Supramolecular Salicylic Acid Chemical Peeling Combined with Supramolecular Active Zinc for Malassezia Folliculitis: Efficacy and Safety from a Multicenter, Single-Arm Trial.

INTRODUCTION

Traditional antifungal therapy for Malassezia folliculitis (MF) is often associated with high recurrence rates and limited long-term options. This study evaluated the efficacy and safety of 30% supramolecular salicylic acid (SSA) combined with supramolecular active zinc (SAZ) in adults with moderate-to-severe Malassezia folliculitis.

METHODS

In this 12-week, multicenter, single-arm trial, adults with moderate-to-severe (grade 2-3) MF received weekly 30% SSA peeling for 8 weeks combined with once-daily topical SAZ application. The primary end point was the overall efficacy rate at week 8 in the full analysis set (FAS), based on skin lesion reduction and Malassezia microscopy. Secondary end points included symptom response rates (pruritus, scaling, erythema, greasiness), recurrence rate, patient satisfaction, and quality-of-life (QoL) outcomes.

RESULTS

The overall efficacy rate at week 8 was 95.42% (95% confidence interval [CI] 91.95-97.69%) in the FAS (n = 240) and 99.52% (95% CI 97.35-99.99%) in the per-protocol set (PPS; n = 212). Clinically meaningful improvements were observed from week 2 (69.17%). By week 8, erythema (94.76%), greasiness (95.24%), pruritus (90.95%), and scaling (86.67%) had all responded. During the 4-week post-treatment follow-up, recurrence was observed in 2 of 237 patients included in the FAS recurrence analysis (0.84%). Treatment-related adverse events (AEs) occurred in 2.92% of patients and were all mild-to-moderate; no serious AEs were reported.

CONCLUSIONS

In this multicenter, single-arm study, the combined regimen was associated with clinically relevant improvement and was generally well tolerated in adults with moderate-to-severe MF. These encouraging findings support further evaluation in controlled studies with longer follow-up.

TRIAL REGISTRATION: MR-44-22-009680.