NCT02647151

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

Comparative Intraindividual Study, About the Efficacy and Safety of Treatment of Actinic Keratoses With Photodynamic Therapy Between Acid Methyl Aminolevulinate Cream and Aminolevulinic Gel

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fundación Instituto Valenciano de Oncología · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	METHYLAMINOLEVULINATE HYDROCHLORIDE	This is an intrapatient randomized clinical trial. All patients participating in the trial will receive both, experimental and control treatment, randomization will be used to determine side (right or left for treatment). Three visits will be scheduled. In the first visit epidemiological data will be collected , Actinic Keratoses are counted and drawn in a transparent template and also a photograph of each side. In that first visit treatment the PDT will be also performed, the degree of fluorescence, the pain and the degree of immediate local reaction will be measured. skin after PDT. In the second visit, to be held at 2 or 3 days, the delayed local reaction degree will be assessed. And in the third visit, held a month of PDT the clinical response and patient satisfaction will be assessed.
DRUG	AMINOLEVULINIC ACID HYDROCHLORIDE	This is an intrapatient randomized clinical trial. All patients participating in the trial will receive both, experimental and control treatment, randomization will be used to determine side (right or left for treatment). Three visits will be scheduled. In the first visit epidemiological data will be collected , Actinic Keratoses are counted and drawn in a transparent template and also a photograph of each side. In that first visit treatment the PDT will be also performed, the degree of fluorescence, the pain and the degree of immediate local reaction will be measured. skin after PDT. In the second visit, to be held at 2 or 3 days, the delayed local reaction degree will be assessed. And in the third visit, held a month of PDT the clinical response and patient satisfaction will be assessed.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2016-01-06
• Last updated: 2016-01-06

Locations

1 site across 1 country: Spain