Efficacy and Tolerability of Nixoderm Cream 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) by aiding skin exfoliation, reducing microbial load, and easing inflammation. Aims: The aim of the study was to evaluate the efficacy and tolerability of Nixoderm Cream, 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 Centre following Ethics Committee approval. Forty two subjects diagnosed with AD per Hanifin–Rajka criteria were enrolled (Group A: Nixoderm Cream, n = 21; Group B: Control, n = 21) 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 and per-protocol set analyses, while Group B showed slight improvement in EASI and ADSI. Between-group differences were statistically significant. No adverse events were reported in either arm. Patient-reported improvement in Group A rose to 88% by day 30. Conclusion: Nixoderm Cream 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.