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

NCT07429071 | Recruiting DMC

• 1 other identifier: 16-0302-44
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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:

1. 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. 2.Control group; Women (n=35) will follow the conventional "wait and see" approach.

Conditions

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

Keywords

Womens Health; Cervical Dysplasia; Cervical Intraepithelial Neoplasia (CIN); Human Papillomavirus (HPV); Non-Invasive Treatments

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Histopathologically CIN regression

  at baseline and after 6 months

• Patient compliance and satisfaction measures

  6 months

• Characterizing the Vaginal Microbiome

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Combination Product: Papilocare Vaginal Gel

Control

NO INTERVENTION

Interventions

Papilocare Vaginal Gel COMBINATION_PRODUCT

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).

Intervention

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Aarhus: lead
• Procare Health Iberia S.L.: collaborator

Study Sites (2)

Department of Gynaecology and Obstetrics

Horsens, 8700, Denmark

RECRUITING

Department of Gynaecology and Obstetrics

Randers, Denmark

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Pinar Bor, Professor, MD, Ph.D.

CONTACT

22504767; isipinbo@rm.dk

Vibe M Bertelsen, Post.Doc, MD, Ph.D.

CONTACT

vibebert@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post.doc, MD, Ph.D

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 24, 2026
• Study Start: June 9, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)