Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial
Phase 2
- Conditions
- Actinic CheilitisLeukoplakiaErythroplakia
- Interventions
- Drug: Metil 5-aminolevulinate
- Registration Number
- NCT03990636
- Lead Sponsor
- Instituto Nacional de Cancer, Brazil
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo arm Metil 5-aminolevulinate Placebo (without metil 5-aminolevulinate) arm with photo activation. Metil 5-aminolevulinate arm Metil 5-aminolevulinate Metil 5-aminolevulinate arm with photo activation.
- Primary Outcome Measures
Name Time Method Histological cure 18 months Expected histological cure in 40% of cases
Complete clinical response 18 months Expected complete clinical response in 60% of cases
- Secondary Outcome Measures
Name Time Method IHC analysis 18 months Expression of immunohistochemical markers of cancer progression