Multicentric open clinical study of the efficacy and tolerability of adapalene 0.1% gel* in patients with acne vulgaris

FUNDAMENTOS - O adapaleno é um derivado do ácido naftóico, com propriedades biológicas similares às do ácido retinóico e utilizado no tratamento da acne vulgar. OB J E T I VO S - Avaliar a eficácia e a tolerabilidade do adapaleno 0,1% gel no tratamento da acne vulgar leve à moderada, em pacientes residentes no Brasil. MAT E R I A I S EMÉ T O D O S - Os pacientes aplicaram o gel à noite, durante 12 semanas, e foram avaliados quanto à efetividade pelo número de lesões em cada visita e quanto à tolerabilidade ao produto nas consultas da segunda e da décima segunda semana. RE S U LTA D O S - Dos 125 pacientes, 81,6% completaram as 12 semanas de tratamento, e 10,4% dos casos terminaram o estudo antes do período estabelecido por estarem livres de lesões. Os resultados permitem confirmar a marcante atividade antiinflamatória, antiproliferativa e na diferenciação celular dos ceratinócitos. Houve diminuição dos comedões e das lesões inflamatórias, com resposta satisfatória no eritema, no ressecamento e na descamação da pele. Efeitos adversos pouco graves foram relatados em apenas 9,6% dos pacientes. CO N C LU S Õ E S - O adapaleno, neste estudo e nos vários que o antecederam, vem-se mostrando uma das melhores opções de tratamento tópico para os casos leves a moderados de acne vulgar. Palavras-chave: acne vulgar; terapêutica; tretinoína.BA C K G R O U N D - Adapalene, a naftoic acid derivative with biological properties similar to those of the retinoic acid, is indicated in the treatment of acne vulgaris. OBJECTIVES - The present study was carried out to evaluate the therapeutic action of adapalene 0.1% gel and its tolerability in the treatment of mild to moderate acne vulgaris in patients living in Brazil. MATERIAL AND METHODS - Patients applied the gel at night for 12 weeks; and were evaluated regarding the efficacy and tolerability of the pro - duct according to the number of lesions observed at each of the 2-week and 12-week visits. RESULTS - Out of 125 patients, 81.6% completed 12 weeks of therapy and 10.4% of the cases left the study before week 12 because they were found to be lesion-free. Results allow us to confirm its effect upon keratinocyte cellular differentiation with antiinflammatory and antipro - liferative properties. Adapalene induces a marked decrease in comedos and inflammatory lesions. Mild adverse events were reported in less than 10% of patients. CONCLUSION - Adapalene has been shown to be one of the best topical therapies for mild or moderate acne both in the present study and in previous studies

Multicentric open clinical study of the efficacy and tolerability of adapalene 0.1% gel* in patients with acne vulgaris

FUNDAMENTOS - O adapaleno é um derivado do ácido naftóico, com propriedades biológicas similares às do ácido retinóico e utilizado no tratamento da acne vulgar. OB J E T I VO S - Avaliar a eficácia e a tolerabilidade do adapaleno 0,1% gel no tratamento da acne vulgar leve à moderada, em pacientes residentes no Brasil. MAT E R I A I S EMÉ T O D O S - Os pacientes aplicaram o gel à noite, durante 12 semanas, e foram avaliados quanto à efetividade pelo número de lesões em cada visita e quanto à tolerabilidade ao produto nas consultas da segunda e da décima segunda semana. RE S U LTA D O S - Dos 125 pacientes, 81,6% completaram as 12 semanas de tratamento, e 10,4% dos casos terminaram o estudo antes do período estabelecido por estarem livres de lesões. Os resultados permitem confirmar a marcante atividade antiinflamatória, antiproliferativa e na diferenciação celular dos ceratinócitos. Houve diminuição dos comedões e das lesões inflamatórias, com resposta satisfatória no eritema, no ressecamento e na descamação da pele. Efeitos adversos pouco graves foram relatados em apenas 9,6% dos pacientes. CO N C LU S Õ E S - O adapaleno, neste estudo e nos vários que o antecederam, vem-se mostrando uma das melhores opções de tratamento tópico para os casos leves a moderados de acne vulgar. Palavras-chave: acne vulgar; terapêutica; tretinoína.BA C K G R O U N D - Adapalene, a naftoic acid derivative with biological properties similar to those of the retinoic acid, is indicated in the treatment of acne vulgaris. OBJECTIVES - The present study was carried out to evaluate the therapeutic action of adapalene 0.1% gel and its tolerability in the treatment of mild to moderate acne vulgaris in patients living in Brazil. MATERIAL AND METHODS - Patients applied the gel at night for 12 weeks; and were evaluated regarding the efficacy and tolerability of the pro - duct according to the number of lesions observed at each of the 2-week and 12-week visits. RESULTS - Out of 125 patients, 81.6% completed 12 weeks of therapy and 10.4% of the cases left the study before week 12 because they were found to be lesion-free. Results allow us to confirm its effect upon keratinocyte cellular differentiation with antiinflammatory and antipro - liferative properties. Adapalene induces a marked decrease in comedos and inflammatory lesions. Mild adverse events were reported in less than 10% of patients. CONCLUSION - Adapalene has been shown to be one of the best topical therapies for mild or moderate acne both in the present study and in previous studies

