The goal of this clinical trial is to evaluate whether a Coriolus versicolor-based vaginal gel promotes regression of CIN1/CIN2 and facilitates HPV clearance in women aged 30-50 years diagnosed with CIN1 or CIN2 and HPV. In addition, the study will assess patient satisfaction, treatment compliance and characterize the vaginal microbiome.
The primary outcomes therefore is:
* the regression of the cervical dysplasia from baseline to the follow-up (6 months), which will be assessed through either liquid-based cytology and/or histopathology (biopsy). * HPV 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.
Positive HPV test
Underwent colposcopy with subsequent histopathological findings of CIN1 or CIN2
Allocated to a 'watchful waiting' management strategy.
Understand Danish, written and orally.
Pregnancy or breastfeeding
Unexplained bleeding
Immunosuppressive/modulatory diseases or treatment
Cancer or cancer related diseases
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).
Histopathological CIN regression
From cervical biopsies from the already planned colposcopy examinations.
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.
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.
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University of Aarhus
Lead sponsor
Procare Health Iberia S.L.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
