Pilot Clinical Evaluation of a Hyaluronic Acid– and Hydrogen Peroxide–Based Gel in the Management of Folliculitis: An Open-Label, Post-Marketing Study

Background: Folliculitis is a common inflammatory condition for which non-antibiotic topical options remain limited. This pilot study evaluated the performance and safety of a medical device gel containing hyaluronic acid and hydrogen peroxide, already in use in dermatologic practice. The study generated preliminary efficacy outcomes and assessed the viability for a future comparative trial on folliculitis.Methods: This open-label, non-comparative, post-marketing clinical follow-up study enrolled adults (aged 18–45 years) diagnosed with folliculitis. Patients applied the gel at home for eight weeks following the device’s instructions for use. Efficacy was assessed by the number of lesions, Total Severity Score (TSS), Investigator Global Assessment of Performance (IGAP), patient satisfaction, and Dermatology Life Quality Index (DLQI). Safety was evaluated by recording adverse events (AEs).Results: Thirteen patients (mean age 30.1 ± 7.72) were included. The duration of enrollment and its rate met the assumptions for carrying out the future comparative trial. The mean number of lesions decreased three-fold from baseline to week 8 (p = 0.005), while TSS improved by 66.6% (p = 0.002). All participants reported high or very high treatment satisfaction. The mean IGAP at week 8 was 1.39 ± 0.65, and DLQI scores indicated a marked improvement in quality of life. Two mild, transient site effects were recorded.Conclusions: This pilot study confirmed favorable safety and performance outcomes for the hyaluronic acid/hydrogen peroxide gel in patients with folliculitis. The findings support its use in daily dermatologic practice and provide feasibility data for a future randomized comparative trial.