Effectiveness of a Vaginal Gel on CIN1/2 Regression and HPV Clearance.

The goal of this clinical trial is to evaluate whether a Coriolus versicolor-based vaginal gel facilitates HPV clearance in women aged 30-50 years diagnosed with HPV and CIN1 or CIN2. In addition, the study will investigate whether the gel promotes regression of CIN1/CIN2, assessment of patient satisfaction, treatment compliance and characterize the vaginal microbiome. The primary outcomes therefore is: • hrHPV clearance from baseline to follow-up (6 months) In this randomized controlled study, eligible participants will be randomized 1:1 into two groups: 1. Intervention group: Women (n=35) will apply a CV-based vaginal gel (Papilocare®) daily for 21 days for 3 months. Afterward, the gel should be used every other day for an additional 3 months. Every month includes a 7-day break due to menstruation (28 days cycle). 2. Control group; Women (n=35) will follow the conventional "wait and see" approach.

NCT Number	NCT07429071
Lead Sponsor	University of Aarhus Collaborators: Procare Health Iberia S.L.
Conditions	Womens Health, Cervical Dysplasia, Cervical Intraepithelial Neoplasia (CIN), Non-invasive Treatment, Human Papilloma Virus (HPV)
Enrollment	70 participants
Start Date	2026-06-09
Primary Completion	2026-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-03