NCT00155337

Brief Summary

Photodynamic therapy for oral leukoplakia and erythroleukoplakia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 21, 2012

Status Verified

December 1, 2012

Enrollment Period

3.3 years

First QC Date

September 8, 2005

Last Update Submit

December 20, 2012

Conditions

Oral Leukoplakia

Keywords

leukoplakiaerythroleukoplakiaphotodynamic therapy

Outcome Measures

Primary Outcomes (1)

  • End of 8 treatments

Secondary Outcomes (1)

  • Regression of lesions

Interventions

photodynamic therapyPROCEDURE

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with leukoplakia or erythroleukoplakia

You may not qualify if:

  • oral cancers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Leukoplakia, OralLeukoplakia

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Mouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPrecancerous ConditionsMouth DiseasesStomatognathic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Chun-Pin Chiang, DMSc

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

December 21, 2012

Record last verified: 2012-12

Locations

TW(1)