Pilot study of topical management of folliculitis: clinical outcomes and safety in routine practice.

Abstract

Folliculitis is a common inflammatory skin condition for which non-antibiotic topical management options remain limited. This pilot study reports clinical performance, safety, and feasibility data from the use of a medical device gel containing hyaluronic acid (HA) and hydrogen peroxide used in dermatologic practice. Adults aged 18-45 years with a diagnosis of folliculitis applied the gel for 8 weeks according to the instructions for use. Clinical outcomes included lesion count, Total Severity Score (TSS), Investigator Global Assessment of Performance (IGAP), patient satisfaction, and Dermatology Life Quality Index (DLQI). Safety was assessed through adverse event (AE) reporting. Thirteen patients (mean age 30.1±7.7 years) were included. Enrollment rate and study conduct supported the feasibility of a future comparative trial. From baseline to week 8, mean lesion count showed a three-fold reduction, accompanied by a 66.6% improvement in TSS. Investigator- and patient-reported assessments indicated consistent clinical improvement with a positive impact on quality of life. Two mild and transient local effects were reported. Overall, these preliminary observations suggest favorable safety and performance of the gel in routine folliculitis management and support further controlled studies.