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A Randomized,Double-blind,Placebo-controlled Clinical Study to Explore the Mechanism of Action of ON101 Cream in Patients With DFUs.

NCT04945161 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-01-05

No results posted yet for this study

Summary

The primary objective is to explore the mechanistic role of ON101 cream in healing diabetic foot ulcers by determining the molecular targets of ON101 cream.

Primary endpoint:

Percentage change from baseline in the expression level of individual target gene(s) at protein and/or mRNA level.

Secondary endpoints:

1. Comparison of the gene and/or protein expression level of individual target between ON101 and Placebo groups
2. Change from baseline in the wound microbiota composition in each group
3. Comparison of the wound microbiota composition between ON101 and Placebo groups
4. Comparison of the wound reduction rate in each group
5. Correlation of wound reduction rate with the alternated level of each target gene in each group.

Safety endpoints:

Incidence of treatment-emergent adverse event (AE) Change from baseline in vital signs, physical examination, and laboratory tests

Conditions

  • Diabetic Foot Ulcers

Interventions

DRUG

ON101 Cream

Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Oneness Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-23
Primary Completion
2021-11-09
Completion
2021-12-24

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 NCT04945161 on ClinicalTrials.gov