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Advances in dermatology and venereology Acta Dermato-Venereologica
Laser-assisted Photodynamic Therapy or Laser-assisted Amorolfine Lacquer Delivery for Treatment of Toenail Onychomycosis : An Open-label Comparative Study
Amir KOREN 1 , Fares SALAMEH 1 , Eli SPRECHER 1 , 2 and Ofir ARTZI 1 *
1
Department of Dermatology , Tel Aviv Medical Center , 6 Weizman Street , Tel Aviv 6423906 , and 2 Department of Human Molecular Genetics & Biochemistry , Sackler Faculty of Medicine , Tel Aviv University , Tel Aviv , Israel . * E-mail : benofir @ gmail . com Accepted Dec 20 , 2017 ; Epub ahead of print Dec 21 , 2017
Oral antifungal medications are considered the gold standard therapy for onychomycosis . Topical antifungal treatments are less efficacious , mainly due to their limited penetration through the nail plate into the nail bed at fungicidal concentrations ( 1 ). In the last decade , the use of lasers and photodynamic therapy ( PDT ) has been used as an alternative treatment for onychomycosis , with varying clinical and microbiological results ( 1 , 2 ). Pretreatment with ablative fractional lasers ( AFR ) increases the permeation and absorption of topical drugs and improves efficacy ( 3 – 8 ).
The aim of this study was to assess the efficacy of fractional ablative CO 2 laser ( FACL ) -assisted delivery of 20 % aminolaevulinic acid ( ALA ) -PDT and of 5 % amorolfine ( as nail lacquer ) in achieving clinical and mycological cure of toenail onychomycosis .
MATERIALS AND METHODS
This open-label comparative study included 60 patients , age range 18 – 60 years , with typical clinical finding and positive mycological culture of bilateral toenail onychomycosis . All participants provided written informed consent according to a protocol approved by the Tel Aviv Medical Center institutional review board in accordance with the prin ciples of the Declaration of Helsinki . Exclusion criteria included : systemic antifungal treatment during the previous 12 months , concomitant nail disease , vascular or microcirculatory disorders , metabolic diseases , including diabetes mellitus , immunodeficiency states , paresis and paralysis caused by injuries to the central or peripheral nervous system , pregnancy , and porphyria , photosensitive dermatoses , and allergy to components of the photosensitizer compound for patients who were assigned to be treated with PDT . Patients who failed to comply with the treatment regimen and those who experienced discomfort and unusual side-effects due to the treatment were subsequently excluded .
All patients received 6 treatment sessions at 3-week intervals . The patients were randomly assigned to 2 study groups ( groups A and B ). Group A patients had 20 % -ALA applied to the toenails and kept under occlusion using an opaque shield for 3 h . At the end of the incubation period , red light ( 630 nm ) illumination was delivered from a non-coherent light source ( Aktilite , Galderma ) at a dose of 75 J / cm 2 . Group B patients ’ toenails were painted with 5 % amorolfine nail lacquer , and the patients were instructed to re-apply the nail lacquer once a week . Prior to undergoing PDT ( group A ) or the topical application of 5 % amorolfine nail lacquer ( group B ), the toes of the right foot were pretreated with FACL ( Lumenis , UltraPulse , Yokneam , Israel , Setting : SCAARFX mode . Energy : 150 mJ , density : 3 %, one pass , small spot size ). Prior to laser treatment , 5 % EMLA cream ( AstraZeneca AB , Södertälje , Sweden ) was applied under occlusion to the infected nail and periungual skin for 60 min .
Standardized photographs and mycological cultures were obtained at baseline and at 3 months ( first follow-up ) and 9 months ( second follow-up ) after the final treatment . All toenails were photographed with a digital camera ( Canon EOD 70D ) using a 100-mm macro objective and flash ( Canon Macro 100 mm ). The baseline and follow-up photographs were compared by 2 dermatologists using a 0 – 5 grading scale ( 8 ), where : 5 = complete response ( fully normal-appearing nail measured from the proximal nail fold to involved nail ), 4 = very significant response (> 75 % normalappearing nail , compared with the area of the initially infected nail ), 3 = significant response ( 50 – 75 % normal-appearing nail ), 2 = moderate response ( 25 – 50 % normal-appearing nail ), 1 = small improvement (< 25 % normal-appearing nail ), and 0 = no response to treatment . The dermatologists were blinded to the study groups and to the side of treatment . The first toe was evaluated if it was infected on both sides . If not , the other toes were evaluated .
At each treatment session the patients were asked to evaluate any treatment-related pain using a 10-cm visual analogue scale , from 0 ( no pain ) to 10 ( extremely painful ). At the 2 follow-up visits , they indicated their degree of satisfaction using the 5-point Likert scale : 5 = very satisfied , 4 = satisfied , 3 = neither satisfied nor dissatisfied , 2 = dissatisfied , and 1 = very dissatisfied .
Continuous measurements were summarized using means ± standard deviations ( SD ), and categorical measurements were summarized using counts and percentages . Comparisons of continuous measurements between the 2 study groups were carried out using the independent t-test . Comparisons of categorical measurements were performed using the Fisher ’ s exact test . The McNemar ’ s test was used for paired analysis between sides within the study groups . Significance was defined as p = 0.05 . The analyses were carried out using SPSS 24.01 .
RESULTS
A total of 60 patients were enrolled in the study , of whom 56 ( 30 in group A and 26 in group B ), whose mean age was 49 years ( range 26 – 66 years ), completed the study . Four patients dropped out due to lack of compliance . The mean disease duration was 11.7 years . Most of the patients ( 73 %) had severe onychomycosis . The mean onychomycosis severity index ( OSI ) score ( 9 ) was 23.6 . Fungal cultures revealed Trichophyton rubrum in the majority ( 94.6 %) of patients .
A comparison of the percentages of positive fungal cultures at the 2 follow-up visits revealed no significant differences between the treatment and the control sides of both treatment groups ( Fig . 1 ). While the percentage of positive cultures was less than 50 % in both treatment groups at 3 months following the last treatment , it grew considerably at the second follow-up visit ( 9 months follow ing the last treatment ) for both treatment groups
This is an open access article under the CC BY-NC license . www . medicaljournals . se / acta Journal Compilation © 2018 Acta Dermato-Venereologica . doi : 10.2340 / 00015555-2874 Acta Derm Venereol 2018 ; 98 : 467 – 468