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

Summary

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.

Eligibility

Inclusion criteria:

* 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

Exclusion criteria:

* Pregnancy or breastfeeding
* Unexplained vaginal bleeding
* Immunosuppressive or immunomodulatory conditions or treatment
* Diabetes mellitus
* Prior hysterectomy
* Any ongoing cancer diagnosis, prior CIN3 or a history of malignancy in the genital/anal region within 5 years (excl. non-melanoma skin cancer)

Conditions6

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