LeukoplakiaPhase 3PDTNCT01497951
Photodynamic Therapy for Oral Precursor Lesions
A Phase 3 study testing Aminolaevulinic acid in people with Leukoplakia and Lichen, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical removal is not always possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukoplakia, Lichen
- What is being tested?
- Aminolaevulinic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteAustria
- Study dates
- May 2011to Jan 2017
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Existing Leukoplakia simplex SIN III (diagnostics by Biopsie)
- Leukoplakia verrucosa without indications of malignant changes (diagnostics by Biopsie)
- Oral Lichen planus SIN III (diagnostics by Biopsie)
- Good mouth hygiene status (tartar, surface)
- Correct seat of the prosthesis and/or the denture
- Located erosions in the oral cavity
- Minimum age:18 years
- Women at the age capable of child-bearing with an appropriate contraception
Who cannot join
- Malignant changes of the mucous membrane, heavy Dysplasie SIN III, Carcinoma in situ - heavy vitamin deficiency
- Pregnancy
- less than 18
- Satisfying women
- No tobacco abuse
- satisfying therapy with local immunmodulators in lichen ruber
- surgical therapy of leukoplakia indicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.
Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical removal is not always possible. The photodynamic therapy uses a special substance, which is absorbed in cells, and thereafter activated by a defined light. The aim of this study is to compare the photodynamic therapy in potentially malignant lesions to a placebo. The investigators assume a significant better result in photodynamic therapy then treatment with a placebo.
- Conditions
- Leukoplakia, Lichen
- Being tested
- Aminolaevulinic acid, Methylcellulose Placebo
- Medical subject headings
- Leukoplakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolaevulinic acidOther
Photodynamic therapy
Methylcellulose PlaceboOther
Methylcellulose
| Study group | Role | What they receive |
|---|---|---|
| Aminolaevulinic acid | Experimental | Not described Receives: Other: Aminolaevulinic acid |
| Placebo | Placebo comparator | Not described Receives: Other: Methylcellulose Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper.
Measured: each treatment average once a week, recall after 4 weeks
Secondary outcomes (1)
pain due to treatment, assessed by visual analogue scale (VAS)
Measured: each treatment, average once a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukoplakiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dvorak Gabriella, Medical University of Vienna
- Investigators
- Gabriella Dvorak, PD, DMD, MD, Study director, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497951
- Sponsor's protocol ID
- 2010_MuSH
- Acronym
- PDT
- Status last verified
- May 2017
- First submitted
- 9 Dec 2011
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.
- ClinicalTrials.gov ID
- NCT01497951
- Acronym / sponsor ID
- PDT / 2010_MuSH
- Conditions
- Leukoplakia, Lichen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 23 Dec 2011 (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.
Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical removal is not always possible. The photodynamic therapy uses a special substance, which is absorbed in cells, and thereafter activated by a defined light. The aim of this study is to compare the photodynamic therapy in potentially malignant lesions to a placebo. The investigators assume a significant better result in photodynamic therapy then treatment with a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aminolaevulinic acid | Experimental | Other: Aminolaevulinic acid |
| Placebo | Placebo comparator | Other: Methylcellulose Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Existing Leukoplakia simplex SIN III (diagnostics by Biopsie)
- Leukoplakia verrucosa without indications of malignant changes (diagnostics by Biopsie)
- Oral Lichen planus SIN III (diagnostics by Biopsie)
- Good mouth hygiene status (tartar, surface)
- Correct seat of the prosthesis and/or the denture
Key exclusion criteria (7 listed)
- Malignant changes of the mucous membrane, heavy Dysplasie SIN III, Carcinoma in situ - heavy vitamin deficiency
- Pregnancy
- less than 18
- Satisfying women
- No tobacco abuse
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 |
|---|---|---|
| Aminolaevulinic acidPhotodynamic therapy | Other | Aminolaevulinic acid |
| Methylcellulose PlaceboMethylcellulose | Other | Placebo |
Primary outcome
Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper.
Time frame: each treatment average once a week, recall after 4 weeks
1 secondary outcome
pain due to treatment, assessed by visual analogue scale (VAS)
Time frame: each treatment, average once a week
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 17 May 2017.
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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.
Gabriella Dvorak, PD, DMD, MD study director
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aminolaevulinic acid in people with Leukoplakia and Lichen, run by Medical University of Vienna at 1 site in Austria.
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 8 inclusion and 7 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 17 May 2017. 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 Austria. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper. (time frame: each treatment average once a week, recall after 4 weeks). 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 17 May 2017; AzTrials last refreshed its copy on 26 Oct 2026.