NCT04236635

Histopathology Following CCH Injection

A Phase 2B, Open-Label Study to Explore Tissue Histopathology Following Subcutaneous Injection of Collagenase Clostridium Histolyticum Using An Abdominoplasty Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the histopathology of subcutaneous tissue isolated after single or multiple Collagenase Clostridium Histolyticum (CCH) injection techniques in adult female participants undergoing abdominoplasty.

Conditions

• Characteristics of Subcutaneous Tissue

Interventions

Type	Name	Description
DRUG	Collagenase Clostridium Histolyticum Single Injection Technique	CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg.
DRUG	Collagenase Clostridium Histolyticum Multiple Injection Technique	CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg.

Timeline

• Start date: 2019-12-20
• Primary completion: 2020-09-23
• Completion: 2020-10-26
• First posted: 2020-01-22
• Last updated: 2022-04-12
• Results posted: 2022-04-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study