Evaluate of the efficacy and safety of tacrolimus ointment 0,03% to treat atopic dermatitis in pediatric patients

FUNDAMENTOS – Tacrolimo pomada é eficaz no tratamento da dermatite atópica. OBJETIVOS – Avaliar a eficácia e segurança do tacrolimo pomada 0,03% (Protopic®) no tratamento de pacientes pediátricos com dermatite atópica. MÉTODOS – Estudo multicêntrico, aberto e não comparativo. Incluídos 174 pacientes (dois a 10 anos) com dermatite atópica. Utilizou-se tacrolimo duas vezes ao dia, por seis semanas. O critério primário de eficácia foi a melhora clínica > a 90% avaliada pelo médico (Escala de Avaliação Global da Resposta Clínica). Outros critérios de eficácia foram a redução no índice de área e gravidade do eczema (EASI), a redução do percentual de superfície corporal afetada (%BSA) e a avaliação do prurido pelo paciente (escala analógica visual). Segurança foi avaliada pela ocorrência de eventos adversos relatados pelos pais e pacientes ou pelos investigadores. RESULTADOS – Trinta e três por cento dos pacientes apresentaram melhora clínica >90%. Quando avaliado o escore EASI, houve redução de 45,5% (primeira semana) e 61,8% (sexta semana) quando comparado com o basal (p 90% assessed by the physician (Clinical Response Global Evaluation Scale). Other efficacy criteria included reduction of the Eczema Area Severity Index (EASI), decrease of the affected body surface area (%BSA) and evaluation of the itching by the patients or their guardians (visual analogical scale). Safety was evaluated by adverse events reported by patients and/or guardians or by investigators. RESULTS: Thirty-three percent of patients showed clinical improvement >90%. 45.5% of patients (1st week) decreased EASI and 61.8% (6th week) (p<0,001). %BSA decreased 30.4% and 55.5% in the first and sixth week. Improvement was also significant when measured by itching (p<0,001). Most frequent adverse effects were: burning and itching. CONCLUSION: 0.03% tacrolimus ointment is a safe and effective therapy for mild to severe atopic dermatitis in pediatric patients

Evaluate of the efficacy and safety of tacrolimus ointment 0,03% to treat atopic dermatitis in pediatric patients

FUNDAMENTOS – Tacrolimo pomada é eficaz no tratamento da dermatite atópica. OBJETIVOS – Avaliar a eficácia e segurança do tacrolimo pomada 0,03% (Protopic®) no tratamento de pacientes pediátricos com dermatite atópica. MÉTODOS – Estudo multicêntrico, aberto e não comparativo. Incluídos 174 pacientes (dois a 10 anos) com dermatite atópica. Utilizou-se tacrolimo duas vezes ao dia, por seis semanas. O critério primário de eficácia foi a melhora clínica > a 90% avaliada pelo médico (Escala de Avaliação Global da Resposta Clínica). Outros critérios de eficácia foram a redução no índice de área e gravidade do eczema (EASI), a redução do percentual de superfície corporal afetada (%BSA) e a avaliação do prurido pelo paciente (escala analógica visual). Segurança foi avaliada pela ocorrência de eventos adversos relatados pelos pais e pacientes ou pelos investigadores. RESULTADOS – Trinta e três por cento dos pacientes apresentaram melhora clínica >90%. Quando avaliado o escore EASI, houve redução de 45,5% (primeira semana) e 61,8% (sexta semana) quando comparado com o basal (p 90% assessed by the physician (Clinical Response Global Evaluation Scale). Other efficacy criteria included reduction of the Eczema Area Severity Index (EASI), decrease of the affected body surface area (%BSA) and evaluation of the itching by the patients or their guardians (visual analogical scale). Safety was evaluated by adverse events reported by patients and/or guardians or by investigators. RESULTS: Thirty-three percent of patients showed clinical improvement >90%. 45.5% of patients (1st week) decreased EASI and 61.8% (6th week) (p<0,001). %BSA decreased 30.4% and 55.5% in the first and sixth week. Improvement was also significant when measured by itching (p<0,001). Most frequent adverse effects were: burning and itching. CONCLUSION: 0.03% tacrolimus ointment is a safe and effective therapy for mild to severe atopic dermatitis in pediatric patients

