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

Condition(s) studied

Investigational drug(s) / intervention(s)

Papilocare 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).

Study 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

Primary outcome measure(s)

• Type specific HPV clearance — 6 months
  Additional HPV self-samples will be collected by the paticipants before initiation of the vaginal gel and after 6 months of treatment.

Trial sites (2)

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