High Patient Satisfaction with Daylight-Activated Methyl Aminolevulinate Cream in the Treatment of Multiple Actinic Keratoses: Results of an Observational Study in Australia

Jo-Ann See, Kurt Gebauer, Jason K Wu, Shobhan Manoharan, Nabil Kerrouche, John Sullivan, Jo-Ann See, Kurt Gebauer, Jason K Wu, Shobhan Manoharan, Nabil Kerrouche, John Sullivan

Abstract

Introduction: Actinic keratoses (AK) are treated to reduce the risk of progression to squamous cell carcinoma and for symptomatic and cosmetic benefits. The objective of this observational study was to generate real-life data on the use of daylight photodynamic therapy with methyl aminolevulinate cream (MAL DL-PDT) in treating mild to moderate facial/scalp AK.

Methods: A multicenter, prospective, observational study was conducted in Australia in patients receiving a single treatment of MAL DL-PDT for mild to moderate AK. Efficacy was assessed 3 months after treatment by investigator-assessed improvement and patient- and physician-completed satisfaction questionnaires. Adverse events were recorded throughout the study.

Results: Overall, 81 patients were enrolled of mean age 62.7 years, mostly men (76.5%) with skin phototype I (64.2%) or II (35.8%) and a long history of AK (mean duration 16.8 years). Most had multiple lesions (82.7% had >10 lesions) of predominantly grade I (75.3%). At 3 months after treatment, almost half the patients (46.8%) required no further treatment. The proportions of patients and physicians satisfied to very satisfied with the MAL DL-PDT treatment were 79.7% and 83.3%, respectively. After receiving the treatment, 74.1% of patients indicated via the questionnaire that they were not bothered at all by the pain. Related AEs were reported in 48.1% of patients, mainly mild erythema (44.4%).

Conclusions: In clinical practice in Australia, the use of MAL DL-PDT in treating multiple mild to moderate non-hyperkeratotic AK of the face and/or scalp results in high levels of patient and physician satisfaction reflecting the good efficacy and tolerability of this almost painless, convenient procedure.

Trial registration: ClinicalTrials.gov identifier, NCT02674048.

Funding: Galderma R&D.

Keywords: Actinic keratosis; Australia; Daylight-activated photodynamic therapy; Methyl aminolevulinate cream; Observational study.

Figures

Fig. 1
Fig. 1
Overall satisfaction with daylight-activated methyl aminolevulinate treatment according to patient and physician questionnaires at end of study
Fig. 2
Fig. 2
Patient satisfaction with the treatment effectiveness and the appearance of their treated skin at end of study
Fig. 3
Fig. 3
Patient responses when asked a How does daylight-activated methyl aminolevulinate compare with your last treatment for actinic keratosis? b Would you use daylight-activated methyl aminolevulinate again? and c How bothered were you by any pain?

