Trials / Terminated
TerminatedNCT04962139
Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Phase-III Study to Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Oneness Biotech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary efficacy endpoint for this study is the proportion of subjects with complete closure of Target Ulcer during the 20-week Treatment Phase, which is assessed by the blinded independent evaluator.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ON101 Cream | Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica |
| OTHER | Vehicle Cream | ON101 Cream Placebo |
Timeline
- Start date
- 2021-07-27
- Primary completion
- 2022-11-01
- Completion
- 2022-11-29
- First posted
- 2021-07-14
- Last updated
- 2025-03-13
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04962139. Inclusion in this directory is not an endorsement.