Title : Short-term improvement and clinical success in patients with onychomycosis treated with topical ciclopirox 8%: Preliminary results of the EVOCA study
Abstract:
Onychomycosis is the most common nail disorder, and its topical treatment poses a therapeutic challenge due to the limited penetration of the drug through the nail plate. The EVOCA study evaluates the efficacy, safety, and impact on quality of life of a water-soluble nail lacquer containing 8% ciclopirox, formulated to enhance the penetration and concentration of the active ingredient in the nail.
The primary objective is to assess the clinical course of onychomycosis in patients treated for up to 48 weeks. Secondary objectives include evaluating clinical success and improvement according to the investigator’s assessment, changes in quality of life using the DLQI index, mycological cure determined by PCR, patient-reported perception, time to achieve clinical success, and the safety profile of the treatment.
EVOCA is a phase IV, multicenter, open-label, single-arm clinical study conducted at 9 centers in Spain. Adult patients with mild to moderate distal onychomycosis (10–40% nail involvement), confirmed by PCR, were included. Clinical improvement was defined as a ≥20% reduction in the affected area and clinical success as <10% involvement of the total nail area. Statistical analysis was performed using descriptive statistics for quantitative and qualitative variables. Comparisons were made using parametric or non-parametric tests, with a significance level of 0.05 and 95% confidence intervals, using SAS software version 9.4.
Of the 87 patients receiving treatment, 45 were included in the interim analysis and 37 completed week 12. The mean affected nail area, according to the investigator’s assessment, decreased from 20.8% at baseline to 16.8% at week 12. Clinical success was achieved in 13.5% of patients, and 37.5% showed clinical improvement. DLQI scores demonstrated a significant reduction (p = 0.042), indicating improved quality of life. One adverse event (2.2%) was reported, which was mild.
Interim results from the EVOCA study show that, in the short term, the water-soluble nail lacquer with 8% ciclopirox is associated with clinical improvement and success, with a favorable safety profile after 12 weeks of treatment, as well as a positive impact on patients’ quality of life and product evaluation. These findings support continuation of the study to confirm results after 48 weeks of treatment.
