Silicon dioxide vaginal gel and short-term high-risk human papillomavirus DNA detectability: A randomized controlled trial.

Abstract

Introduction: Intravaginal products, including silicon dioxide-based gels, are marketed to support short-term high-risk human papillomavirus (hrHPV) clearance or loss of detectability, but independent randomized evidence testing these short-term claims against observation is limited. We evaluated whether daily intravaginal silicon dioxide-based gel treatment increases the proportion of women with no detectable cervical hrHPV DNA compared with observation alone.

Material and methods: This prospective, single-center, parallel-group, randomized, open-label controlled trial included women with PCR-confirmed cervical hrHPV infection and no indication for immediate treatment. Participants were randomized 1:1 to 3 months of self-administered daily intravaginal gel treatment or observation alone. The primary outcome was absence of detectable cervical hrHPV DNA by PCR at 3 months. Secondary outcomes during the randomized study period were patient-reported satisfaction and adverse events.

Trial registration: ClinicalTrials.gov, NCT05509413, https://clinicaltrials.gov/study/NCT05509413.

Results: Between November 2022 and January 2025, 242 women were randomized, with 121 allocated to each group. Primary-endpoint data were available for 208 women. At 3 months, hrHPV DNA was not detected in 18/99 women (18%) in the gel treatment group and 23/109 women (21%) in the observation group (absolute risk difference -2.9 percentage points, 95% CI -14 to 8; p = 0.60). A reduced post hoc adjusted sensitivity analysis did not materially change the interpretation of the primary comparison. Patient-reported adverse events were more frequent in the gel treatment group than in the observation group (32/99 [32%] vs. 2/106 [2%]; absolute risk difference 30 percentage points, 95% CI 21 to 40; p < 0.001). Satisfaction scores were high in both groups but lower with gel treatment.

Conclusions: In this randomized trial, 3 months of daily intravaginal silicon dioxide-based gel treatment did not improve short-term loss of detectable cervical hrHPV DNA compared with observation alone. The trial did not reproduce the large short-term virologic benefit suggested by prior product-related studies. The findings do not support routine use of this intervention solely to promote short-term hrHPV non-detectability in women without an indication for immediate treatment, particularly given the higher frequency of local adverse events.