Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Cervical Intraepithelial Neoplasia (CIN) | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Human Papilloma Virus (HPV) | — | UNRESOLVED | — |
| Non-invasive Treatment | — | UNRESOLVED | — |
| Womens Health | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Papilocare Vaginal Gel | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- interventionNames
- Combination Product: Papilocare Vaginal Gel
- type
- NO_INTERVENTION
- label
- Control
Primary outcomes (1)
- measure
- Type specific HPV clearance
- timeFrame
- 6 months
- description
- Additional HPV self-samples will be collected by the paticipants before initiation of the vaginal gel and after 6 months of treatment.
Secondary outcomes (3)
- measure
- Histopathologically CIN regression
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available