To evaluate the efficacy of PapilocareR -a Coriolus versicolor-based vaginal gel- to repair cervical mucosa in women with HPV-related cytology alterations and consistent colposcopy image.
A randomized, open-label, parallel-group, controlled clinical trial. Currently recruiting 96 positive-HPV women age 30 to 65 with pap result of ASC-US, LSIL or AG-US and concordant colposcopy image, randomized into 3 groups: A) PapilocareR 1 cannula/day for 1 month + 1 cannula/alternate days for 5 months; B) PapilocareR 1 cannula/day for 3 months + 1 cannula/alternate days for 3 months; C) no treatment as usual practice. Interim analysis of secondary endpoints - changes in epithelialization of the cervix evaluated by standard colposcopy and in perceived stress evaluated by PSS14 - are presented. PapilocareR arms (A+B) were combined for this evaluation.
Data from 47 patients at 3 months and 29 patients at 6 months are available. 20.7% and 47.5% of patients in PapilocareR group improved the cervix epithelialization at month 3 and 6 respectively vs 22.2% and 16.7 in control group (p=ns). A trend to stress reduction vs basal was observed in the treatment group at month 3 (-0.9 points) and was significant at month 6 (-2.9; p=0.045, Student´s t-test). Patients in control group showed a trend to stress increase at month 3 and 6 (+0.5 and +4.7; p=ns). There were not significant differences between treatment groups.
In these interim analysis results, PapilocareR shows a positive trend in cervix epithelialization and a significant stress reduction; these findings need to be confirmed upon study completion.