NCT05322525

A Research Study to Evaluate the Safety and Potential Efficacy of ON101 Cream for the Treatment of Venous Leg Ulcers.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Oneness Biotech Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

A Research Study to evaluate the safety and potential efficacy of ON101 cream for the treatment of venous leg ulcers.The objectives of the study are to determine the safety and to explore the potential efficacy of ON101 cream in patients with venous leg ulcers.

Detailed description

This is a multi-center, open-label study to investigate the Safety and Potential Efficacy of ON101 Cream in Venous Leg Ulcers (VLU) patients. Subjects with VLU of CEAP C6 (active venous ulcer) or C6R (recurrent active venous ulcer) are to be included in this study. If a subject has more than one ulcer on the leg, the most severe ulcer then the largest ulcer that confirm to meet the eligibility criteria will be selected for study evaluation. 12 eligible subjects will be enrolled and receive ON101 cream treatment. Enrolled subjects will be instructed to apply the study treatment on the selected target ulcer for a maximum of 18 weeks, until the ulcer complete closure (ulcer size of 0) for two consecutive visits that at least 2 weeks apart, or until the subject exit the study prematurely due to any reason. Identical standard of care (SoC) procedure will be performed in both the control and investigational product arms throughout the study period, which including ulcer cleansing, debridement if necessary, and application of a suitable dressing and compression system until complete ulcer closure. Subjects are required to apply compression device at least 8 hours per day throughout the treatment period. The study consists of three periods, a 2-week Screening/Run-in period, an up-to-18-week Treatment period, and a 1-to-2-week Follow-up period. The Screening/Run-in period is to ensure the subjects' eligibility and their compliance to compression therapy and to exclude subjects who demonstrate substantial healing resulting solely from improved compliance with SoC. The Treatment period is to determine the safety and to explore the potential efficacy of the study product. The Follow-up period is to assess the safety. During the Follow-up period, SoC will be provided to subjects with non-healing or recurrent target ulcer.

Conditions

• Venous Leg Ulcers (VLU)

Interventions

Type	Name	Description
DRUG	ON101 Cream	Test drug: 1. Name: ON101 2. Dosage form: Topical cream 3. Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica 4. Dose(s): Apply 1 cc per 5 cm2 ulcer size (not exceeding 2 mm in thickness) 5. Dosing schedule: Apply once a day

Timeline

• Start date: 2021-06-23
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2022-04-12
• Last updated: 2025-03-12

Locations

2 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study