Background: Photodynamic therapy with daylight (DL-PDT) is efficacious in treating actinic keratosis (AK), but the\nefficacy of field-directed, repetitive DL-PDT for the treatment and prophylaxis of AK in photodamaged facial skin\nhas not yet been investigated.\nMethods/design: In this multicenter, prospective, randomized, controlled, two-armed, observer-blinded trial,\npatients with a minimum of 5 mild-to-moderate AK lesions on photodamaged facial skin are randomly allocated to\ntwo treatment groups: DL-PDT with methyl aminolevulinate (MAL) and cryosurgery. In the DL-PDT group\n(experimental group), 5 treatments of the entire face are conducted over the course of 18 months. After\npreparation of the lesion and within 30 min after MAL application, patients expose themselves to daylight for 2 h.\nIn the control group, lesion-directed cryosurgery is conducted at the first visit and, in the case of uncleared or new\nAK lesions, also at visits 2 to 5. The efficacy of the treatment is evaluated at visits 2 to 6 by documenting all existing\nand new AK lesions in the face. Cosmetic results and improvement of photoaging parameters are evaluated by\nmeans of a modified Dover scale.\nPrimary outcome parameter is the cumulative number of AK lesions observed between visits 2 and 6.\nSecondary outcome parameters are complete clearance of AK, new AK lesions since the previous visit, cosmetic\nresults independently evaluated by both patient and physician, patient-reported pain (visual analogue scale), patient\nand physician satisfaction scores with cosmetic results, and patient-reported quality of life (Dermatology Life Quality\nIndex). Safety parameters are also documented (adverse events and serious adverse events).\nDiscussion: This clinical trial will assess the efficacy of repetitive DL-PDT in preventing AK and investigate possible\nrejuvenating effects of this treatment. (Trial registration: ClinicalTrials.gov Identifier: NCT02736760).
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