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Photodynamic Therapy for Oral Leukoplakia and Erythroleukoplakia

Primary Purpose

Oral Leukoplakia

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
photodynamic therapy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Leukoplakia focused on measuring leukoplakia, erythroleukoplakia, photodynamic therapy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients with leukoplakia or erythroleukoplakia Exclusion Criteria: oral cancers

Sites / Locations

  • National Taiwan University Hospital

Outcomes

Primary Outcome Measures

End of 8 treatments

Secondary Outcome Measures

Regression of lesions

Full Information

First Posted
September 8, 2005
Last Updated
December 20, 2012
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00155337
Brief Title
Photodynamic Therapy for Oral Leukoplakia and Erythroleukoplakia
Official Title
Photodynamic Therapy for Oral Leukoplakia and Erythroleukoplakia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

Brief Summary
Photodynamic therapy for oral leukoplakia and erythroleukoplakia
Detailed Description
Photodynamic therapy for oral leukoplakia and erythroleukoplakia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Leukoplakia
Keywords
leukoplakia, erythroleukoplakia, photodynamic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
photodynamic therapy
Primary Outcome Measure Information:
Title
End of 8 treatments
Secondary Outcome Measure Information:
Title
Regression of lesions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with leukoplakia or erythroleukoplakia Exclusion Criteria: oral cancers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Pin Chiang, DMSc
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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Photodynamic Therapy for Oral Leukoplakia and Erythroleukoplakia

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