NCT03632993

Injection Techniques of Collagenase Clostridium Histolyticum (CCH) for the Treatment of EFP (Cellulite)

A Phase 2A, Open-Label Study Evaluating the Safety and Different Injection Techniques of CCH for the Treatment of Edematous Fibrosclerotic Panniculopathy (EFP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the safety and effectiveness of different injection techniques of Collagenase Clostridium Histolyticum (CCH) for the treatment of adult women with mild, moderate or severe Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).

Conditions

• Edematous Skin

Interventions

Type	Name	Description
DRUG	collagenase clostridium histolyticum (CCH)	Endo Pharmaceuticals Inc. (Endo) is developing collagenase clostridium histolyticum (CCH) for the treatment of EFP. Because CCH is a proteinase that can hydrolyze the triple-helical region of collagen under physiological conditions, CCH has the potential to be effective in lysing sub-dermal collagen, such as those observed in the dermal septa, which are the underlying cause of the skin dimpling in women with Edematous Fibrosclerotic Panniculopathy (EFP). CCH targets the collagenase structural matrix (for example, dermal septa) at the site of injection and does not require systemic exposure to be effective.

Timeline

• Start date: 2018-09-18
• Primary completion: 2019-01-24
• Completion: 2019-01-24
• First posted: 2018-08-16
• Last updated: 2023-09-07
• Results posted: 2023-09-07

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study