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A Study to Evaluate the Efficacy and Safety of Radion™-Pdt in Patients With Oral Precancerous Lesion

NCT03279744 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-01-02

No results posted yet for this study

Summary

A Prospective, Single-Arm, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Photodynamic Therapy Using Radion™-pdt in Patients with Oral Precancerous Lesion (Oral Verrucous Hyperplasia or Oral Erythroleukoplakia).

Conditions

  • Erythroleukoplakia of Mouth
  • Verrucous Hyperplasia of Oral Mucosa

Interventions

DRUG

Radion™-pdt

The Radion™-pdt will be applied topically to the lesion. The Radion™-pdt applied dosage is about 0.1 mL/cm\^2 and properly cover the entire lesion.

Sponsors & Collaborators

  • Pharma Power Biotec Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hsin-Ming Chen · National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-06
Primary Completion
2019-09-04
Completion
2019-12-20

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 NCT03279744 on ClinicalTrials.gov