drugset / Trial / NCT04170296

Real World CCH Study in Adult Females With Cellulite

NCT04170296

Phase 3 Completed 153 enrolled Endo USA Inc., a Keenova Therapeutics Company
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP). Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or moderate EFP in the buttocks.

Timeline

Start
2019-11-01
Primary completion
2020-10-06
Completion
2021-01-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic 1.68 mg