References

    1. Frost CA, Green AC. Epidemiology of solar keratoses. Br J Dermatol. 1994;131(4):455–464. doi: 10.1111/j.1365-2133.1994.tb08544.x.
    1. Frost C, Williams G, Green A. High incidence and regression rates of solar keratoses in a Queensland community. J Invest Dermatol. 2000;115(2):273–277. doi: 10.1046/j.1523-1747.2000.00048.x.
    1. Thompson SC, Jolley D, Marks R. Reduction of solar keratoses by regular sunscreen use. N Engl J Med. 1993;329(16):1147–1151. doi: 10.1056/NEJM199310143291602.
    1. Czarnecki D, Meehan CJ, Bruce F, Culjak G. The majority of cutaneous squamous cell carcinomas arise in actinic keratoses. J Cutan Med Surg. 2002;6(3):207–209. doi: 10.1177/120347540200600301.
    1. Gupta AK, Paquet M, Villanueva E, Brintnell W. Interventions for actinic keratoses. Cochrane Database Syst Rev. 2012;12:CD004415.
    1. Calzavara-Pinton P, Hædersdal M, Barber K, et al. Structured expert consensus on actinic keratosis: treatment algorithm focusing on daylight PDT. J Cutan Med Surg. 2017;21(1S):3S–16S. doi: 10.1177/1203475417702994.
    1. Rubel DM, Spelman L, Murrell DF, et al. 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. Br J Dermatol. 2014;171:1164–1171. doi: 10.1111/bjd.13138.
    1. Lacour JP, Ulrich C, Gilaberte Y, et al. Daylight photodynamic therapy with methyl aminolevulinate cream is effective and nearly painless in treating actinic keratoses: a randomised, investigator-blinded, controlled, phase III study throughout Europe. J Eur Acad Dermatol Venereol. 2015;29(12):2342–2348. doi: 10.1111/jdv.13228.
    1. Spelman L, Rubel D, Murrell DF, et al. Treatment of face and scalp solar (actinic) keratosis with daylight-mediated photodynamic therapy is possible throughout the year in Australia: evidence from a clinical and meteorological study. Australas J Dermatol. 2016;57(1):24–28. doi: 10.1111/ajd.12295.
    1. See JA, Shumack S, Murrell DF, et al. Consensus recommendations on the use of daylight photodynamic therapy with methyl aminolevulinate cream for actinic keratoses in Australia. Australas J Dermatol. 2016;57(3):167–174. doi: 10.1111/ajd.12354.
    1. Philipp-Dormston WG, Sanclemente G, Torezan L, et al. Daylight photodynamic therapy with MAL cream for large-scale photodamaged skin based on the concept of ‘actinic field damage’: recommendations of an international expert group. J Eur Acad Dermatol Venereol. 2016;30(1):8–15. doi: 10.1111/jdv.13327.
    1. Werner RN, Stockfleth E, Connolly SM, et al. 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(11):2069–2079. doi: 10.1111/jdv.13180.
    1. Gholam P, Fink C, Bosselmann I, Enk AH. Retrospective analysis evaluating the effect of a keratolytic and physical pretreatment with salicylic acid, urea and curettage on the efficacy and safety of photodynamic therapy of actinic keratosis with methylaminolaevulinate. J Eur Acad Dermatol Venereol. 2016;30(4):619–623. doi: 10.1111/jdv.13449.
    1. Matthews YJ, Damian DL. Topical photodynamic therapy is immunosuppressive in humans. Br J Dermatol. 2010;162(3):637–641. doi: 10.1111/j.1365-2133.2009.09562.x.
    1. Frost GA, Halliday GM, Damian DL. Photodynamic therapy-induced immunosuppression in humans is prevented by reducing the rate of light delivery. J Invest Dermatol. 2011;131(4):962–968. doi: 10.1038/jid.2010.429.
    1. Giomi B, Pagnini F, Cappuccini A, Bianchi B, Tiradritti L, Zuccati G. Immunological activity of photodynamic therapy for genital warts. Br J Dermatol. 2011;164(2):448–451. doi: 10.1111/j.1365-2133.2010.10089.x.
    1. Castano AP, Mroz P, Hamblin MR. Photodynamic therapy and anti-tumour immunity. Nat. Rev. Cancer. 2006;6(7):535–545. doi: 10.1038/nrc1894.
    1. Mroz P, Szokalska A, Wu MX, Hamblin MR. Photodynamic therapy of tumors can lead to development of systemic antigen-specific immune response. PLoS ONE. 2010;5(12):e15194. doi: 10.1371/journal.pone.0015194.
    1. Kabingu E, Vaughan L, Owczarczak B, Ramsey KD, Gollnick SO. CD8+ T cell-mediated control of distant tumours following local photodynamic therapy is independent of CD4+ T cells and dependent on natural killer cells. Br J Cancer. 2007;96(12):1839–1848. doi: 10.1038/sj.bjc.6603792.

Source: PubMed

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