Exploring the Safety and Compatibility of a Ready-to-Use Vaginal Film Vehicle for Drug Delivery: A Clinical Assessment

Purpose: This study aimed to evaluate the safety profile and clinical acceptance of FemPhylloTM, a novel ready-to-use base for mucoadhesive vaginal films, in the context of personalized medicine. The assessment focused on the vehicle’s compatibility with vaginal mucosa and its influence on vaginal microbiota and pH levels. Methods: A non-comparative, controlled, clinical trial was conducted with healthy female subjects aged 18 to 50. The study involved a 4-week application of the vaginal film, with evaluations including clinical assessments, vaginal pH measurement, and microbiological cultures. Key exclusion criteria included recent infections, current medication use affecting mucosal integrity, and physiological conditions such as pregnancy. Results: The trial comprised 32 participants who completed the study, showing no significant adverse reactions related to the use of FemPhylloTM. Clinical observations confirmed the absence of discomfort, irritation, or other negative symptoms. Vaginal pH levels remained stable throughout the study period, with no significant alterations. Microbiological analysis showed no growth in pathogenic bacteria or fungi. Conclusion: FemPhylloTM demonstrated a high level of safety and was well tolerated without disturbing the vaginal ecosystem. The stability of vaginal pH and the absence of microbial growth confirm its potential as a safe carrier for various pharmaceutical agents. Further studies are recommended to assess long-term impacts.