Consensus on the diagnostic and therapeutic management of chronic spontaneous urticaria in adults : Brazilian Society of Dermatology

Background: Urticarias are frequent diseases, with 15% to 20% of the population presenting at least one acute episode in their lifetime. Urticaria are classified in acute (≤ 6 weeks) or chronic (> 6 weeks). They may be induced or spontaneous. Objectives: To verify the diagnostic and therapeutic recommendations in chronic spontaneous urticaria (CSU), according to the experience of Brazilian experts, regarding the available guidelines (international and US). Methods: A questionnaire was sent to Brazilian experts, with questions concerning diagnostic and therapeutic recommendations for CSU in adults. Results: Sixteen Brazilian experts answered the questionnaire related to diagnosis and therapy of CSU in adults and data were analyzed. Final text was written, considering the available guidelines (International and US), adapted to the medical practices in Brazil. Diagnostic work up in CSU is rarely necessary. Biopsy of skin lesion and histopathology may be indicated to rule out other diseases, such as, urticarial vasculitis. Other laboratory tests, such as complete blood count, CRP, ESR and thyroid screening. Treatment of CSU includes second-generation anti-histamines (sgAH) at licensed doses, sgAH two, three to fourfold doses (non-licensed) and omalizumab. Other drugs, such as, cyclosporine, immunomodulatory drugs and immunosuppressants may be indicated (non-licensed and with limited scientific evidence). Conclusions: Most of the Brazilian experts in this study partially agreed with the diagnostic and therapeutic recommendations of the International and US guidelines. They agreed with the use of sgAH at licensed doses. Increase in the dose to fourfold of sgAH may be suggested with restrictions, due to its non-licensed dose. Sedating anti-histamines, as suggested by the US guideline, are indicated by some of the Brazilian experts, due to its availability. Adaptations are mandatory in the treatment of CSU, due to scarce or lack of other therapeutic resources in the public health system in Brazil, such as omalizumab or cyclosporine

Estudo clínico aberto multicêntrico da efetividade e tolerabilidade do gel de adapaleno a 0,1%* em pacientes com acne vulgar Multicentric open clinical study of the efficacy and tolerability of adapalene 0.1% gel* in patients with acne vulgaris

FUNDAMENTOS: O adapaleno é um derivado do ácido naftóico, com propriedades biológicas similares às do ácido retinóico e utilizado no tratamento da acne vulgar. OBJETIVOS: Avaliar a eficácia e a tolerabilidade do adapaleno 0,1% gel no tratamento da acne vulgar leve à moderada, em pacientes residentes no Brasil. MATERIAIS E MÉTODOS: Os pacientes aplicaram o gel à noite, durante 12 semanas, e foram avaliados quanto à efetividade pelo número de lesões em cada visita e quanto à tolerabilidade ao produto nas consultas da segunda e da décima segunda semana. RESULTADOS: Dos 125 pacientes, 81,6% completaram as 12 semanas de tratamento, e 10,4% dos casos terminaram o estudo antes do período estabelecido por estarem livres de lesões. Os resultados permitem confirmar a marcante atividade antiinflamatória, antiproliferativa e na diferenciação celular dos ceratinócitos. Houve diminuição dos comedões e das lesões inflamatórias, com resposta satisfatória no eritema, no ressecamento e na descamação da pele. Efeitos adversos pouco graves foram relatados em apenas 9,6% dos pacientes. CONCLUSÕES: O adapaleno, neste estudo e nos vários que o antecederam, vem-se mostrando uma das melhores opções de tratamento tópico para os casos leves a moderados de acne vulgar.<br>BACKGROUND: Adapalene, a naftoic acid derivative with biological properties similar to those of the retinoic acid, is indicated in the treatment of acne vulgaris. OBJECTIVES: The present study was carried out to evaluate the therapeutic action of adapalene 0.1% gel and its tolerability in the treatment of mild to moderate acne vulgaris in patients living in Brazil. MATERIAL AND METHODS: Patients applied the gel at night for 12 weeks; and were evaluated regarding the efficacy and tolerability of the product according to the number of lesions observed at each of the 2-week and 12-week visits. RESULTS: Out of 125 patients, 81.6% completed 12 weeks of therapy and 10.4% of the cases left the study before week 12 because they were found to be lesion-free. Results allow us to confirm its effect upon keratinocyte cellular differentiation with antiinflammatory and antiproliferative properties. Adapalene induces a marked decrease in comedos and inflammatory lesions. Mild adverse events were reported in less than 10% of patients. CONCLUSION: Adapalene has been shown to be one of the best topical therapies for mild or moderate acne both in the present study and in previous studies