A Randomized Split-Face Clinical Trial of Photodynamic Therapy with Methyl Aminolevulinate versus Ingenol Mebutate Gel for the Treatment of Multiple Actinic Keratoses of the Face and Scalp

Abstract

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.

Gain with no pain? Pain management in dermatological photodynamic therapy

“…Evidence from numerous cutaneous diseases shows that PDT has the same efficacy as conventional therapies. [8][9][10][11][12][13][14][15][16][17][18] However, during the course of PDT, most patients experience sensations of burning and tingling pain that vary in intensity. In some cases, patients have to stop the treatment because of unbearable pain.…”

A seamless phase I/II dose-finding trial assessing ingenol disoxate (LEO 43204) for field treatment of actinic keratosis on the scalp

“…Photodynamic therapy (PDT) has comparable efficacy with ingenol mebutate 0·015% gel for the treatment of AK over 25 cm 2 . Trials comparing daylight PDT, aminolaevulinic acid PDT and methylaminolaevulinate PDT with ingenol mebutate have all demonstrated similar reductions in AK count, although ingenol mebutate may be more effective at clearing more advanced type II AK lesions than daylight PDT . Treatments such as PDT that are applied once or twice in the clinic inherently result in fewer adherence issues compared with topical AK therapies that are applied at home, sometimes over several weeks .…”

Adverse effects of topical photodynamic therapy: a consensus review and approach to management

“…Improved preference for PDT compared with cryotherapy was reported in a RCT, with a 5‐year follow‐up, comparing MAL‐PDT with cryotherapy for superficial BCC . MAL‐PDT compares favourably with ingenol mebutate when used for AKs on the face and scalp, with superior cosmetic outcomes and an overall patient preference for PDT, owing to higher pain scores and local skin reactions being more severe and persistent with ingenol mebutate . Similarly, when dPDT was compared with ingenol mebutate in 27 participants with AK in a within‐patient study, the former was better tolerated and preferred, and was associated with fewer adverse effects; efficacy was similar between the two modalities .…”

“…Thus, when MAL‐PDT was compared with ingenol mebutate for treatment of multiple AKs on the face and scalp in within‐patient, split‐face studies, pain scores and cosmetic outcome were higher with PDT, but local skin reactions were more severe and persistent with ingenol mebutate; overall, patients preferred PDT . When dPDT was compared with ingenol mebutate in 27 participants with AK in a within‐patient study, pain scores were higher for ingenol mebutate .…”