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Daylight Photodynamic Therapy Versus 5-Fluorouracil for the Treatment of Actinic Keratosis: a Case Series

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Daylight Photodynamic Therapy Versus 5-Fluorouracil for the Treatment of Actinic Keratosis: a Case Series Dermatol Ther (Heidelb) (2018) 8:137–141 https://doi.org/10.1007/s13555-017-0219-9 BRIEF REPORT Daylight Photodynamic Therapy Versus 5-Fluorouracil for the Treatment of Actinic Keratosis: A Case Series Gaston Nestor Galimberti Received: November 23, 2017 / Published online: January 10, 2018 Ó The Author(s) 2018. This article is an open access publication ABSTRACT DL-PDT than with 5-FU, and they resolved spontaneously in 5–7 and 27–30 days, respec- Introduction: The incidence of actinic keratosis tively. Subjects preferred DL-PDT because of the (AK) continues to increase worldwide. Currently lower incidence of AEs and rapid recovery available options for the treatment of AK compared with 5-FU. include topical 5-fluorouracil (5-FU) and day- Conclusion: DL-PDT is a convenient alternative light-mediated photodynamic therapy (DL- to 5-FU with good efficacy and a favorable safety PDT). This split-face pilot study compared DL- profile, allowing patients to effectively treat PDT using 16% methyl aminolevulinate (MAL) their AK without compromising their social life. cream versus 5-FU cream in patients with AK on Funding: Galderma. the face/scalp. Methods: Five male subjects (mean age Keywords: 5-Fluorouracil; Cancerization field; 70 years) with grade I–III AK on the face/scalp Daylight-mediated photodynamic therapy; were enrolled. Subjects received a single session Methyl aminolevulinate; Photodamage of DL-PDT with 16% MAL on one side and topical 5% 5-FU for 21 days on the other side. Evaluations of efficacy, safety, and subject sat- INTRODUCTION isfaction were conducted 48 h, 7 days, 14 days, 1 month, and 3 months after treatment. Actinic keratoses (AKs) are precancerous lesions Results: At 3 months, the lesion complete with an increasing incidence worldwide [1]. response rate was 80% and 93% for DL-PDT and Currently, there are various options available 5-FU, respectively. Lesion partial response was for the treatment of AK including topical and 20% and 7%, respectively. Fewer treatment-re- photodynamic therapy (PDT). Topical 5-fluo- lated adverse events (AEs) were reported with rouracil (5-FU) has been shown to be efficacious in treating AK [2]. Moreover, daylight-mediated PDT (DL-PDT) has offered a simpler, safer, and Enhanced content To view enhanced content for this article go to http://www.medengine.com/Redeem/ more convenient—as well as equally effica- B90DF06076A5F2FA. cious—option compared with conventional PDT [3–6]. G. N. Galimberti (&) The objective of this comparative pilot study Department of Dermatology, School of Medicine, was to evaluate the efficacy, safety, and patient Hospital Italiano de Buenos Aires, Buenos Aires, Argentina satisfaction of DL-PDT using 16% methyl e-mail: [email protected] aminolevulinate (MAL) cream versus topical 138 Dermatol Ther (Heidelb) (2018) 8:137–141 treatment using 5-FU cream in patients with AK Assessments included lesion (AK) counts, on the face and scalp. safety, subject satisfaction, and subject photog- raphy using a conventional camera. Evaluations were conducted 48 h, 7 days, and 14 days after METHODS treatment, as well as at 1- and 3-month follow- ups. The study included five subjects with grade I–III All subjects provided written informed con- AK, according to Olsen’s classification [7], on sent prior to their participation in the study. the face or scalp. The subjects were randomly recruited through the daily consultation of the cutaneous oncology agenda of the Department RESULTS of Dermatology at the Hospital Italiano de Buenos Aires in November 2016. The lesion complete response rate (clinical All subjects were male with a mean age of remission of lesions) 3 months after treatment 70 years (range 60–80 years). They presented with DL-PDT and 5-FU was 80% and 93%, with phototype I (3 subjects; 60%) and II (2 respectively. The lesion partial response (de- subjects; 40%). All subjects provided written crease in lesion severity assessed visually) was informed consent prior to participation in the 20% and 7%, respectively. DL-PDT with 16% study. MAL cream is approved for a single session, with The study followed a split-face design. The the possibility of a second session after region of interest on the face or scalp was divi- 3 months, if deemed necessary by the treating ded into two areas, each receiving a single ses- physician [1, 8]. The analysis of the present sion of DL-PDT or topical 5% 5-FU treatment. comparison study is based exclusively on data Prior to DL-PDT, the treatment area was from a single session of DL-PDT. Considering cleansed with 0.9% saline solution. Organic SPF the close