RecruitingNot ApplicableNCT07429071

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

Effectiveness of Coriolus Versicolor-based Vaginal Gel on HPV Clearance and Regression of Cervical Intraepithelial Neoplasia: a Multicenter Randomized Controlled Trial

Sponsor

University of Aarhus

Enrollment

70 participants

Start Date

Jun 9, 2026

Study Type

INTERVENTIONAL

Conditions

Cervical Dysplasia Human Papilloma Virus (HPV)Cervical Intraepithelial Neoplasia (CIN)Womens Health Non-invasive Treatment

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

Sex: FEMALEMin Age: 30 YearsMax Age: 50 Years

Inclusion Criteria4

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 Criteria6

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)

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Interventions

COMBINATION_PRODUCTPapilocare Vaginal Gel

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).