved (1)
46
  47.4%
4
  21.1%
No Change (0)
23
  23.7%
14
  73.7%
Worse (-1)
5
   5.2%
1
   5.3%
Much Worse (-2)
0
   0.0%
0
   0.0%
Very Much Worse (-3)
2
   2.1%
0
   0.0%
14.Secondary Outcome
Title Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EN3835 Treatment Regions
Hide Arm/Group Description:
Buttocks & Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
Overall Number of Participants Analyzed 162
Measure Type: Count of Participants
Unit of Measure: Participants
Second EN3835 Treatment: Treatment Day 71 Number Analyzed 159 participants
Very Much Improved (3)
16
  10.1%
Much Improved (2)
33
  20.8%
Improved (1)
69
  43.4%
No Change (0)
32
  20.1%
Worse (-1)
7
   4.4%
Much Worse (-2)
1
   0.6%
Very Much Worse (-3)
1
   0.6%
Second EN3835 Tx: Treatment Observation Day 360 Number Analyzed 143 participants
Very Much Improved (3)
16
  11.2%
Much Improved (2)
14
   9.8%
Improved (1)
64
  44.8%
No Change (0)
39
  27.3%
Worse (-1)
7
   4.9%
Much Worse (-2)
3
   2.1%
Very Much Worse (-3)
0
   0.0%
15.Secondary Outcome
Title Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360
Hide Description 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
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Hide Analysis Population Description
Observation Population included all participants who rolled over from Study EN3835-201
Arm/Group Title EN3835 0.84 mg Placebo
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Treatment in Study EN3835-201
Placebo in Study EN3835-201
Overall Number of Participants Analyzed 97 19
Measure Type: Count of Participants
Unit of Measure: Participants
Very Satisfied with Treatment (2)
14
  14.4%
0
   0.0%
Satisfied with Treatment (1)
41
  42.3%
4
  21.1%
Neither Dissatisfied nor Satisfied with Tretmt (0)
23
  23.7%
11
  57.9%
Dissatisfied with Treatment (-1)
14
  14.4%
4
  21.1%
Very Dissatisfied with Treatment (-2)
5
   5.2%
0
   0.0%
16.Secondary Outcome
Title Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment
Hide Description 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
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Hide Analysis Population Description
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/Group Title EN3835 Treatment Regions
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Buttocks & Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
Overall Number of Participants Analyzed 162
Measure Type: Count of Participants
Unit of Measure: Participants
Second EN3835 Treatment: Treatment Day 71 Number Analyzed 159 participants
Very Satisfied wth Treatment (2)
34
  21.4%
Satisfied with Treatment (1)
67
  42.1%
Neither Dissatisfied nor Satisfied with Tx (0)
36
  22.6%
Dissatisfied with Treatment (-1)
13
   8.2%
Very Dissatisfied with Treatment (-2)
9
   5.7%
Second EN3835 Treatment: Treatment Obsv Day 360 Number Analyzed 143 participants
Very Satisfied wth Treatment (2)
25
  17.5%
Satisfied with Treatment (1)
50
  35.0%
Neither Dissatisfied nor Satisfied with Tx (0)
45
  31.5%
Dissatisfied with Treatment (-1)
16
  11.2%
Very Dissatisfied with Treatment (-2)
7
   4.9%
17.Other Pre-specified Outcome
Title Overall Serum Antibody at Observation Visit Day 360
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EN3835 0.84 mg Placebo
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Treatment in Study EN3835-201
Placebo in Study EN3835-201
Overall Number of Participants Analyzed 19 4
Measure Type: Count of Participants
Unit of Measure: Participants
anti-AUX-I: Observation Visit Day 360 Seropositive
17
  89.5%
2
  50.0%
Seronegative
2
  10.5%
2
  50.0%
anti-AUX-II: Observation Visit Day 360 Seropositive
16
  84.2%
2
  50.0%
Seronegative
3
  15.8%
2
  50.0%
18.Other Pre-specified Outcome
Title Overall Antibody Log Titer Levels at Observation Visit Day 360
Hide Description Descriptive statistics are based on log10 transformation of titer levels.
Time Frame Day 360
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Hide Analysis Population Description
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/Group Title EN3835 0.84 mg Placebo
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Treatment in Study EN3835-201
Placebo in Study EN3835-201
Overall Number of Participants Analyzed 17 2
Mean (Standard Deviation)
Unit of Measure: log 10 titer
anti-AUX-I: Observation Visit Day 360 positive Number Analyzed 17 participants 2 participants
3.085  (1.192) 2.576  (0.213)
anti-AUX-II: Observation Visit Day 360 positive Number Analyzed 16 participants 2 participants
3.175  (1.239) 1.547  (0.315)
19.Other Pre-specified Outcome
Title Neutralizing Antibodies at Observation Visit Day 360
Hide Description Participants with binding antibodies were tested for neutralizing antibodies.
Time Frame Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
Observation Population included all participants who rolled over from Study EN3835-201 (259 participants in Observation Phase).Included Seropositive participants at Day 360.
Arm/Group Title EN3835 Treatment Regions
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Buttocks & Thighs Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
Neutralizing AUX-I Antibody Number Analyzed 18 participants
Negative
5
  27.8%
Positive
13
  72.2%
Neutralizing AUX-II Antibody Number Analyzed 23 participants
Negative
14
  60.9%
Positive
9
  39.1%
20.Other Pre-specified Outcome
Title Overall Antibody Log Titer Levels by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
Hide Description Descriptive statistics are based on Seropositive participants. Descriptive statistics are based on log10 transformation of titer levels.
Time Frame Day 1 to Day 360
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Hide Analysis Population Description
Safety Population included participants with seropositive antibody results
Arm/Group Title EN3835 Treatment Regions
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Buttocks & Thighs Treatment Regions Treated with EN3835 0.84mg Collagenase Clostridium Histolyticum
Overall Number of Participants Analyzed 163
Mean (Standard Deviation)
Unit of Measure: Log 10 titer
anti-AUX-I: Treatment Day 1 positive Number Analyzed 152 participants
4.038  (0.697)
anti-AUX-I: Treatment Day 71 positive Number Analyzed 151 participants
6.268  (0.786)
anti-AUX-I: Treatment Observation Day 360 positive Number Analyzed 139 participants
4.964  (0.584)
anti-AUX-II: Treatment Day 1 positive Number Analyzed 152 participants
3.853  (0.854)
anti-AUX-II: Treatment Day 71 positive Number Analyzed 151 participants
5.832  (0.736)
anti-AUX-II: Treatment Observation Day 360 positiv Number Analyzed 139 participants
4.714  (0.635)
21.Other Pre-specified Outcome
Title Neutralizing Antibodies in Treatment Phase for Participants With a Second EN3835 Treatment
Hide Description Tx Obs = Treatment Observation
Time Frame Day 71 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included participants with observed antibody levels at Day 71 in Q1 and Q4
Arm/Group Title EN3835 Treatment Regions
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Buttocks & Thighs Treatment Regions Treated with EN3835 0.84mg Collagenase Clostridium Histolyticum
Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment Day 71: Neutralizing AUX-I Antibody Number Analyzed 38 participants
Negative
2
   5.3%
Positive
36
  94.7%
Treatment Day 71: Neutralizing AUX-II Antibody Number Analyzed 35 participants
Negative
10
  28.6%
Positive
25
  71.4%
Tx Obs Day 360: Neutralizing AUX-I Antibody Number Analyzed 36 participants
Negative
21
  58.3%
Positive
15
  41.7%
Tx Obs Day 360: Neutralizing AUX-II Antibody Number Analyzed 35 participants
Negative
32
  91.4%
Positive
3
   8.6%
Time Frame 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)
Adverse Event Reporting Description

