Open-Label, Non-Controlled Pilot Study of a New Medical Device Gel for the Treatment of Folliculitis: A Post Market Clinic Follow-Up Assessment

Background: There is growing interest in developing safe and effective treatments for folliculitis. This study aims to assess a recently developed medical device widely used by dermatologists in their daily practice. Methods: This was an open, non-comparative, single-group pilot study including males and females (between ≥ 18 and ≤ 45 years) diagnosed with folliculitis. Exclusion criteria were aesthetic surgery or skin improvement treatments (including filler injections) in the previous six months. The performance outcomes included number of lesions, Total Severity Score (TSS), Treatment Satisfaction Questionnaire, Investigator Global Assessment of Performance (IGAP), and Dermatology Life Quality Index. Safety was ascertained by Adverse Events. Results: Thirteen patients (mean age 30.1 ± 7.72) were included. After eight weeks of treatment, there was a statistically significant difference in the number of lesions (p = 0.005) and TSS (p = 0.002) compared to the baseline values. The patients were very satisfied (76.9%) or moderately satisfied (23.1%) with the treatment. The IGAP and the QoL scale revealed very positive results. Safety was good, with two mild side effects spontaneously resolved. Conclusions: The product's efficacy and safety profile indicate its potential to become a novel instrument for dermatologists in the management of folliculitis.