Efficacy and Tolerability of Nixoderm Tin in the Management of Atopic Dermatitis: An Open-Label, Comparator-Controlled Clinical Study

Abstract

Background: Topical formulations combining salicylic acid, benzoic acid, and precipitated sulfur have been reported to support the management of atopic dermatitis (AD)/eczema by aiding skin exfoliation, reducing microbial load, and easing inflammation. Aims: The aim of the study is to evaluate the efficacy and tolerability of Nixoderm Tin, applied twice daily, in subjects with AD, compared with a control arm. Materials and Methods: An open-label, parallel-group study was conducted at a single center following ethics committee approval. Forty subjects diagnosed with AD per Hanifin-Rajka criteria were enrolled (Group A: Nixoderm Tin, n = 20; Group B: Control, n = 20) and assessed at day 0, 7, 15, and 30 using the eczema area and severity index (EASI) and AD severity index (ADSI), alongside a structured patient-feedback questionnaire. Results: Group A showed statistically significant reductions in EASI and ADSI scores from baseline to day 30 in both full analysis set (FAS) and per-protocol set (PPS) analyses, while Group B showed slight improvement in EASI and ADSI. Between-group differences were statistically significant (EASI PPS day 30, P = 0.0003; ADSI FAS day 30, P < 0.0001). No adverse events were reported in either arm. Patient-reported improvement in Group A rose to 80% by day 30. Conclusion: Nixoderm Tin demonstrated significant and well-tolerated improvement in AD severity over 30 days relative to control, supporting its potential role as a topical therapy for mild-to-moderate AD.