Randomized, prospective trial to evaluate the effects of the intravaginal gel DeflaGyn^® on the regression rate of HPV high-risk positive strains and the cytological p16/Ki67 marker in women with cytological findings according to Bethesda (ASC-US, LSIL, ASC-H, and HSIL)

Objective The objective of the study was to determine the influence of a medical device containing silicon dioxide, citric acid and selenite in women with cytological findings according to Bethesda on the clearance of HPV high-risk strains and the changes of cytological tests for p16/Ki67 after a 3-months treatment as well as after a further 3-months follow-up.

Patients and methods Two-hundred and six teen (216) patients were randomized in an open, prospective study. One hundred and eight (108) received the medical device, and 108 conformed a placebo group. Before and after the treatment, the HPV status and the p16/Ki67 status were determined in all 216 patients.

Results After the 3-month treatment a clearance of High-risk positive HPV patients from 94 to 43 (reduction from 89.7 % to 39.8 %) was observed in the active arm whereas in the control arm 85 patients were positive at the screening stage and 90 after 3 months (elevation from 78.7 % to 83.3 %). Regarding the p16/Ki67 test at screening, 77 patients were positive in the active arm and 99 in the control arm. After 3 months 13 were positive in the active arm and 81 in the control arm. Three months after finishing treatment, six patients were positive in the active arm, whereas 82 patients remained positive in the control arm.

Conclusion DeflaGyn^® Vaginal Gel has shown to be highly effective in the reduction of HPV high risk and p16/Ki67 positive women thus offering a new active management in the prevention of cervical cancer.

Publication History

Article published online:
07 October 2020