Comparative effect of tacrolimus and betamethasone valerate on the passive sustainable hydration of the stratum corneum in atopic dermatitis.

BACKGROUND: There is ample evidence that the skin barrier function is altered in atopic dermatitis. Little information is available about the effect of topical corticosteroids and calcineurin inhibitors on this function. PURPOSE: To assess the water content and its rate of accumulation in the stratum corneum of atopic patients using an indirect electrometric method while on tacrolimus or betamethasone valerate treatment. METHOD: Twenty-one patients with moderate atopic dermatitis affecting both forearms completed this double-blind randomized study. One forearm was treated twice daily for 3 weeks with 0.1% tacrolimus ointment. The other forearm was similarly treated with 0.12% betamethasone valerate ointment. Electrometric measurements were made under continuous occlusion secured by a Nova Dermal Phase Meter sensor probe. Assessments were performed at inclusion, after the 3-week treatment and after a further 3-week follow-up out of treatment. RESULTS: During treatment, both compounds yielded a similar improvement in skin barrier function. Indeed, under probe occlusion, the rate of water accumulation was significantly decreased. This improvement was sustained after stopping the tacrolimus treatment. By contrast, the benefit was in part lost at the site that had been treated by betamethasone valerate. CONCLUSION: The difference in the effect of the 2 compounds may be due to the negative influence of betamethasone valerate on the epidermal metabolism leading to progressive atrophy of the tissue. The better preservation of the skin barrier function after stopping tacrolimus treatment may help retarding relapses of atopic dermatitis

Avaliação da eficácia e segurança do tacrolimo pomada 0,03% no tratamento da dermatite atópica em pacientes pediátricos 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<0,001). Em relação a %BSA, houve redução de 30,4% e 55,5%, na primeira e na sexta semana. Houve redução do prurido em relação ao basal (p<0,001).Os eventos adversos mais comuns foram - queimação e prurido localizados. CONCLUSÃO - Tacrolimo pomada 0,03% é terapia segura e efetiva no tratamento da dermatite atópica leve a grave em pacientes pediátricos.<br>BACKGROUND: Tacrolimus ointment has been shown to be effective in treatment of atopic dermatitis. OBJECTIVES: To evaluate the efficacy and safety of 0.03% tacrolimus ointment (Protopic®) in pediatric patients with mild, moderate and severe atopic dermatitis. METHODS: Open, non-comparative, multicentric study carried out in Brazil. 174 patients (ages from two to 10) with mild to severe atopic dermatitis were included. Patients were instructed to apply Protopic® twice a day for six weeks. Primary efficacy criterion was clinical improvement > 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 frequentadverse 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