Transepidermal Application of Metilaminolevulinate in Daylight Photodynamic Therapy in the Treatment of Photodamaged Skin

This is a randomized controlled, parallels-groups, four-arm trial with 1:1 allocation ratio study on the clinical, histological and immunohistochemical changes induced by Daylight-Photodynamic Therapy (DL-PDT) in 40 patients presenting face-photodamaged skin with actinic keratosis, attended at the Dermatology outpatient clinic of Hospital Antônio Pedro (HUAP) of Universidade Federal Fluminense - UFF, who meet the inclusion criteria and agree to sign the informed consent form (TCLE) for participation in clinical research. There will be four treatment groups with different protocols. These protocols were chosen by hand draw using two boxes containing folded papers. One with the 4 numbers of the groups (1, 2, 3, 4), and another with 4 papers with the names of the protocols. At each draw, one paper from each box was withdrawn, and the combined results from the two boxes defined the treatments of each group. Group I was randomly selected to be DL-PDT alone (standard procedure - group control); Group II was randomly selected to be DL-PDT with TED (microneedles); Group III was randomly selected to be DL-PDT with TED (CO2 laser) and Group IV was was randomly selected to be DL-PDT with TED (microdermabrasion with crystal peeling). Two treatment sessions will be performed with a 4-week interval, regardless of the protocol chosen per group. Patients will be numbered according to the registration for participation in the study. These numbers will be distributed in 4 groups randomly through the computer, using an Apple application called Random (random number generator: seller Mireia Lluch Ortoloa, category utilities, version 1). Each DL-PDT session will consist of: superficial skin curettage all face with a dermatological curette; application of pure chemical sunscreen for 15 minutes; application of methyl-aminolevulinate (Metvix®, GALDERMA), approved by ANVISA under Registration No. 1291600650016, for 30 minutes without occlusion, before exposure to daylight for 2 hours. Regarding the association of techniques, these will be varied according to the group. For clinical evaluation, patient data will be recorded on the evaluation form, and photographs with the same position and lighting patterns will be performed before and after predetermined periods. For histological and immunohistochemical evaluations, skin biopsies will be performed before and after 3 months of the last treatment session.