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DEFLAGYN® Vaginal Gel and Spontaneous Remission and Regression of Unclear Cervical Smears and HPV High-risk Infections

NCT05509413 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2025-11-18

No results posted yet for this study

Summary

Human papillomaviruses (HPV) are the most common sexually transmitted pathogens worldwide and in most cases are causally associated with the development of cervical cancer, one of the most common cancers in women and one of the leading causes of death in women worldwide. Precancerous lesions (dysplasias) or the presence of a high-risk HPV subtype are detected by a screening smear test performed by a gynecologist. If precancerous lesions are detected, conization (= surgical removal of a cone of tissue from the cervix) is the method of choice for removing the diseased tissue. However, if the degree of dysplasia is correspondingly low or the smear is unclear, then the guideline-compliant non-surgical treatment provides for a wait-and-see approach with PAP and HPV smear control after 6-8 months.

This "wait-and-see" approach can be complemented by local therapy with an immunostimulant. For this purpose, DEFLAGYN® (a vaginal gel containing silica and citric acid) and Aldara® (imiquimod, a Toll-Like Re-ceptor 7 antagonist) are available. However, while the latter is not approved for the treatment of cervical dysplasia or HPV infection, DEFLAGYN® has CE marking and approval as a medical device for treatment in a number of indications, such as unclear cervical smears, HPV-induced cervical lesions, p16/Ki-67-positive cervical lesions or cervical erosions.

However, available studies on the efficacy of DEFLAGYN are limited. For example, there is only one prospective randomized trial (Major et al, 2021, Arch. Gynecol. Obstet. 303:501-511), which included 216 women with histologically confirmed CIN 1/2. A 3-month intravaginal application of DEFLAGYN® resulted in regression of CIN 1/2 in 72% versus 25% in the control arm (no intervention). Side effects of therapy with DEFLAGYN® were not observed in this study.

Due to the frequency of CIN and HPV infections in the female population and due to the high medical relevance of a conservative method of treating this disease, further methodologically high-quality studies on the efficacy of DEFLAGYN® should be performed.

Conditions

Interventions

DEVICE

DEFLAGYN vaginal gel

DEFLAGYN is a vaginal gel, classified as a medical device, containing silica and citric acid, which binds pathogens, inhibits their spread and exerts an antioxidant effect. It is applied intravaginally (through an applicator) and used for 3 months.

Sponsors & Collaborators

  • Ruhr University of Bochum

    lead OTHER

Principal Investigators

  • Clemens B Tempfer, MD, MBA · Ruhr-Universität Bochum, Marien Hospital Herne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-08
Primary Completion
2025-05-23
Completion
2025-08-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05509413 on ClinicalTrials.gov