Background: Photodynamic therapy with methyl aminolevulinate (MAL-PDT) and ingenol mebutate gel (IMB) are approved therapeutic options for multiple actinic keratoses (AKs). Objective: The aim of this intraindividual, split-face, randomized clinical trial was to compare treatment outcomes of MAL-PDT and IMB. Methods: Two symmetrical contralateral areas with a similar number of AKs were selected and randomly assigned to 3 days of an IMB treatment cycle or a single session of MAL-PDT. The next day, the local skin reaction (LSR) score was registered. The patients scored pain and time to healing of the treatment area. Results: After 90 days, the complete remission rate of lesions, the number of patients with complete remission of all lesions, cosmetic outcome, and patient preference were assessed. Conclusion: According to our results, IMB and MAL-PDT had a similar efficacy, but the cosmetic outcome was superior with MAL-PDT. Pain was higher with PDT, but LSR was more severe and time to healing was longer with IMB. Patients preferred MAL-PDT.

Stockfleth E, Ferrandiz C, Grob JJ, Leigh I, Pehamberger H, Kerl H; European Skin Academy: Development of a treatment algorithm for actinic keratoses: a European Consensus. Eur J Dermatol 2008;18:651-659.
De Berker D, McGregor JM, Hughes BR; British Association of Dermatologists Therapy Guidelines and Audit Subcommittee: Guidelines for the management of actinic keratoses. Br J Dermatol 2007;156:222-230.
Werner RN, Stockfleth E, Connolly SM, Correia O, Erdmann R, Foley P, Gupta AK, Jacobs A, Kerl H, Lim HW, Martin G, Paquet M, Pariser DM, Rosumeck S, Röwert-Huber HJ, Sahota A, Sangueza OP, Shumack S, Sporbeck B, Swanson NA, Torezan L, Nast A: Evidence- and consensus-based (S3) Guidelines for the Treatment of Actinic Keratosis - International League of Dermatological Societies in cooperation with the European Dermatology Forum - short version. J Eur Acad Dermatol Venereol 2015;29:2069-2079.
Vegter S, Tolley K: A network meta-analysis of the relative efficacy of treatments for actinic keratosis of the face or scalp in Europe. PLoS One 2014;9:96829.
Olsen EA, Abernethy ML, Kulp-Shorten C, Callen JP, Glazer SD, Huntley A, McCray M, Monroe AB, Tschen E, Wolf JE Jr: A double-blind, vehicle-controlled study evaluating masoprocol cream in the treatment of actinic keratoses on the head and neck. J Am Acad Dermatol 1991;24:738-743.
Galderma: Metvix 160 mg/g Cream: Summary of Product Characteristics. (accessed November 17, 2015).
Tzogani K, Nagercoil N, Hemmings RJ, Samir B, Gardette J, Demolis P, Salmonson T, Pignatti F: The European Medicines Agency approval of ingenol mebutate (Picato) for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults: summary of the scientific assessment of the Committee for Medicinal Products for Human Use (CHMP). Eur J Dermatol 2014 ;24:457-463.
Babilas P, Kohl E, Maisch T, Bäcker H, Gross B, Branzan AL, Bäumler W, Landthaler M, Karrer S, Szeimies RM: In vitro and in vivo comparison of two different light sources for topical photodynamic therapy. Br J Dermatol 2006;154:712-718.
Zane C, Capezzera R, Sala R, Venturini M, Calzavara-Pinton P: Clinical and echographic analysis of photodynamic therapy using methyl aminolevulinate as sensitizer in the treatment of photodamaged facial skin. Lasers Surg Med 2007;39:203-209.
Morton CA, Szeimies RM, Sidoroff A, Braathen LR: European guidelines for topical photodynamic therapy. Part 2. Emerging indications - field cancerization, photorejuvenation and inflammatory/infective dermatoses. J Eur Acad Dermatol Venereol 2013;27:672-679.
Food and Drug Administration: Picato (ingenol mebutate) Gel: Drug Safety Communication - FDA Warns of Severe Adverse Events, Requires Label Changes.
Zane C, Facchinetti E, Rossi MT, Specchia C, Calzavara-Pinton PG: A randomized clinical trial of photodynamic therapy with methyl aminolaevulinate vs. diclofenac 3% plus hyaluronic acid gel for the treatment of multiple actinic keratoses of the face and scalp. Br J Dermatol 2014;170:1143-1150.
Szeimies RM, Karrer S, Radakovic-Fijan S, Tanew A, Calzavara-Pinton PG, Zane C, Sidoroff A, Hempel M, Ulrich J, Proebstle T, Meffert H, Mulder M, Salomon D, Dittmar HC, Bauer JW, Kernland K, Braathen L: Photodynamic therapy using topical methyl 5-aminolevulinate compared with cryotherapy for actinic keratosis: a prospective, randomized study. J Am Acad Dermatol 2002;47:258-262.
Freeman M, Vinciullo C, Francis D, Spelman L, Nguyen R, Fergin P, Thai KE, Murrell D, Weightman W, Anderson C, Reid C, Watson A, Foley P: A comparison of photodynamic therapy using topical methyl aminolevulinate (Metvix) with single cycle cryotherapy in patients with actinic keratosis: a prospective, randomized study. J Dermatolog Treat 2003;14:99-106.
Morton C, Campbell S, Gupta G, Keohane S, Lear J, Zaki I, Walton S, Kerrouche N, Thomas G, Soto P; AKtion Investigators: Intraindividual, right-left comparison of topical methyl aminolaevulinate-photodynamic therapy and cryotherapy in subjects with actinic keratoses: a multicentre, randomized controlled study. Br J Dermatol 2006;155:1029-1036.
Kaufmann R, Spelman L, Weightman W, Reifenberger J, Szeimies RM, Verhaeghe E, Kerrouche N, Sorba V, Villemagne H, Rhodes LE: Multicentre intraindividual randomized trial of topical methyl aminolaevulinate-photodynamic therapy vs. cryotherapy for multiple actinic keratoses on the extremities. Br J Dermatol 2008;158:994-999.
Dréno B, Amici JM, Basset-Seguin N, Cribier B, Claudel JP, Richard MA; AKTeam™: Management of actinic keratosis: a practical report and treatment algorithm from AKTeam expert clinicians. J Eur Acad Dermatol Venereol 2014;28:1141-1149.
Sotiriou E, Apalla Z, Vrani F, Lallas A, Chovarda E, Ioannides D: Photodynamic therapy vs. imiquimod 5% cream as skin cancer preventive strategies in patients with field changes: a randomized intraindividual comparison study. J Eur Acad Dermatol Venereol 2015;29:325-329.
Samorano LP, Torezan LA, Sanches JA: Evaluation of the tolerability and safety of a 0.015% ingenol mebutate gel compared to 5% 5-fluorouracil cream for the treatment of facial actinic keratosis: a prospective randomized trial. J Eur Acad Dermatol Venereol 2015;29:1822-1827.
Esmann S, Jemec GB: Patients' perceptions of topical treatments of actinic keratosis. J Dermatolog Treat 2014;25:375-379.
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.