18 and older, female only, with Edematous Fibrosclerotic Panniculopathy (Cellulite). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
2-level Composite Responders for the Target ButtockPrimary· Day 71
Proportion of 2-level Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) / Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) composite responders in the target buttock at Day 71. CR-PCSS and PR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is defined as a participant with improvement from baseline of at least 2-levels of severity in the CR-PCSS and an improvement from baseline of at least 2-levels of severity in the PR-PCSS of the target buttock. A participant who missed one or two assessments of CR-PCSS and PR-PCS
Group
Value
95% CI
Collagenase Clostridium Histolyticum (CCH)
12
Placebo
1
Collagenase Clostridium Histolyticum (CCH)
202
Placebo
205
1-level PR-PCSS Responders of the Target ButtockSecondary· Day 71
Improvement in cellulite severity of the Target Buttock from baseline of at least 1-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS). PR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).
Group
Value
95% CI
Collagenase Clostridium Histolyticum (CCH)
124
Placebo
61
Collagenase Clostridium Histolyticum (CCH)
90
Placebo
145
2-level PR-PCSS Responders of the Target ButtockSecondary· Day 71
Improvement in cellulite severity of the Target Buttock from baseline of at least 2-levels of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS). PR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).
Group
Value
95% CI
Collagenase Clostridium Histolyticum (CCH)
45
Placebo
12
Collagenase Clostridium Histolyticum (CCH)
169
Placebo
194
1-level Composite Responders of the Target ButtockSecondary· Day 71
Improvement in cellulite severity of the Target Buttock from baseline of at least 1-level of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) / Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS). PR-PCSS and CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).
Group
Value
95% CI
Collagenase Clostridium Histolyticum (CCH)
89
Placebo
23
Collagenase Clostridium Histolyticum (CCH)
125
Placebo
183
2-level Composite Responders of the Non-target ButtockSecondary· Day 71
Improvement in cellulite severity of the Non-target Buttock from baseline of at least 2-levels of severity in Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) / Clinician -Reported Photonumeric Cellulite Severity Scale (CR-PCSS). PR-PCSS and CR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe).
Group
Value
95% CI
Collagenase Clostridium Histolyticum (CCH)
13
Placebo
4
Collagenase Clostridium Histolyticum (CCH)
201
Placebo
202
1-level SSRS RespondersSecondary· Day 71
Subject Self-Rating Scale (SSRS) is a measure that assesses participant satisfaction with appearance in association with cellulite on the buttocks using whole numbers on a 7-level scale that ranges from "0" (Extremely Dissatisfied) to "6" (Extremely Satisfied). A 1-level SSRS responder is defined as a participant who is at least slightly satisfied (Slightly Satisfied \[4\], Very Satisfied \[5\], or Extremely Satisfied \[6\]) with the appearance of the cellulite on her buttocks at Day 71.
Group
Value
95% CI
Collagenase Clostridium Histolyticum (CCH)
90
Placebo
31
Change From Baseline in PR-CIS Total ScoreSecondary· Day 71
Patient-Reported Cellulite Impact Scale (PR-CIS) is a 6-item static questionnaire, each item is answered by a participant on a 11-level numerical rating scale that ranges from "0" (Not at all) to "10" (Extremely). The PR-CIS total score is the sum of individual item scores and can range from "0" to "60" with higher numbers reflecting a more negative impact from the cellulite. A responder is defined as a participant with a reduction in the PR-CIS total score of at least 12 from baseline at evaluation time point. A negative change from baseline indicates an improvement in cellulite severity.
