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Evaluation of the efficacy and safety of hydrogen peroxide in the treatment of molluscum contagiosum in children compared to potassium hydroxide: a pilot study
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"etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "Felipe de Paula" "apellidos" => "Saboia" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 2 => array:3 [ "nombre" => "Amanda" "apellidos" => "Hertz" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 3 => array:3 [ "nombre" => "Marcia" "apellidos" => "Olandoski" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 4 => array:3 [ "nombre" => "Dâmia Kuster Kaminski" "apellidos" => "Arida" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Department of Dermatology, Hospital Universitário Evangélico Mackenzie, Curitiba, PR, Brazil" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Department of Statistics, Pontifícia Universidade Católica do Paraná, Curitiba, PR, Brazil" "etiqueta" => "b" "identificador" => "aff0010" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig0015" "etiqueta" => "Figure 3" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr3.jpeg" "Alto" => 962 "Ancho" => 1675 "Tamanyo" => 52125 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0015" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Analysis of the number of lesions (A, Hydrogen peroxide; B, Potassium hydroxide; C, Placebo).</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Molluscum contagiosum (MC), an infectious dermatosis caused by a virus of the <span class="elsevierStyleItalic">Poxviridae</span> family,<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> mainly affects children, with transmission occurring through direct contact.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> It presents as 2 to 3 mm, rounded, pink, or normochromic papules, with central umbilication and a plug of caseous material.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Although considered a self-limited disease, its treatment alleviates discomfort, and prevents infectious complications, transmission, and self-inoculation,<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> refraining social marginalization of the patient and parental anxiety.</p><p id="par0015" class="elsevierStylePara elsevierViewall">There are several types of therapy for MC<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2–4</span></a> but many of these methods can generate uncomfortable effects that make adherence difficult, leading to therapeutic failure, anxiety and psychological trauma for children and families.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> A widely studied method is a 5% potassium hydroxide (KOH) solution, which, despite being effective, causes uncomfortable side effects, such as pain and dyschromia.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> Therefore, it is necessary to search for other treatment options that may bring more comfort and adherence to therapy. A promising option is hydrogen peroxide (H<span class="elsevierStyleInf">2</span>O<span class="elsevierStyleInf">2</span>). It has antimicrobial action through the oxidation of viral molecules, damaging their DNA and leading to cytotoxicity,<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> but without major damage to adjacent tissue. Thus, its adverse effects are generally mild.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> However, there is still a scarcity of studies demonstrating its real efficacy and safety.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Accordingly, this study evaluated the efficacy and safety of using H<span class="elsevierStyleInf">2</span>O<span class="elsevierStyleInf">2</span> 1% cream as MC treatment in pediatric patients. And, it was comparared with KOH 5% solution, through a double-blind, randomized, placebo-controlled pilot study with 30 patients with MC, aged 2 to 16 years, who had had no treatment for the disease in the previous six months, randomly allocated into three treatment groups following the order of arrival. Group A was submitted to treatment with H<span class="elsevierStyleInf">2</span>O<span class="elsevierStyleInf">2</span> 1% cream; Group B, treatment with KOH 5% solution; Group C, treatment with Lanette cream (placebo), all applied twice a day, continuously used until the lesions became irritated. The participants were evaluated every 4 weeks for three months through photographic records and clinical evaluation by a dermatologist blinded to the intervention, regarding the number of lesions, their reduction, and side effects. Parents perception was also recorded throughout a specific questionnaire. Of the 30 patients, seven did not complete the study (five due to poor adherence to treatment; one due to loss of follow-up; and one due to an adverse effect of KOH), leaving 23 individuals - eight in Group A, seven in Group B and eight in Group C.</p><p id="par0025" class="elsevierStylePara elsevierViewall">Regarding the percentage reduction of lesions (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>), in the 4th week, there was a greater reduction of 50% of lesions in almost 40% of the patients in Group A, close to Group B (42.9%; p = 1) and higher than Group C (25%; p = 1). In the 12th week, this reduction reached 85% of the patients in Group A, lower than in Group B (100%), but higher than in Group C (62.5%; p = 1).</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">The absolute reduction in the number of total lesions (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a>), considering the sum of all patients, was 20.7% in Group A in the 4th week, lower than that obtained in Group B (41.2%; p = 0.265). Both Group A and Group B showed higher values than the placebo group, which on the other hand showed an increase in the number of lesions during this period. In the 12th week, 73.2% of the lesions had resolved in Group A (p = 0.034), lower than the 98.4% reduction seen in Group B (p = 0.034), but higher than in Group C (45.5%; p = 0.034).