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

NCT07429071 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 16-0302-44
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:
• 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).
• 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 (2)

• Histopathological CIN regression

  From cervical biopsies from the already planned colposcopy examinations.

  6 months

• 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 (2)

• 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:

• 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.

You may not qualify if:

• Pregnancy or breastfeeding
• Unexplained bleeding
• Immunosuppressive/modulatory diseases or treatment
• Cancer or cancer related diseases

Sponsors & Collaborators

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

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: early phase 1
• 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: March 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share