Baseline (Day 1)
Group
Value
95% CI
Collagenase Clostridium Histolyticum (CCH)
52.4
± 8.01
Placebo
51.6
± 9.40
Day 71
Group
Value
95% CI
Collagenase Clostridium Histolyticum (CCH)
40.9
± 13.57
Placebo
45.1
± 12.65
Change from Baseline
Group
Value
95% CI
Collagenase Clostridium Histolyticum (CCH)
-11.5
± 12.74
Placebo
-6.5
± 11.74
1-level S-GAIS Responders of Target ButtockSecondary· Day 71
Subject Global Aesthetic Improvement Scale (S-GAIS) is a measure that assesses participant rating of cellulite appearance after treatment. This scale has 7-levels ranging from "+3" (Very Much Improved) to "-3" (Very Much Worse). Responders are defined as participants with ≥1-level improvement (Improved, Much Improved or Very Improved) in S-GAIS assessment of the Target Buttock.
Group
Value
95% CI
Collagenase Clostridium Histolyticum (CCH)
126
Placebo
46
2-level S-GAIS Responders of Target ButtockSecondary· Day 71
Subject Global Aesthetic Improvement Scale (S-GAIS) is a measure that assesses participant rating of cellulite appearance after treatment. This scale has 7-levels ranging from "+3" (Very Much Improved) to "-3" (Very Much Worse). Responders are defined as participants with ≥ 2-level improvement (Much Improved or Very Much Improved) in S-GAIS assessment of the Target Buttock.
Group
Value
95% CI
Collagenase Clostridium Histolyticum (CCH)
38
Placebo
9
PR-PCSS Rating for the Target and Non-target Buttock by VisitSecondary· Day 71
The Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level photonumeric scale used by the patient (participant) to assess the severity of the participant's cellulite. The ratings range from "0" (None) to "4" (Severe).
Target Buttock Rating
Group
Value
95% CI
Day 1: CCH
0
Day 1: Placebo
0
Day 22: CCH
0
Day 22: Placebo
1
Day 43: CCH
0
Day 43: Placebo
0
Day 71: CCH
3
Day 71: Placebo
0
Day 71: CCH (LOCF)
3
Day 71: Placebo (LOCF)
0
Day 1: CCH
0
Day 1: Placebo
0
Day 22: CCH
1
Day 22: Placebo
1
Day 43: CCH
17
Day 43: Placebo
3
Day 71: CCH
19
Day 71: Placebo
2
Day 71: CCH (LOCF)
19
Day 71: Placebo (LOCF)
2
Day 1: CCH
0
Day 1: Placebo
0
Day 22: CCH
45
Day 22: Placebo
17
Day 43: CCH
61
Day 43: Placebo
26
Day 71: CCH
61
Day 71: Placebo
32
Day 71: CCH (LOCF)
64
Day 71: Placebo (LOCF)
32
Day 1: CCH
89
Day 1: Placebo
82
Day 22: CCH
78
Day 22: Placebo
79
Day 43: CCH
67
Day 43: Placebo
85
Day 71: CCH
65
Day 71: Placebo
76
Day 71: CCH (LOCF)
76
Day 71: Placebo (LOCF)
81
Non-target Buttock Rating
Group
Value
95% CI
Day 1: CCH
0
Day 1: Placebo
0
Day 22: CCH
0
Day 22: Placebo
1
Day 43: CCH
0
Day 43: Placebo
0
Day 71: CCH
1
Day 71: Placebo
0
Day 71: CCH (LOCF)
1
Day 71: Placebo (LOCF)
0
Day 1: CCH
0
Day 1: Placebo
0
Day 22: CCH
3
Day 22: Placebo
0
Day 43: CCH
17
Day 43: Placebo
4
Day 71: CCH
21
Day 71: Placebo
3
Day 71: CCH (LOCF)
21
Day 71: Placebo (LOCF)
3
Day 1: CCH
0
Day 1: Placebo
0
Day 22: CCH
38
Day 22: Placebo
19
Day 43: CCH
55
Day 43: Placebo
24
Day 71: CCH
58
Day 71: Placebo
32
Day 71: CCH (LOCF)
64
Day 71: Placebo (LOCF)
34
Day 1: CCH
96
Day 1: Placebo
71
Day 22: CCH
82
Day 22: Placebo
71
Day 43: CCH
67
Day 43: Placebo
86
Day 71: CCH
66
Day 71: Placebo
72
Day 71: CCH (LOCF)
74
Day 71: Placebo (LOCF)
75
Subjects Satisfaction With Cellulite TreatmentSecondary· Day 71
A 1-level Subject Satisfaction Responder is defined as a participant who is at least satisfied (Satisfied \[+1\], or Very Satisfied \[+2\]) with the appearance of the cellulite on her buttocks at the Day 71 visit. A positive change indicates an improvement in cellulite.