</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0035" class="elsevierStylePara elsevierViewall">It was also observed that Group A showed greater variability in results between patients, while Group B showed almost no dispersion. Although Group C also had cases of improvement, there were cases of worsening of the condition (<a class="elsevierStyleCrossRef" href="#fig0015">Fig. 3</a>).</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0040" class="elsevierStylePara elsevierViewall">Regarding parents perception of side effects, from the 4th to 12th week (p = 1, p = 1, p = 0.846), 50% of the patients in Group A experienced some adverse event. In Group B, 70% of the patients experienced adverse effects in the 4th week, 42.9% in the 8th week and more than 80% in the 12th week (p = 1, p = 1, p = 0.846, respectively). There were also reports of adverse effects in Group C, 37.5%, 25% and 75% in weeks 4, 8 and 12, respectively, which can be attributed to symptoms of the natural evolution of the disease.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">Of the reported side effects, erythema was present in 37.5% of the patients in Group A in the 4th week, similar to what was found in Group C (37.5%; p = 1) and lower than that in Group B (57.1%; p = 1). In the 12th week, Group A showed more erythema when compared to the other groups (A: 37.5%; B: 14.3%; C: 12.5%; p = 1).</p><p id="par0050" class="elsevierStylePara elsevierViewall">As for crusts, they were present in 25% of the patients in Group A in the 4th week and absent in the 8th and 12th weeks, while in Group B, they were present in 14.4% throughout all weeks, close to the values in Group C (13%; p = 1).</p><p id="par0055" class="elsevierStylePara elsevierViewall">As for erosions/ulcers, Groups A and C did not show them in any of the evaluations, whereas 14.3% of all patients in Group B had these signals in the 12th week.</p><p id="par0060" class="elsevierStylePara elsevierViewall">Pruritus was more prevalent in Group A compared to the two other groups in all weeks, affecting 25% of children in the 12th week. Group B, on the other hand, did not report pruritus, unlike other studies, in which this symptom is a common finding.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a></p><p id="par0065" class="elsevierStylePara elsevierViewall">Burning/pain sensation was present in 12.5% of individuals in Group A in all weeks, the same as in Group C (12.5%). In Group B, this value was almost four times higher in the 4th week (57.1%; p = 0.357); and reached 71.4% of the patients in the 12th week (p = 0.122).</p><p id="par0070" class="elsevierStylePara elsevierViewall">In Group A, 25% of the children had dyschromia in the 12th week, lower than what was seen in Group C (37.5%, p = 1) and also Group B, which had 71.4% in the 4th week (p = 0.021), with persistence of the condition in almost half of the patients in the 12th week (42.9%; p = 1).</p><p id="par0075" class="elsevierStylePara elsevierViewall">It can be concluded that the use of H<span class="elsevierStyleInf">2</span>O<span class="elsevierStyleInf">2</span> showed a tendency towards superior efficacy in relation to the placebo, but still lower than that of KOH. However, it seems to be a promising therapy due to its safety and lower incidence of side effects such as burning sensation, pain and dyschromia. Due to these findings, it may be a good option for younger children, with more sensitive skin and intolerant to the adverse manifestations caused by KOH. As this is a pilot study with a small sample, it did not obtain the necessary statistical significance to allow a conclusion on the real effectiveness of H<span class="elsevierStyleInf">2</span>O<span class="elsevierStyleInf">2</span>, requiring further larger sample studies to guarantee statistically significant efficacy and safety results.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Financial support</span><p id="par0080" class="elsevierStylePara elsevierViewall">We had financial support from FUNADERM (Fundo de Apoio à Dermatologia).</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Authors’ contributions</span><p id="par0085" class="elsevierStylePara elsevierViewall">Elinah Narumi Inoue: Data collection, analysis and interpretation of data; drafting and editing of the manuscript; collection, analysis and interpretation of data; critical review of the literature.</p><p id="par0090" class="elsevierStylePara elsevierViewall">Felipe de Paula Saboia: Data collection.</p><p id="par0095" class="elsevierStylePara elsevierViewall">Amanda Hertz: Data collection.</p><p id="par0100" class="elsevierStylePara elsevierViewall">Marcia Olandoski: Statistical analysis.</p><p id="par0105" class="elsevierStylePara elsevierViewall">Dâmia Kuster Kaminski Arida: Design and planning of the study; data collection, or analysis and interpretation of data; drafting and editing of the manuscript or critical review of important intellectual content; collection, analysis and interpretation of data; effective participation in research orientation; intellectual participation in the propaedeutic and/or therapeutic conduct of the studied cases; approval of the final version of the manuscript.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Conflicts of interest</span><p id="par0110" class="elsevierStylePara elsevierViewall">None declared.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Financial support" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Authors’ contributions" ] 2 => array:2 [ "identificador" => "sec0015" "titulo" => "Conflicts of interest" ] 3 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2023-07-17" "fechaAceptado" => "2023-10-10" "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Study conducted at the Pediatric Dermatology Outpatient Clinic, Department of Dermatology, Hospital Universitário Evangélico Mackenzie, Curitiba, PR, Brazil.</p>" ] ] "multimedia" => array:3 [ 0 => array:8 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1199 "Ancho" => 1675 "Tamanyo" => 152069 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0005" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Reduction of ≥ 50% of lesions (A, Hydrogen peroxide; 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