- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01571141
Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection
Human papillomavirus (HPV) infection is a worldwide problem strictly linked to the development of cervical cancer. Persistence of the infection is one of the main factors responsible for the invasive progression and women diagnosed with intraepithelial squamous lesions are referred for further assessment and surgical treatments which are prone to complications. Despite this, there are several reports on the spontaneous regression of the infection.
In this study the investigators will evaluate the effectiveness of a long term polyhexamethylene biguanide (PHMB)-based local treatment in improve the viral clearance reducing the time exposure to the infection and avoiding the complications associated with the invasive treatments currently available.
Women diagnosed with HPV infection were randomly assigned to receive six months of treatment with a PHMB-based gynaecological solution (Monogin®) or to remain untreated for the same period of time.
The administration of Monogin® has been performed every three days for fifteen days and then every fifteen days for the subsequent six months.
Study Overview
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
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Messina, Italy
- Consultorio Familiare Terme Vigliatore, A.S.P. 5
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- pathologic Pap smear
- positive "high risk" HPV DNA test
- positive colposcopy examination
Exclusion Criteria:
- patients who had undergone wart therapy in the previous six months
- pregnancy
- invasive disease
- immunosuppression
- previous HPV vaccination
Study Plan
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: No intervention
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Experimental: Monogin
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Gynaecological solution with polyhexamethylene biguanide, pH 4.0
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Number of patients with no HPV infection
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Collaborators and Investigators
Publications and helpful links
General Publications
- Zanotti KM, Belinson J. Update on the diagnosis and treatment of human papillomavirus infection. Cleve Clin J Med. 2002 Dec;69(12):948, 951-5, 956 passim. doi: 10.3949/ccjm.69.12.948.
- Hubner NO, Kramer A. Review on the efficacy, safety and clinical applications of polihexanide, a modern wound antiseptic. Skin Pharmacol Physiol. 2010;23 Suppl:17-27. doi: 10.1159/000318264. Epub 2010 Sep 8.
- Marelli G, Papaleo E, Origoni M, Caputo L, Ferrari A. Polyhexamethylene biguanide for treatment of external genital warts: a prospective, double-blind, randomized study. Eur Rev Med Pharmacol Sci. 2005 Nov-Dec;9(6):369-72.
- Gentile A, Gerli S, Di Renzo GC. A new non-invasive approach based on polyhexamethylene biguanide increases the regression rate of HPV infection. BMC Clin Pathol. 2012 Sep 25;12:17. doi: 10.1186/1472-6890-12-17.
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHMB_HPV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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