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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Scrubbing lip vermillion and applying the medication or placebo that is activated (or not, in case of placebo) with red light.
Complete clinical response
Expected complete clinical response in 60% of cases
Time frame: 18 months
Histological cure
Expected histological cure in 40% of cases
Time frame: 18 months
IHC analysis
Expression of immunohistochemical markers of cancer progression
Time frame: 18 months
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