All (serious and nonserious) AEs, whether elicited or observed during study visits or spontaneously reported by the participant, including events that occurred from the time the participant signed the study-specific consent form until completion of or discharge from the study.

One death due to a motor vehicle accident reported in the Treatment Phase in a subject treated with EN3835 that was assessed as not related to EN3835.

 
Arm/Group Title Observation Phase EN3835 Treatment Phase
Hide Arm/Group Description Observation of Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum or with Placebo in Study EN3835-201 Buttock or Thigh Treated with EN3835: 0.84mg Collagenase Clostridium Histolyticum
All-Cause Mortality
Observation Phase EN3835 Treatment Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   0/259 (0.00%)   1/200 (0.50%) 
Hide Serious Adverse Events
Observation Phase EN3835 Treatment Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   1/259 (0.39%)   4/200 (2.00%) 
Infections and infestations     
Appendicitis  1  0/259 (0.00%)  1/200 (0.50%) 
Injury, poisoning and procedural complications     
Death from Motor Vehicle Accident  1  0/259 (0.00%)  1/200 (0.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast Cancer  1  0/259 (0.00%)  1/200 (0.50%) 
Pregnancy, puerperium and perinatal conditions     
Spontaneous Miscarriage  1  1/259 (0.39%)  0/200 (0.00%) 
Vascular disorders     
Hypertensive Urgency  1  0/259 (0.00%)  1/200 (0.50%) 
1
Term from vocabulary, MedDRA Version 19.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Observation Phase EN3835 Treatment Phase
Affected / at Risk (%) Affected / at Risk (%)
Total   0/259 (0.00%)   176/200 (88.00%) 
General disorders     
Injection site bruising  1  0/259 (0.00%)  170/200 (85.00%) 
Injection site pain  1  0/259 (0.00%)  113/200 (56.50%) 
Injection site nodule  1  0/259 (0.00%)  39/200 (19.50%) 
Injection site pruritus  1  0/259 (0.00%)  33/200 (16.50%) 
Injection site swelling  1  0/259 (0.00%)  19/200 (9.50%) 
Injection site discolouration  1  0/259 (0.00%)  18/200 (9.00%) 
Infections and infestations     
Upper respiratory tract infection  1 [1]  0/259 (0.00%)  11/200 (5.50%) 
1
Term from vocabulary, MedDRA Version 19.0
Indicates events were collected by systematic assessment
[1]
No AEs occurred at a frequency greater than or equal to 5% in Observation Phase
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Saji Vijayan, MBBS
Organization: Endo Pharmaceuticals
Phone: 800-462-3636
EMail: ClinicalTrials@Endo.com
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02942160    
Other Study ID Numbers: EN3835-202
First Submitted: October 20, 2016
First Posted: October 21, 2016
Results First Submitted: August 5, 2020
Results First Posted: November 24, 2020
Last Update Posted: November 24, 2020