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.
Aged 30-50 years
A positive hrHPV test with histopathological confirmed CIN1 or CIN2
Managed under a 'watchful waiting' strategy as part of standard management
Understand Danish, both written and orally
Pregnancy or breastfeeding
Unexplained vaginal bleeding
Immunosuppressive or immunomodulatory conditions or treatment
Diabetes mellitus
Parallel
Papilocare Vaginal Gel
Combination productWomen (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).
Type specific HPV clearance
Additional HPV self-samples will be collected by the paticipants before initiation of the vaginal gel and after 6 months of treatment.
Histopathologically CIN regression
CIN regression evaluated by cervical biopsies after 6 months
Patient compliance and satisfaction measures
Compliance and treatment satisfaction will be assessed using patient-reported questionnaires and outcomes is measured using a 5-point Likert scale (minimum value = 1, maximum value = 5), where higher scores indicate a better outcome.
Characterizing the Vaginal Microbiome
A self-collected vaginal swab will be obtained before treatment initiation and again after six months of treatment.
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Procare Health Iberia S.L.
Collaborator
