L Torezan1, B Grinblat1, M Haedersdal2, N Valente1, C Festa-Neto1, R M Szeimies3. 1. Department of Dermatology, Universidade de São Paulo, Hospital das Clínicas, São Paulo, Brazil. 2. Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark. 3. Department of Dermatology and Allergology, Klinikum Vest GmbH, Recklinghausen, Germany.
Abstract
BACKGROUND:Topical photodynamic therapy (PDT) is an approved treatment for actinic keratosis (AK). To enhance the efficacy of PDT for AKs, physical and chemical pretreatments have been suggested. OBJECTIVES: To compare the efficacy and safety of the combination of topical calcipotriol (CAL) before methyl aminolaevulinate (MAL)-PDT for AKs of the scalp vs. conventional MAL-PDT in a randomized controlled clinical trial. METHODS:Twenty patients with multiple AKs on the scalp were randomized to receive conventional MAL-PDT with previous curettage on one side of the scalp and CAL-assisted MAL-PDT once a day for 15 days before illumination on the other side. After 3 months, patients were evaluated for clearance of AKs, side-effects and histopathology before and after the procedure. Protoporphyrin IX (PpIX) fluorescence was measured before and after illumination on both sides. RESULTS:All 20 patients completed the study. Overall AK clearance rates were 92·1% and 82·0% for CAL-PDT and conventional PDT, respectively (P < 0·001). Grade 1 AKs showed similar response rates for both sides (P = 0·055). However, grade II AKs showed more improvement on the CAL-PDT side (90%) than on the MAL-PDT side (63%) (P < 0·001). Before illumination, PpIX fluorescence intensity was higher on the CAL-assisted side (P = 0·048). The treatment was more painful on the CAL-PDT side, although well tolerated. The mean visual analogue scale score was 5·4 ± 1·4 on the CAL-PDT side and 4·0 ± 0·69 on the conventional MAL-PDT side (P = 0·001). Side-effects such as erythema (P = 0·019), oedema (P = 0·002) and crusts (P < 0·001) were more pronounced on the CAL-assisted side. Histopathological analyses were obtained from five patients and both sides showed improved keratinocyte atypia following PDT, with slightly more improvement on the CAL-assisted side. CONCLUSIONS:CAL-assisted PDT proved to be safe and more effective than conventional MAL-PDT for the treatment of AKs on the scalp. CAL pretreatment increased PpIX accumulation within the skin and may have enhanced the efficacy in this first human trial.
RCT Entities:
BACKGROUND: Topical photodynamic therapy (PDT) is an approved treatment for actinic keratosis (AK). To enhance the efficacy of PDT for AKs, physical and chemical pretreatments have been suggested. OBJECTIVES: To compare the efficacy and safety of the combination of topical calcipotriol (CAL) before methyl aminolaevulinate (MAL)-PDT for AKs of the scalp vs. conventional MAL-PDT in a randomized controlled clinical trial. METHODS: Twenty patients with multiple AKs on the scalp were randomized to receive conventional MAL-PDT with previous curettage on one side of the scalp and CAL-assisted MAL-PDT once a day for 15 days before illumination on the other side. After 3 months, patients were evaluated for clearance of AKs, side-effects and histopathology before and after the procedure. Protoporphyrin IX (PpIX) fluorescence was measured before and after illumination on both sides. RESULTS: All 20 patients completed the study. Overall AK clearance rates were 92·1% and 82·0% for CAL-PDT and conventional PDT, respectively (P < 0·001). Grade 1 AKs showed similar response rates for both sides (P = 0·055). However, grade II AKs showed more improvement on the CAL-PDT side (90%) than on the MAL-PDT side (63%) (P < 0·001). Before illumination, PpIX fluorescence intensity was higher on the CAL-assisted side (P = 0·048). The treatment was more painful on the CAL-PDT side, although well tolerated. The mean visual analogue scale score was 5·4 ± 1·4 on the CAL-PDT side and 4·0 ± 0·69 on the conventional MAL-PDT side (P = 0·001). Side-effects such as erythema (P = 0·019), oedema (P = 0·002) and crusts (P < 0·001) were more pronounced on the CAL-assisted side. Histopathological analyses were obtained from five patients and both sides showed improved keratinocyte atypia following PDT, with slightly more improvement on the CAL-assisted side. CONCLUSIONS: CAL-assisted PDT proved to be safe and more effective than conventional MAL-PDT for the treatment of AKs on the scalp. CAL pretreatment increased PpIX accumulation within the skin and may have enhanced the efficacy in this first human trial.
Authors: Nathalie C Zeitouni; Neal Bhatia; Roger I Ceilley; Joel L Cohen; James Q Del Rosso; Angela Y Moore; Gilly Munavalli; David M Pariser; Todd Schlesinger; Daniel M Siegel; Andrea Willey; Mitchel P Goldman Journal: J Clin Aesthet Dermatol Date: 2021-10
Authors: Andrzej T Slominski; Anna A Brożyna; Tae-Kang Kim; Mahmoud M Elsayed; Zorica Janjetovic; Shariq Qayyum; Radomir M Slominski; Allen S W Oak; Changzhao Li; Ewa Podgorska; Wei Li; Anton M Jetten; Robert C Tuckey; Edith K Y Tang; Craig Elmets; Mohammad Athar Journal: Int J Oncol Date: 2022-07-01 Impact factor: 5.884
Authors: Taylor A Bullock; Jeffrey Negrey; Bo Hu; Christine B Warren; Tayyaba Hasan; Edward V Maytin Journal: J Am Acad Dermatol Date: 2022-03-18 Impact factor: 15.487
Authors: Andrzej T Slominski; Anna A Brożyna; Michal A Zmijewski; Zorica Janjetovic; Tae-Kang Kim; Radomir M Slominski; Robert C Tuckey; Rebecca S Mason; Anton M Jetten; Purushotham Guroji; Jörg Reichrath; Craig Elmets; Mohammad Athar Journal: Adv Exp Med Biol Date: 2020 Impact factor: 2.622
Authors: Urvashi Kaw; Muneeb Ilyas; Taylor Bullock; Lisa Rittwage; Margo Riha; Allison Vidimos; Bo Hu; Christine B Warren; Edward V Maytin Journal: J Am Acad Dermatol Date: 2019-09-13 Impact factor: 11.527