NCT04078555

A Study to Evaluate ENERGI-F703 GEL in Venous Leg Ulcer

A Randomized, Double-Blind, Placebo-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F703 GEL in Subjects With Venous Leg Ulcer (VLU)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Energenesis Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, phase II, multi-centered study to evaluate the efficacy and safety of ENERGI-F703 GEL in subjects who are ≥ 20 years old with venous leg ulcer (VLU). Subjects will be recruited from multiple sites in Taiwan. The treatment period will be 84 days with another 84-day follow-up period.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DRUG	ENERGI-F703 GEL	The study medication will be applied twice daily until the end of 84 days or up to the visit confirmation of complete ulcer closure, whichever comes first. The estimated amount of study medication applied to the ulcer area is 0.25 cm (about 0.11 g) in length per cm2 of ulcer size.
DRUG	ENERGI-F703 GEL matched vehicle	The study medication will be applied twice daily until the end of 84 days or up to the visit confirmation of complete ulcer closure, whichever comes first. The estimated amount of study medication applied to the ulcer area is 0.25 cm (about 0.11 g) in length per cm2 of ulcer size.

Timeline

• Start date: 2022-07-26
• Primary completion: 2025-03-15
• Completion: 2025-06-15
• First posted: 2019-09-06
• Last updated: 2024-02-20

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study