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Durability and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women

NCT03893890 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2019-07-19

No results posted yet for this study

Summary

This is a Phase 2b, rollover, long-term study to evaluate the safety and duration of efficacy of EN3835 in the treatment of women with EFP. Subjects who participated in and completed studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201 will be eligible for this study.

Conditions

  • Edematous Fibrosclerotic Panniculopathy

Interventions

BIOLOGICAL

Previously Treated with EN3835

No treatment to be administered - Observational only

Sponsors & Collaborators

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Karen Chajko · Endo Pharmaceuticals

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2019-06-25
Completion
2019-06-25
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 NCT03893890 on ClinicalTrials.gov