A Phase 2 interventional study of Metil 5-aminolevulinate in Actinic Cheilitis, Leukoplakia and Erythroplakia, sponsored by Instituto Nacional de Cancer, Brazil. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-19.
Sponsored by Instituto Nacional de Cancer, Brazil · Phase 2, Interventional, and Treatment
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.
21 studies on the registry are indexed under Leukoplakia; 7 are open to participants now.
This study's planned enrollment of 40 is above the median of 35 across 12 interventional studies indexed under Leukoplakia.
Browse Leukoplakia studies →Instituto Nacional de Cancer, Brazil is the lead sponsor of 41 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Metil 5-aminolevulinate arm with photo activation.
Drug: Metil 5-aminolevulinate
Placebo (without metil 5-aminolevulinate) arm with photo activation.
Drug: Metil 5-aminolevulinate
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
No study locations are listed for this record.
Plan to share: No — The Informed Consent Form (ICF) will be read and explained to each patient informing about all the risks and potential benefits. Clinical Study Report (CSR) is going to be registered for all patients, although data will not be shared.
No publications or documents are linked to this record.
Start is estimated for Oct 2019; primary completion for May 2020, 6 months later.
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This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Cancer, Brazil