Phase 2
N=259
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Edematous Fibrosclerotic Panniculopathy · Cellulite
Bottom Line
View on ClinicalTrials.gov: NCT02942160 ↗Enrolled (actual)
259
Serious AEs
1.1%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase — 19; 0; 16; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Collagenase Clostridium Histolyticum (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Endo Pharmaceuticals
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase |
19; 0; 16; 0 | — |
| SECONDARY Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase |
50; 3; 43; 2 | — |
| SECONDARY Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase |
7; 0; 7; 0 | — |
| SECONDARY Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase |
22; 1; 21; 2 | — |
| SECONDARY CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase |
-0.8; -0.3; -0.6; -0.2; -0.6; -0.1 | — |
| SECONDARY CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment |
-0.6; -0.8; -1.0; -1.0; -0.9 | — |
| SECONDARY PR-PCSS Change From Baseline by Visit in Treatment Phase for Participants With Second EN3835 Treatment |
-0.5; -0.8; -1.1; -1.0; -1.0 | — |
| SECONDARY Change From Baseline on the Hexsel CSS Total Score During the Observation Phase |
10.7; 10.4; 9.0; 9.7; -1.8; -0.8 | — |
| SECONDARY Change From Baseline (BL) in the Hexsel CSS Total Score During Long-term Durability Visits |
10.6; -3.5; -2.9 | — |
| SECONDARY Change From Baseline in Hexsel CSS Total Score in Treatment Phase for Participants With Second EN3835 Treatment |
10.5; 8.3; -2.2; 8.1; -2.4 | — |
| SECONDARY Investigator Global Aesthetic Improvement Scale (I-GAIS) at Observation Visit Day 360 During the Observation Phase |
4; 0; 23; 0; 36; 4 | — |
| SECONDARY Investigator Global Aesthetic Improvement Scale (I-GAIS) in Treatment Phase for Participants With Second EN3835 Treatment |
10; 38; 73; 35; 3; 0 | — |
| SECONDARY Subject Global Aesthetic Improvement Scale (S-GAIS) at the End of Study (EOS) During the Observation Phase, Observation Visit Day 360 |
3; 0; 18; 0; 46; 4 | — |
| SECONDARY Subject Global Aesthetic Improvement Scale (S-GAIS) During the Treatment Phase for Participants With Second EN3835 Treatment |
16; 33; 69; 32; 7; 1 | — |
| SECONDARY Subject Satisfaction With EFP Treatment at the End of Study (EOS) in Observation Phase, Observation Visit Day 360 |
14; 0; 41; 4; 23; 11 | — |
| SECONDARY Subject Satisfaction With EFP Treatment in Treatment Phase for Subjects With Second EN3835 Treatment |
34; 67; 36; 13; 9; 25 | — |
Summary
A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).
Eligibility Criteria
Inclusion Criteria for Observation Phase:
- Voluntarily sign and date an informed consent agreement
- Have participated in and completed the double-blind study EN3835-201
- Be willing to apply sunscreen to any treated quadrant before each exposure to sun
Inclusion Criteria for Treatment Phase:
- Voluntarily sign and date an informed consent agreement
- Have participated in and completed the double-blind study EN3835-201
- Be willing to apply sunscreen to any treated quadrant before each exposure to sun
- Have at least 1 quadrant with: a score of 3 or 4 (moderate or severe) as reported on the PCSS (Photonumeric Cellulite Severity Scale) by the subject or investigator, and a Hexsel CSS (Cellulite Severity Scale) score no greater than 13
- Be judged to be in good health
- Have a negative urine pregnancy test at screening and be using an effective contraception method, be surgically sterile, or post-menopausal
Exclusion Criteria for Observation Phase:
- None
Exclusion Criteria for Treatment Phase:
- Has used, or intends to use during the course of the study, other treatment of EFP on the legs or buttocks
- Is presently nursing a baby or providing breast milk for a baby
- Intends to become pregnant during the study
- Currently receiving, has received within 7 days before injection of study drug, or plans to receive an anticoagulant or antiplatelet medication
- History of stroke or bleeding
Data sourced from ClinicalTrials.gov (NCT02942160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.