Clinical trial · Interventional
Treatment of Oral Premalignant Lesions With 5-ALA PDT
A Combined Phase I/II Single Site Study to Determine the Safety and Efficacy of Photodynamic Therapy (PDT) Utilizing 5-aminolevulinic Acid (5-ALA) and PDT in the Treatment of Premalignant Oral and/or Oropharynx 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)
Oral leukoplakia within the mouth is a visible white patch which can develop into cancer if not treated. There is no good treatment for these lesions, apart from surgery which is associated with significant side effects and physical deformation of the treated area. The investigators hypothesized that photodynamic therapy can be used safely and effectively to induce significant regression of oral leukoplakia.
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 |
|---|---|---|---|
| Erythroplakia | — | UNRESOLVED | — |
| Leukoplakia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Aminolevulinic Acid (Levulan KerastickTM) | Drug | 5-Aminolevulinic Acid | ALIAS |
| Fluorescence Diagnosis Imaging | Procedure | — | UNRESOLVED |
| PDL-585, ScleroPLUS laser | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1 light dose escalation
- description
- During Phase I, to determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion. The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD). Procedure: Fluorescence Diagnosis Imaging Interventions: Application of 5-ALA to lesion followed by activation with high power 585 nm pulsed dye laser (PDL-585, ScleroPLUS laser) at 6, 7 and 8 J/cm2.
- interventionNames
- Device: PDL-585, ScleroPLUS laser
- Drug: 5-Aminolevulinic Acid (Levulan KerastickTM)
- Procedure: Fluorescence Diagnosis Imaging
- type
- EXPERIMENTAL
- label
- Phase 2 - Treatment efficacy of PDT
- description
- Procedure: Fluorescence Diagnosis Imaging Interventions: Application of 5-ALA to lesion followed by activation with high power 585 nm pulsed dye laser (PDL-585, ScleroPLUS laser) at 8 J/cm2.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * At least one grossly visible premalignant lesion (i.e. leukoplakia or erythroplakia) in the oral cavity or oropharynx, with a confirmed diagnosis of leukoplakia with or without dysplasia,measuring ≥ 10 mm in diameter. * Informed of alternative treatment methods including watchful waiting, laser ablation, or surgical resection. * Eligible for long-term follow-up for at least one year and be able to tolerate biopsies. * Subject has signed an informed consent. * Subject is between the ages of 18 - 80 years of age. * Male or Female * Zubrod performance status of 0 or 1 at screening. See Appendix A Exclusion Criteria: * Known sensitivity to porphyrins or photoactive medications - See Appendix B * Invasive carcinoma of the lesion as demonstrated by biopsy. * Subjects with inherited or acquired blood clotting defects * Women who are breast feeding, have a positive (+) urine pregnancy test, or refuse to use 2 effective means of contraception during drug exposure and up to 48 hours after. * Subjects with porphyria * Life expectancy less than 12 months * Inability or unwillingness of subject to give written informed consent
References
Publications (1)
- RESULTShafirstein G, Friedman A, Siegel E, Moreno M, Baumler W, Fan CY, Morehead K, Vural E, Stack BC Jr, Suen JY. Using 5-aminolevulinic acid and pulsed dye laser for photodynamic treatment of oral leukoplakia. Arch Otolaryngol Head Neck Surg. 2011 Nov;137(11):1117-23. doi: 10.1001/archoto.2011.178. PMID 22106236