CLINICAL TRIAL

Main objective: to compare clinical and molecular evolution of oro-pharyngeal candidiasis after 24 hours and 15 days of VG-01 therapy using a toothpaste as a vehicle. The clinical trial was uni-center, open label, single-arm and approved by institutional Ethical Research Committee.

Sample size: this clinical trial was offered to 50 patients to obtain 21 patients acceptable for final analysis.

Procedure: patients clinically diagnosed with oro-pharyngeal candidiasis were offered to join the clinical trial and started to be treated three times-a-day. In 15 day’s schedule, with a VG-01 containing toothpaste and after a collection of a saliva sample and oro-pharyngeal picture on day 0. Only patients matching clinical suspicion of oro-pharyngeal candidiasis and Candida spp. evidence by RT-PCR on day 0 saliva sample were included for final analysis. Additional saliva samples and clinical assessments were obtained 24 hours after first dose of VG-01 and on day 15. Each patient was his/her own control for clinical and molecular responses. So that, quantification of saliva Candida spp. nucleic acids evidence by RT-PCR on day 0 was compared with sample on day 1 and on day 15. Similarly, we made a comparison between clinical assessments performed on day 0 with those performed on day 1 and 15.

Results: Total of 50 patients were asked to join the trial. Finally, 23 patients were recruited for the trial. 71% of them, showed C. albicans infection, meanwhile the other 29% showed C. non-albicans infection. The treatment with VG-01 toothpaste reduced de quantity of DNA and UFCs during the 15 days of treatment in both types of infection. After 24 hours and 15 days of treatment, 71 and 52% of patients improved their health, respectively. It is important to highlight that the all the patients were immune-depressed and even in these conditions, VG-01 worked.

Conclusion:

  • VG-01 is active against Candida spp. and Cryptococcus neoformans.
  • First clinical trial evidenced clinical responses higher than 80% and molecular responses higher than 50% of patients. Besides, 82% of patients say they would use this toothpaste outside the study.

VG-01 results have been innovative and novel enough to be granted with a full patent in the EU, USA, Canada and others.