Clinical trial · Interventional
Photodynamic Therapy for Oral Precursor Lesions
A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukoplakia | — | UNRESOLVED | — |
| Lichen | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aminolaevulinic acid | Other | — | UNRESOLVED |
| Methylcellulose Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aminolaevulinic acid
- interventionNames
- Other: Aminolaevulinic acid
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Other: Methylcellulose Placebo
Primary outcomes (1)
- measure
- Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper.
- timeFrame
- each treatment average once a week, recall after 4 weeks
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available