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Safety and Effectiveness of EN3835 in the Treatment of EFP in Women

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ClinicalTrials.gov Identifier: NCT03329989
Recruitment Status : Completed
First Posted : November 6, 2017
Results First Posted : November 23, 2020
Last Update Posted : December 29, 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 158
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Collagenase Clostridium Histolyticum (CCH)
Hide Arm/Group Description 12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
Period Title: Overall Study
Started 158
Completed 135
Not Completed 23
Reason Not Completed
Withdrawal by Subject             9
Lost to Follow-up             8
Adverse Event             5
Protocol Violation             1
Arm/Group Title Collagenase Clostridium Histolyticum (CCH)
Hide Arm/Group Description 12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
Overall Number of Baseline Participants 158
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 158 participants
44.8  (10.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants
Female
158
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants
Hispanic or Latino
44
  27.8%
Not Hispanic or Latino
114
  72.2%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
17
  10.8%
White
135
  85.4%
More than one race
4
   2.5%
Unknown or Not Reported
0
   0.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 158 participants
26.74  (5.259)
Skin Category (Fitzpatrick Scale)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants
I (Pale White)
3
   1.9%
II (Fair)
34
  21.5%
III (Darker White)
53
  33.5%
IV (Light Brown)
48
  30.4%
V (Brown)
10
   6.3%
VI (Dark Brown)
10
   6.3%
1.Primary Outcome
Title Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 2-level Responders
Hide Description Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 2-levels of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from "0" (None) to "4" (Severe). A 2-level responder is a participant with a reduction in severity of at least 2-levels from Baseline at that particular visit. Number of participants analyzed is determined by observed participants at each visit.
Time Frame Day 22, 43, 90, and 180
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness Population
Arm/Group Title Collagenase Clostridium Histolyticum (CCH)
Hide Arm/Group Description:
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
Overall Number of Participants Analyzed 144
Measure Type: Count of Participants
Unit of Measure: Participants
At Least One of two areas (Left & Right): Day 22 Number Analyzed 137 participants
Yes
6
   4.4%
No
131
  95.6%
At Least One of two areas (Left & Right): Day 43 Number Analyzed 133 participants
Yes
8
   6.0%
No
125
  94.0%
At Least One of two areas (Left & Right): Day 90 Number Analyzed 127 participants
Yes
17
  13.4%
No
110
  86.6%
At Least One of two areas (Left & Right): Day 180 Number Analyzed 131 participants
Yes
20
  15.3%
No
111
  84.7%
2.Secondary Outcome
Title Investigator Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 1-level Responders
Hide Description Percentage of responders defined as participants with an improvement in cellulite severity from baseline of at least 1-level of severity of at least one buttock (left or right) on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) with ratings ranging from "0" (None) to "4" (Severe). A 1-level responder is a participant with a reduction in severity of at least 1-level from Baseline at that particular visit. Percentages are based on the observed counts. Number of participants analyzed is determined by observed participants at each visit.
Time Frame Day 22, 43, 90, and 180
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness Population
Arm/Group Title Collagenase Clostridium Histolyticum (CCH)
Hide Arm/Group Description:
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
Overall Number of Participants Analyzed 144
Measure Type: Count of Participants
Unit of Measure: Participants
At Least One of Two Areas (Left & Right): Day 22 Number Analyzed 137 participants
Yes
55
  40.1%
No
82
  59.9%
At Least One of Two Areas (Left & Right): Day 43 Number Analyzed 133 participants
Yes
87
  65.4%
No
46
  34.6%
At Least One of Two Areas (Left & Right): Day 90 Number Analyzed 127 participants
Yes
96
  75.6%
No
31
  24.4%
At Least One of Two Areas (Left & Right): Day 180 Number Analyzed 131 participants
Yes
90
  68.7%
No
41
  31.3%
3.Secondary Outcome
Title Subject Satisfaction With Cellulite Treatment Assessment at End of Study
Hide Description At Day 180, participants rated their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings range from Very Satisfied with Treatment (2), Satisfied with Treatment (1), Neither Dissatisfied nor Satisfied with Treatment (0), Dissatisfied with Treatment (-1), and Very Dissatisfied with Treatment (-2). Percentages are based on the observed counts.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed is the number participants in effectiveness population at Day 180.
Arm/Group Title Collagenase Clostridium Histolyticum (CCH)
Hide Arm/Group Description:
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
Overall Number of Participants Analyzed 130
Measure Type: Count of Participants
Unit of Measure: Participants
Very Satisfied with Treatment (2)
25
  19.2%
Satisfied with Treatment (1)
48
  36.9%
Neither Dissatisfied nor Satisfied with Treatment
32
  24.6%
Dissatisfied with Treatment (-1)
12
   9.2%
Very Dissatisfied with Treatment (-2)
13
  10.0%
4.Other Pre-specified Outcome
Title Overall Anti-AUX-I Serum Antibody by Visit
Hide Description Percent of participants that are seropositive. Descriptive statistics were based on log10 transformation of titer levels. Percentages were based on the number of subjects who had immunogenicity lab samples drawn at the visit. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Time Frame Day 1 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Collagenase Clostridium Histolyticum (CCH)
Hide Arm/Group Description:
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
Overall Number of Participants Analyzed 158
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-AUX-I: Day 1 Number Analyzed 156 participants
Seropositive
4
   2.6%
Seronegative
152
  97.4%
Anti-AUX-I: Day 22 Number Analyzed 147 participants
Seropositive
104
  70.7%
Seronegative
43
  29.3%
Anti-AUX-I: Day 43 Number Analyzed 143 participants
Seropositive
141
  98.6%
Seronegative
2
   1.4%
Anti-AUX-I: Day 90 Number Analyzed 134 participants
Seropositive
134
 100.0%
Seronegative
0
   0.0%
Anti-AUX-I: Day 180 Number Analyzed 135 participants
Seropositive
134
  99.3%
Seronegative
1
   0.7%
5.Other Pre-specified Outcome
Title Overall Anti-AUX-I Antibody Log Titer Levels by Visit
Hide Description Descriptive statistics were based on log10 transformation of titer levels. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Time Frame Day 1 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Collagenase Clostridium Histolyticum (CCH)
Hide Arm/Group Description:
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
Overall Number of Participants Analyzed 158
Mean (Standard Deviation)
Unit of Measure: log 10 titer
Anti-AUX-I: Day 1 positive Number Analyzed 4 participants
2.046  (1.012)
Anti-AUX-I: Day 22 positive Number Analyzed 104 participants
2.268  (1.076)
Anti-AUX-I: Day 43 positive Number Analyzed 141 participants
4.681  (0.924)
Anti-AUX-I: Day 90 positive Number Analyzed 134 participants
5.937  (0.686)
Anti-AUX-I: Day 180 positive Number Analyzed 134 participants
5.556  (0.981)
6.Other Pre-specified Outcome
Title Overall Anti-AUX-II Serum Antibody by Visit
Hide Description Percent of participants that are seropositive. Descriptive statistics were based on log10 transformation of titer levels. Percentages were based on the number of subjects who had immunogenicity lab samples drawn at the visit. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Time Frame Day 1 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Collagenase Clostridium Histolyticum (CCH)
Hide Arm/Group Description:
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
Overall Number of Participants Analyzed 158
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-AUX-I: Day 1 Number Analyzed 156 participants
Seropositive
6
   3.8%
Seronegative
150
  96.2%
Anti-AUX-I: Day 22 Number Analyzed 148 participants
Seropositive
50
  33.8%
Seronegative
98
  66.2%
Anti-AUX-I: Day 43 Number Analyzed 143 participants
Seropositive
138
  96.5%
Seronegative
5
   3.5%
Anti-AUX-I: Day 90 Number Analyzed 131 participants
Seropositive
131
 100.0%
Seronegative
0
   0.0%
Anti-AUX-I: Day 180 Number Analyzed 135 participants
Seropositive
130
  96.3%
Seronegative
5
   3.7%
7.Other Pre-specified Outcome
Title Overall Anti-AUX-II Antibody Log Titer Levels by Visit
Hide Description Descriptive statistics were based on log10 transformation of titer levels. Overall number of participants analyzed is determined by the number of participants in the study. At each visit, the number of participants analyzed is determined by observed participants that had a seropositive sample.
Time Frame Day 1 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Collagenase Clostridium Histolyticum (CCH)
Hide Arm/Group Description:
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
Overall Number of Participants Analyzed 158
Mean (Standard Deviation)
Unit of Measure: log 10 titer
Anti-AUX-II: Day 1 positive Number Analyzed 6 participants
1.607  (0.947)
Anti-AUX-II: Day 22 positive Number Analyzed 50 participants
1.942  (1.068)
Anti-AUX-II: Day 43 positive Number Analyzed 138 participants
3.641  (1.068)
Anti-AUX-II: Day 90 positive Number Analyzed 131 participants
5.255  (0.809)
Anti-AUX-II: Day 180 positive Number Analyzed 130 participants
5.141  (0.913)
8.Other Pre-specified Outcome
Title Anti-AUX-I Neutralizing Antibodies by Visit
Hide Description A subset of all CCH Treated participants who had positive binding antibody titer levels were tested for the presence or absence of Neutralizing Antibodies. Overall Number of Participants Analyzed is determined by the number of participants in the highest and lowest quartiles at Day 90 (Q1 and Q4) of seropositive participants at each of two visits (Day 90 and Day 180).
Time Frame Day 1 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Collagenase Clostridium Histolyticum (CCH)
Hide Arm/Group Description:
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
anti-AUX-I Neutralizing Antibody: Day 1 Number Analyzed 1 participants
Positive
0
   0.0%
Negative
1
 100.0%
anti-AUX-I Neutralizing Antibody: Day 90 Number Analyzed 34 participants
Positive
26
  76.5%
Negative
8
  23.5%
anti-AUX-I Neutralizing Antibody: Day 180 Number Analyzed 33 participants
Positive
19
  57.6%
Negative
14
  42.4%
9.Other Pre-specified Outcome
Title Anti-AUX-II Neutralizing Antibodies by Visit
Hide Description A subset of all CCH Treated participants who had positive binding antibody titer levels were tested for the presence or absence of Neutralizing Antibodies. Overall Number of Participants Analyzed is determined by the number of participants in the study. Number of Participants Analyzed is determined by observed participants that had a seropositive sample at each visit and the antibody level at Day 71 in Q1 and Q4.
Time Frame Day 1 to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Collagenase Clostridium Histolyticum (CCH)
Hide Arm/Group Description:
12 injections of CCH (Collagenase Clostridium Histolyticum) were administered per treatment area at each treatment visit during 3 visits.
Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
anti-AUX-II Neutralizing Antibodies: Day 1 Number Analyzed 1 participants
Positive
1
 100.0%
Negative
0
   0.0%
anti-AUX-II Neutralizing Antibodies: Day 90 Number Analyzed 32 participants
Positive
24
  75.0%
Negative
8
  25.0%
anti-AUX-II Neutralizing Antibodies: Day 180 Number Analyzed 31 participants
Positive
20
  64.5%
Negative
11
  35.5%
Time Frame All (serious and non-serious) AEs, from Day 1 up to Day 180
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.
 
