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Collagenase
Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Women
Phase 2
Waitlist Available
Research Sponsored by Endo Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 22, day 43 and day 71
Awards & highlights
No Placebo-Only Group
Summary
This is a single center, open-label, Phase 2a study to assess the photonumeric scale, morphological, and histopathological changes associated with Collagenase Clostridium Histolyticum (CCH) in adult women with moderate or severe Edematous Fibrosclerotic Panniculopathy (EFP).
Eligible Conditions
- Cellulite
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 22, day 43 and day 71
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 22, day 43 and day 71
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The Change From Baseline (Screening) in PR-PCSS
Secondary study objectives
Histopathology Before and After CCH Treatment
MRI Before and After CCH Treatment
The Change From Baseline (Screening) in CR-PCSS
+1 moreSide effects data
From 2021 Phase 3 trial • 153 Patients • NCT0417029693%
Injection site bruising
79%
Injection site pain
33%
Injection site discolouration
19%
Injection site pruritus
18%
Injection site swelling
7%
Injection site mass
7%
Injection site nodule
7%
Injection site oedema
3%
Post-inflammatory pigmentation change
3%
Injection site haemorrhage
1%
Oropharyngeal pain
1%
Injection site dermatitis
1%
Urinary tract infection
1%
Blood potassium increased
1%
Nitrite urine present
1%
Pyrexia
1%
Coronavirus test positive
1%
Urine leukocyte esterase positive
1%
White blood cell count increased
1%
Diffuse alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: Buttocks
Cohort 1: Posterolateral Thigh
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Buttock & Posterolateral ThighExperimental Treatment1 Intervention
EN3835 up to 1.68 mg (Collagenase Clostridium Histolyticum)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EN3835
2019
Completed Phase 3
~1770
Find a Location
Who is running the clinical trial?
Endo PharmaceuticalsLead Sponsor
135 Previous Clinical Trials
33,694 Total Patients Enrolled
17 Trials studying Cellulite
2,748 Patients Enrolled for Cellulite
Ashley DayoubStudy DirectorEndo Pharmaceuticals