Evaluación de la Eficacia de la combinación de GLIZIGEN® solución Oral 1/día y Gel Vaginal 1/Noche Durante 2 Meses en Pacientes Con Neoplasia Intraepitelial Cervical de Grado 1 (LSIL/CIN-1) Causada Por el Virus Del Papiloma Humano de Alto Riesgo (VPH-AR).
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Catalysis SL
- Enrollment
- 120
- Locations
- 8
- Primary Endpoint
- Rate of resolution of cervical intraepithelial neoplasia grade 1 (CIN-1) caused by High Risk Human Papillomavirus (HR-HPV).
Study Overview
Brief Summary
HPV infection can lead to cancer, especially when precancerous lesions have developed and high-risk HPV is present.
Glizigen is an oral and intravaginal treatment based on activated glycyrrhizinic acid that has shown potential benefit in patients with HPV.
In order to improve the existing evidence, the present study consists of a randomized, double-blind, placebo-compared clinical trial to evaluate the efficacy of combined treatment with Glizigen Oral Solution and Glizigen Vaginal Gel for the resolution of biopsy-confirmed grade 1 cervical intraepithelial neoplasia (CIN-1) in patients with high-risk HPV.
Detailed Description
Human Papillomaviruses are double-stranded DNA viruses characterised by their lack of a lipid envelope. To date, more than 100 different types of HPV have been identified. They can be divided into cutaneous or mucosal depending on the tissues they usually infect 1. In parallel, HPVs can be classified as low-risk (HR-HPV) or high-risk (HR-HPV) viruses, depending on the risk of developing cancer due to their persistence of infection 2. Fifteen HPV types are considered high-risk (16, 18, 31, 33, 35, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73 and 82) while three other types are classified as probable high-risk (26, 53 and 66).
HPV infection occurs through direct contact with the skin or mucous membranes of an infected person, who may or may not have visible lesions. In the case of genital infection, vaginal or anal intercourse is the main route of transmission. HPV is very common, and it is estimated that, in the United States, approximately 80% of women will have acquired an infection by the age of 50.
Most HPV infections do not cause symptoms or disease and disappear 12-24 months after infection. The small proportion of these infections that persist result in precancerous lesions that may progress to cancer. HPV infection is associated with virtually 100% of cervical cancer cases and with a high rate of anogenital and oropharyngeal cancers.
According to the World Health Organisation, the approach to cervical cancer prevention consists of primary prevention through HPV vaccination to prevent HPV infection, and secondary prevention through screening programmes to achieve early detection of HPV infection. Screening programmes differ from country to country, but are mainly based on determination of the presence of the virus by viral DNA testing and determination of intraepithelial lesions by cytology (Pap smear). A positive HPV DNA test implies the presence of the virus in the sample, while positive cytology implies an alteration or lesion in the tissue.
The morphology of squamous intraepithelial lesions caused by HPV in the lower anogenital tract is identical in all locations and in both sexes. The LAST Terminology classifies HPV-associated histological squamous intraepithelial lesions into two grades, low-grade lesions (LSIL) and high-grade lesions (HSIL). The term LSIL also includes cervical intraepithelial neoplasia grade 1 (CIN1) of the Richart classification, adopted by WHO in 2004.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women between 30 and 65 years of age.
- •Diagnosed with infection with at least one high-risk HPV strain (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 and 82) by PCR test and positive cytology with confirmation of LSIL/CIN-1 by colposcopy and biopsy.
- •Adequate cultural level and understanding of the clinical study.
- •Agree to participate voluntarily in the study and give written informed consent.
Exclusion Criteria
- •Failure to meet any of the inclusion criteria.
- •Patient receiving any other product aimed at favouring the resolution of HPV infection.
- •Women with polymenorrhoea or frequent bleeding that makes vaginal administration of the preparation impossible.
- •Patient with immunosuppressive treatment or with other infectious processes in the genitals (e.g. herpes, candida, etc.).
- •Pregnant patients.
- •Participation in a concomitant trial that conflicts with this study.
- •Women with HIV infection.
- •Patients allergic to any component of the investigational product.
- •Patients who have been vaccinated against HPV before or after the start of the study are eligible to participate in the study, and this should be correctly reflected in the Data Collection Notebook.
Outcomes
Primary Outcomes
Rate of resolution of cervical intraepithelial neoplasia grade 1 (CIN-1) caused by High Risk Human Papillomavirus (HR-HPV).
Time Frame: 6 months
To assess whether nutritional supplementation with Glizigen® oral solution in combination with topical intravaginal use of Glizigen® vaginal gel promotes resolution of grade 1 cervical intraepithelial neoplasia (CIN-1) caused by High-Risk Human Papillomavirus (HR-HPV) compared to placebo after two months of treatment and 4 months after the end of treatment. It will be measured by biopsy.
Secondary Outcomes
- Antiviral effectiveness of glizigen against high-risk HPV infection.(2 and 6 months)
- Antiviral effectiveness of glizigen against multi high-risk HPV infection.(2 and 6 months)
- Grade of safety control(2 and 6 months)
- To Assess patient Tolerance of the study product.(2 and 6 months)
- To Assess patient acceptance of the study product.(2 and 6 months)
- To Assess patient adherence of the study product.(2 and 6 months)
- To Assess adherence to treatment(2 and 6 months)
- Control of progression of Cervical intraepithelial neoplasia from CIN-1 to HSIL/CIN-2/3.(2 and 6 months)