Arm/Group Title Collagenase Clostridium Histolyticum (CCH)
Hide Arm/Group Description

EN3835 0.84mg (Collagenase Clostridium Histolyticum)

Collagenase Clostridium Histolyticum: During 3 treatment visits 12 injections is given per treatment area

All-Cause Mortality
Collagenase Clostridium Histolyticum (CCH)
Affected / at Risk (%)
Total   0/158 (0.00%) 
Hide Serious Adverse Events
Collagenase Clostridium Histolyticum (CCH)
Affected / at Risk (%)
Total   1/158 (0.63%) 
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  1  1/158 (0.63%) 
1
Term from vocabulary, MedDRA Version 19
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Collagenase Clostridium Histolyticum (CCH)
Affected / at Risk (%)
Total   158/158 (100.00%) 
General disorders   
Injection site bruising  1  136/158 (86.08%) 
Injection site pain  1  76/158 (48.10%) 
Injection site swelling  1  35/158 (22.15%) 
Injection site pruritus  1  27/158 (17.09%) 
Injection site discolouration  1  26/158 (16.46%) 
Injection site nodule  1  23/158 (14.56%) 
Injection site warmth  1  18/158 (11.39%) 
Injection site haemorrhage  1  17/158 (10.76%) 
Injection site mass  1  10/158 (6.33%) 
Skin and subcutaneous tissue disorders   
Hemosiderin stain  1  8/158 (5.06%) 
1
Term from vocabulary, MedDRA Version 19
Indicates events were collected by systematic assessment
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
Layout table for additonal information
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03329989    
Other Study ID Numbers: EN3835-205
First Submitted: October 31, 2017
First Posted: November 6, 2017
Results First Submitted: August 5, 2020
Results First Posted: November 23, 2020
Last Update Posted: December 29, 2020