Actinic Keratosis Clinical Trial
Official title:
Comparative Intraindividual Study, About the Efficacy and Safety of Treatment of Actinic Keratoses With Photodynamic Therapy Between Acid Methyl Aminolevulinate Cream and Aminolevulinic Gel
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.
Intraindividual comparative study, to evaluate efficacy and safety of the treatment of
actinic keratosis with photodynamic therapy between methyl aminolevulinate cream (MAL) and
aminolevulinic acid nanosoma gel (ALA).
MAL cream: is an antineoplastic agent used as a photosensitizer for photodynamic therapy
(PDT). The mode of action of methyl aminolevulinate in PDT was shown in the pharmacodynamic
(PD) studies. In the target cells,methyl aminolevulinate was converted to photoactive
porphyrins, including protoporphyrinIX (PpIX), which are the active photosensitizers. Upon
light activation, the photosensitizers give rise to the production of cytotoxic singlet
oxygen species which destroy the target cells.
ALA gel: Following topical application of 5-aminolaevulinic acid, the substance is
metabolized to protoporphyrin IX, a photoactive compound which accumulates intracellularly
in the treated actinic keratosis lesions. Protoporphyrin IX is activated by illumination
with red light of a suitable wavelength and energy. In the presence of oxygen, reactive
oxygen species are formed. The latter causes damage of cellular components and eventually
destroys the target cells.
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 QA. The pharmaceutical
form of ALA is a gel, which gives a hypothetical better penetration and consequently it is
more effectively.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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