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

NCT05322525 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-03-12

No results posted yet for this study

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.

Conditions

  • Venous Leg Ulcers (VLU)

Interventions

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

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Taipei Medical University Shuang Ho Hospital

    collaborator OTHER

  • Oneness Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shyi-Gen Chen, MD · Oneness Biotech Co., Ltd.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-23
Primary Completion
2023-08-15
Completion
2023-08-15
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05322525 on ClinicalTrials.gov