efficacy observed between the two 30 sunscreen was applied to the treatment area treatments in this study, it is likely that a sec- as well as all areas of the face/scalp exposed to ond session of DL-PDT would yield similar effi- sunlight. Subsequently, surface curettage was cacy to 5-FU. performed to remove lesion crusts and scales. A Safety assessment revealed a lower incidence thin layer of 16% MAL cream was applied (1 g of adverse events (AEs) with DL-PDT (erythema, per area), and the subjects left the clinic with scales, and scabs) compared with 5-FU (ery- instructions to initiate direct exposure to sun- thema, crusts, pustules, and pruritus). More- light within 30 min of MAL cream application. over, the duration of AEs was shorter with DL- Moreover, they were instructed to allow 2 h of PDT versus 5-FU, with AEs resolving sponta- exposure for optimal treatment results, as pre- neously in 5–7 and 27–30 days after treatment, viously recommended [1, 8]. At the end of the respectively. 2-h exposure, subjects removed the residual In terms of subject satisfaction, all five sub- MAL cream using wet towels and applied sun- jects reported that they preferred DL-PDT screen for continued protection. because of the lower incidence of AEs and the For the opposite treatment area, subjects rapid recovery compared with 5-FU. In addi- were instructed to apply 5-FU cream at home for tion, the single-day DL-PDT procedure (appli- a period of 21 days. Following cleansing of the cation of 16% MAL and exposure to sunlight) treatment area with soap and water, 5-FU cream renders this treatment option more convenient was applied homogeneously on the lesion and compared with the 21-day home application of surrounding area 1 h before bedtime to allow 5-FU for both the treating physician and the treatment to act throughout the night. In patient. the morning, the residual 5-FU cream was Figures 1 and 2 illustrate two subjects during removed with water, and SPF 30 sunscreen was the course of treatment and follow-up. applied. Dermatol Ther (Heidelb) (2018) 8:137–141 139 Fig. 1 Subject 1: a before treatment; b day 7 of 5-FU (right side of image) and day 0 of DL-PDT (left side of image); c day 14 of 5-FU and day 7 after DL-PDT; d day 95 after 5-FU and day 88 after DL-PDT Fig. 2 Subject 2: a before treatment; b day 7 of 5-FU (left side of image) and day 7 after DL-PDT (right side of image); c day 14 of 5-FU and day 14 after DL-PDT; d day 30 after 5-FU and day 30 after DL-PDT 140 Dermatol Ther (Heidelb) (2018) 8:137–141 DISCUSSION Medical Writing, Editorial, and Other Assistance. Editorial assistance in the prepara- The lesion complete response rate at 3 months tion of this manuscript was provided by Sotirios was higher for 5-FU compared with DL-PDT. Georgantopoulos, Ph.D., of SG Medical Writing However, although topical 5-FU remains an B.V. Support for this assistance was funded by efficacious option for the treatment of field of Galderma. cancerization, it is associated with disadvan- tages that may limit its effectiveness. The Disclosures. Dr. Gaston Galimberti has patient must adhere to the treatment for served as investigator/advisor for Galderma. 21 days while experiencing treatment-related Compliance with Ethics Guidelines. All AEs, which persist until the end of treatment subjects provided written informed consent and beyond. The prolonged duration of AEs prior to their participation in the study. may impair the social life of patients and con- sequently affect the effectiveness of the treat- Data Availability. My manuscript has no ment. The advantage of DL-PDT versus 5-FU lies associated data or the data will not be in the lack of systemic AEs. deposited. A limitation of this study is the small num- ber of subjects investigated. Studies with a larger Open Access. This article is distributed sample size are warranted to confirm these under the terms of the Creative Commons findings. Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/ CONCLUSIONS by-nc/4.0/), which permits any non- commercial use, distribution, and reproduction in any medium, provided you give appropriate Conclusively, DL-PDT is a favorable therapeutic credit to the original author(s) and the source, alternative compared with 5-FU with good effi- provide a link to the Creative Commons license, cacy and a better safety profile in terms of and indicate if changes were made. incidence and duration of AEs. These advan- tages allow patients to effectively treat their AK without compromising their social life. REFERENCES ACKNOWLEDGEMENTS 1. Grinblat B, Galimberti G, Chouela E, et al. Daylight- mediated photodynamic therapy for actinic damage in Latin America: consensus recommendations. Pho- Funding. Sponsorship for this study and todermatol Photoimmunol Photomed. 2016;32:81–7. article processing charges was funded by Gal- 2. Rahvar M, Lamel SA, Maibach HI.
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