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

NCT02647151 Phase 4 UNKNOWN

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.

Details

Lead sponsor	Fundación Instituto Valenciano de Oncología
Phase	Phase 4
Status	UNKNOWN
Enrolment	50
Start date	2015-12
Completion	2016-03

Conditions

• Actinic Keratosis

Interventions

• METHYLAMINOLEVULINATE HYDROCHLORIDE
• AMINOLEVULINIC ACID HYDROCHLORIDE

Primary outcomes

• Comparison of MAL with the new BF -200 ALA photosensitizer in actinic keratosis. The Immediate and Delayed Local Reaction and Tolerance will be measured to compare MAL and ALA. — 1 month
  The main objective of this study is to compare the MAL with the new BF -200 ALA photosensitizer in terms of local reaction and tolerance for the treatment of actinic keratosis . First of all, the immediate local reaction to the lighting may include a greater or less erythema, inflammation and edema. It is scored on a scale of 0-10 where 0 is normal skin without local reaction and 10 is a maximum local reaction. The delayed local reaction is defined by the presence in different degrees of erythema, swelling, edema, pustules and scabs. They are also marked from 0 to 10 where 0 is normal skin without reaction and 10 for local maximum reaction. On the other hand, tolerance will be measured by the number, frequency and grade of reported adverse events in patients.

Countries

Spain