Clinical trial · Interventional
Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial
Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - A Phase 2 Randomized Double-blind Placebo Controlled Clinical Trial
- 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)
Brazil is a tropical country, with high incidence of ultraviolet radiation throughout the year. Many Europeans migrated to Brazil escaping either war or economic crisis to live in the country searching for opportunities. Low phototype combined with high incidence of UV light is a combination that not only affect the skin but also the lips. The current study was designed to use photodynamic therapy with metil 5-aminolevulinate for actinic cheilitis in a phase 2 clinical trial.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Cheilitis | — | UNRESOLVED | — |
| Erythroplakia | — | UNRESOLVED | — |
| Leukoplakia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metil 5-aminolevulinate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metil 5-aminolevulinate arm
- description
- Metil 5-aminolevulinate arm with photo activation.
- interventionNames
- Drug: Metil 5-aminolevulinate
- type
- PLACEBO_COMPARATOR
- label
- Placebo arm
- description
- Placebo (without metil 5-aminolevulinate) arm with photo activation.
- interventionNames
- Drug: Metil 5-aminolevulinate
Primary outcomes (2)
- measure
- Complete clinical response
- timeFrame
- 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical diagnosis with histopathological confirmation of actinic cheilitis * Patients will be requested to respect the timeframe of clinical consultations * No treatment for actinic cheilitis in the last 3 months Exclusion Criteria: * Histopathological diagnosis of squamous cell carcinoma (SCC) * Patient presenting any type of immunosupression * Recurrent crust of the lip vermilion (high risk of SCC)
References
Publications (0)
Data not yet available