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Clinical Trial Summary

This study will evaluate the safety and Pharmacokinetics (PK) of a single 3.36-mg dose of Collagenase Clostridium Histolyticum (CCH) in 4 quadrants concurrently, in subjects with Edematous fibrosclerotic panniculopathy (EFP).

This study will provide insight to the PK profile and safety of concurrent subcutaneous injections of CCH 0.84 mg/quadrant into 4 quadrants.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Edema
  • Edematous Fibrosclerotic Panniculopathy

NCT number NCT03675685
Study type Interventional
Source Endo Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date September 18, 2018
Completion date November 1, 2018

See also
  Status Clinical Trial Phase
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 NCT03893890 - Durability and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women
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