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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Edema
  • Edematous Fibrosclerotic Panniculopathy

NCT number NCT03893890
Study type Observational
Source Endo Pharmaceuticals
Contact
Status Completed
Phase
Start date March 28, 2019
Completion date June 25, 2019

See also
  Status Clinical Trial Phase
Completed NCT03675685 - Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP Phase 1
Completed NCT02942160 - EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) Phase 2
Completed NCT04580303 - CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques Phase 2
Completed NCT03329989 - Safety and Effectiveness of EN3835 in the Treatment of EFP in Women Phase 2
Completed NCT04381117 - Long-term Durability Study of Collagenase Clostridium Histolyticum (CCH)
Completed NCT05419505 - Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks Phase 2
Completed NCT05249257 - Durability and Safety of CCH With Two Different Injection Techniques in Cellulite With Laxity
Completed NCT01518907 - The Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) Phase 1
Completed NCT02724644 - EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) Phase 2
Completed NCT03526549 - Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite) Phase 3