Safety and efficacy of methylprednisolone aceponate 0.1% cream with respect to brand formulation of the same composition in patients with uncomplicated idiopathic eczema: Results of the postmarketing study
Abstract
Introduction. Eczema is a common inflammatory skin disease characterized by pruritus, impaired quality of life, and the need for safe anti-inflammatory therapy. Aim. To evaluate the safety and efficacy of two cream formulations containing methylprednisolone aceponate in patients with uncomplicated eczema. Materials and methods. A postmarketing, open-label, comparative, randomized, parallel-group, phase IV study was conducted at three study sites in the Russian Federation. The study population included patients aged 18–70 years with acute or subacute uncomplicated idiopathic eczema affecting no more than 10% of the body surface area. 228 patients were randomised to receive either Komfoderm® K (n = 114) (intervention group) or Advantan® (n = 114) (comparator group). The drugs were applied topically once daily for 2 weeks, with follow-up period of 21 ± 2 days. The primary endpoint was the overall rate of adverse events over 3 weeks. The secondary endpoints included changes in the EASI, the pruritus intensity on VAS (100-mm line), the DLQI, and the sum of 7 eczema symptom scores. Results. Any adverse event was reported in 4/114 patients (3.5%; 95% CI 1.0–8.7) in the intervention group and 3/114 (2.6%; 95% CI 0.5–7.5) in the comparator group; no statistically significant differences between the groups (p > 0.999). All adverse events were defined as mild, non-serious, and not related to both drugs. By day 14, differences in LS-mean percentage change in EASI score was 2.42% (95% CI -1.17; 6.02), which met the criterion for comparable efficacy. Intergroup differences in EASI, VAS, DLQI, and 7 symptoms scores were not statistically significant. Conclusions. Both drugs demonstrated a favourable safety profile and comparable clinical efficacy in the 2-week treatment of uncomplicated idiopathic eczema. The patented ceramide-based formulation can be considered as an additional pharmaceutical characteristic of the drug in line with the targets to restore the epidermal barrier.