A clinical trial of Papilocare vaginal gel has reported promising findings on whether its effects continue after
treatment ends.

The Papilocan clinical trial (NCT04210336) was a randomised, double-blind study sponsored by the product’s manufacturer. Participants either received Papilocare for six months (the Papilocare group), or a placebo with no active ingredient (the control group). The Papilocare group used the enhanced regimen:

• 1 tube of Papilocare vaginal gel every day for three months with a pause during menstruation or one week for those who did not have periods
• 1 tube every other day for the subsequent three months with a pause during menstruation or one week for those who did not have periods

Average age of the study participants was 41. 84% of patients had so called high risk HPV strains, including 30% with HPV 16 or 18. 25% of the participants had been vaccinated against HPV, 10% with the first generation and 15% with the second generation (vaccines for 9 strains).

Six months after treatment ended, participants were invited back for a cervical smear and colposcopy (this was 12 - months after treatment started). 98 patients (48 in the Papilocare Group and 50 in the control group) were evaluated. At this visit, 80% of participants in the Papilocare group tested negative for HPV, compared with 45% in the control group. With p=0.037, the finding was statistically significant.

The findings are consistent with 12-month data from the Paloma 2 study and add to the evidence about how long the effects of Papilocare may last after treatment.