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

NCT03329989 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2020-12-29

Study results available
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Summary

An open-label study of safety and effectiveness of EN3835 in the treatment of cellulite in adult women.

Conditions

  • Edematous Fibrosclerotic Panniculopathy
  • Cellulite

Interventions

BIOLOGICAL

Collagenase Clostridium Histolyticum

During 3 treatment visits 12 injections will be given per treatment area

Sponsors & Collaborators

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Mike McLane, PhD · Endo Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-17
Primary Completion
2018-09-05
Completion
2018-09-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03329989 on ClinicalTrials.gov