Oral LeukoplakiaPhase 4NCT00155337
Photodynamic Therapy for Oral Leukoplakia and Erythroleukoplakia
A Phase 4 study testing photodynamic therapy in people with Oral Leukoplakia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Photodynamic therapy for oral leukoplakia and erythroleukoplakia Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Oral Leukoplakia
- What is being tested?
- photodynamic therapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2004to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with leukoplakia or erythroleukoplakia
Who cannot join
- oral cancers
Trial locations and contacts
1 site in 1 country.
About this study
Photodynamic therapy for oral leukoplakia and erythroleukoplakia
Read the detailed description
Photodynamic therapy for oral leukoplakia and erythroleukoplakia
- Conditions
- Oral Leukoplakia
- Being tested
- photodynamic therapy
- Keywords
- leukoplakia, erythroleukoplakia, photodynamic therapy
- Medical subject headings
- Leukoplakia, Oral, Leukoplakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photodynamic therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
End of 8 treatments
Secondary outcomes (1)
Regression of lesions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral LeukoplakiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chun-Pin Chiang, DMSc, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155337
- Sponsor's protocol ID
- 9361700753
- Status last verified
- Dec 2012
- First submitted
- 8 Sep 2005
- Last updated
- 21 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy for Oral Leukoplakia and Erythroleukoplakia
- ClinicalTrials.gov ID
- NCT00155337
- Acronym / sponsor ID
- 9361700753
- Conditions
- Oral Leukoplakia
- Keywords
- leukoplakia, erythroleukoplakia, photodynamic therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Photodynamic therapy for oral leukoplakia and erythroleukoplakia
Detailed description
Photodynamic therapy for oral leukoplakia and erythroleukoplakia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with leukoplakia or erythroleukoplakia
Key exclusion criteria (1 listed)
- oral cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photodynamic therapy | Procedure or surgery | – |
Primary outcome
End of 8 treatments
1 secondary outcome
Regression of lesions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
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Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
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Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
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Oral Leukoplakia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Pin Chiang, DMSc principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing photodynamic therapy in people with Oral Leukoplakia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End of 8 treatments. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2012.