Daylight photodynamic therapy with methyl aminolevulinate cream as a convenient, similarly effective, nearly painless alternative to conventional photodynamic therapy in actinic keratosis treatment: a randomized controlled trial
- 20 October 2014
- journal article
- research article
- Published by Wiley in British Journal of Dermatology
- Vol. 171 (5), 1164-1171
- https://doi.org/10.1111/bjd.13138
Abstract
Daylight photodynamic therapy (DL-PDT) of actinic keratosis (AK) has shown preliminary efficacy and safety results comparable to conventional photodynamic therapy (c-PDT), using methyl aminolevulinate (MAL) cream. To demonstrate the efficacy and safety of DL-PDT vs. c-PDT in treating mild facial/scalp AK. This 24-week randomized, controlled, investigator-blinded, multicentre, intra-individual efficacy (non-inferiority) and safety (superiority regarding pain) study enrolled 100 subjects. AKs on the face/scalp were treated once, with DL-PDT on one side and c-PDT on the contralateral side. Primary end points for DL-PDT at week 12 were efficacy [non-inferiority regarding complete lesion response (mild AK)] and safety (superiority regarding subject's assessment of pain). Lesions with complete response 12 weeks after one treatment session were followed until week 24. The safety evaluation included incidence of adverse events. Subject satisfaction was classified using a questionnaire. At week 12, the complete lesion response rate with DL-PDT was non-inferior to c-PDT (89·2% vs. 92·8%, respectively; 95% confidence interval -6·8 to -0·3), confirmed by intention-to-treat analysis. Additionally, regardless of the treatment used, 96% of mild lesions were maintained in complete response 24 weeks after the PDT session. For DL-PDT, subject-reported pain was significantly lower (0·8 vs. 5·7, respectively; P < 0·001), with better tolerability and significantly higher subject satisfaction regarding convenience and outcome. Daylight-mediated PDT was not inferior in efficacy to Metvix c-PDT (mild AK response rate), better tolerated, nearly painless and more convenient for patients.Keywords
Funding Information
- Galderma R&D
This publication has 13 references indexed in Scilit:
- European guidelines for topical photodynamic therapy part 1: treatment delivery and current indications – actinic keratoses, Bowen’s disease, basal cell carcinomaJournal of the European Academy of Dermatology and Venereology, 2012
- Daylight Photodynamic Therapy in Private Practice in Switzerland: Gain Without PainActa Dermato Venereologica, 2012
- A randomized, multicentre study of directed daylight exposure times of 1½ vs. 2½ h in daylight-mediated photodynamic therapy with methyl aminolaevulinate in patients with multiple thin actinic keratoses of the face and scalpBritish Journal of Dermatology, 2011
- Photodynamic therapy of actinic keratoses with 8% and 16% methyl aminolaevulinate and home-based daylight exposure: a double-blinded randomized clinical trialBritish Journal of Dermatology, 2009
- Continuous activation of PpIX by daylight is as effective as and less painful than conventional photodynamic therapy for actinic keratoses; a randomized, controlled, single-blinded studyBritish Journal of Dermatology, 2008
- Guidelines for the management of actinic keratosesBritish Journal of Dermatology, 2007
- Epidemiology of solar keratosesBritish Journal of Dermatology, 2006
- Prevalence of Actinic Keratoses and Associated Factors in a Representative Sample of the Italian Adult PopulationArchives of Dermatology, 2006
- Porphyrin Formation in Actinic Keratosis and Basal Cell Carcinoma after Topical Application of Methyl 5-AminolevulinateJournal of Investigative Dermatology, 2006
- New trends in photobiologyJournal of Photochemistry and Photobiology B: Biology, 1992