Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial

• Status: Not yet recruiting
• Trial end date: 2021-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Cancer, Brazil
• Treatments: Aminolevulinic Acid

Criteria

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)