drugset / Trial / NCT02647151

Efficacy and Safety of Treatment of Actinic Keratoses With Photodynamic Therapy Between MAL Cream and ALA Gel

NCT02647151

Phase 4 Unknown 50 enrolled Fundación Instituto Valenciano de Oncología
RandomizedCrossoverSingle-blindTreatment

Summary

Photodynamic therapy technique (PDT) is a conventional technique which is performed applying the product under occlusion lesions, let it incubate for 3 hours and then exposed skin to a light source, usually red. The conclusions of efficacy, tolerance and satisfaction that today are known about PDT with MAL, but not with ALA, which is a new photosensitizer indicated for Actinic Keratoses. The pharmaceutical form of ALA is a gel, which gives a hypothetical better penetration and consequently it is more effectively.

Timeline

Start
2015-12
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Aminolevulinic Acid Diagnostic / imaging agent 78 unknown Topical
Subject methyl aminolevulinate Small molecule 160 unknown Topical

Indications