Group
Value
95% CI
Day 71: CCH
15
Day 71: Placebo
4
Day 71: CCH (LOCF)
15
Day 71: Placebo (LOCF)
4
Day 71: CCH
72
Day 71: Placebo
22
Day 71: CCH (LOCF)
74
Day 71: Placebo (LOCF)
22
Day 71: CCH
60
Day 71: Placebo
73
Day 71: CCH (LOCF)
64
Day 71: Placebo (LOCF)
75
Day 71: CCH
24
Day 71: Placebo
47
Day 71: CCH (LOCF)
29
Day 71: Placebo (LOCF)
48
Serum Antibody Positivity by VisitSecondary· Day 1 - Day 71
Percent of participants that are seropositive. Percentages were based on the number of subjects who had immunogenicity lab samples analyzed at the visit.
Day 1
Group
Value
95% CI
Anti-AUX-I: CCH
6
Anti-AUX-I: Placebo
2
Anti-AUX-II: CCH
3
Anti-AUX-II: Placebo
6
Anti-AUX-I: CCH
208
Anti-AUX-I: Placebo
204
Anti-AUX-II: CCH
211
Anti-AUX-II: Placebo
200
Day 22
Group
Value
95% CI
Anti-AUX-I: CCH
106
Anti-AUX-I: Placebo
1
Anti-AUX-II: CCH
52
Anti-AUX-II: Placebo
7
Anti-AUX-I: CCH
90
Anti-AUX-I: Placebo
198
Anti-AUX-II: CCH
144
Anti-AUX-II: Placebo
192
Day 43
Group
Value
95% CI
Anti-AUX-I: CCH
183
Anti-AUX-I: Placebo
4
Anti-AUX-II: CCH
183
Anti-AUX-II: Placebo
7
Anti-AUX-I: CCH
3
Anti-AUX-I: Placebo
186
Anti-AUX-II: CCH
3
Anti-AUX-II: Placebo
183
Day 71
Group
Value
95% CI
Anti-AUX-I: CCH
186
Anti-AUX-I: Placebo
8
Anti-AUX-II: CCH
185
Anti-AUX-II: Placebo
9
Anti-AUX-I: CCH
0
Anti-AUX-I: Placebo
182
Anti-AUX-II: CCH
1
Anti-AUX-II: Placebo
181
Adverse events — posted to ClinicalTrials.gov
Time frame: All (serious and nonserious) AEs, from Day 1 to Day 71.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Subjects will be screened for study eligibility within 14 days prior to enrolling in this study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of cellulite as independently assessed by the subject using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) and by the Investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) will be eligible. The eligibility of the buttocks will be confirmed on Day 1. Once the eligibility of the buttocks is confirmed, subjects will be randomly assigned to a treatment group (EN3835 0.84 mg per buttock or placebo) in a 1:1 ratio within an investigational site. Each subject will receive a treatment course which consists of up to 3 treatment visits (sessions), separated by 21 days (ie, Days 1, 22, and 43). Each treatment visit will consist of 12 injections (0.3 mL per injection of EN3835 0.07 mg/injection or placebo; 0.84 mg in 3.6 mL per buttock) in each of the two buttocks for a total volume of 7.2 mL (1.68 mg). Selection of dimples to be treated in the buttocks will be at the discretion of the Investigator. End of study will occur at study day 71.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Endo Pharmaceuticals
Last refreshed: 8 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03446781.