Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection

NCT01571141 | Completed Phase 4

• 1 other identifier: PHMB_HPV
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HPV Infection

Keywords

HPV; polyhexamethylene biguanide; intraepithelial lesions; regression rate

Outcome Measures

Primary Outcomes (1)

• Number of patients with no HPV infection

Study Arms (2)

Monogin

EXPERIMENTAL

Device: Monogin

No intervention

NO INTERVENTION

Interventions

Monogin DEVICE

Gynaecological solution with polyhexamethylene biguanide, pH 4.0

Monogin

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pathologic Pap smear
• positive "high risk" HPV DNA test
• positive colposcopy examination

You may not qualify if:

• patients who had undergone wart therapy in the previous six months
• pregnancy
• invasive disease
• immunosuppression
• previous HPV vaccination

Sponsors & Collaborators

• AGUNCO Obstetrics and Gynecology Centre: lead

Study Sites (1)

Consultorio Familiare Terme Vigliatore, A.S.P. 5

Messina, Italy

Location

Related Publications (4)

• 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.

  PMID: 12546268 BACKGROUND

• 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.

  PMID: 20829658 BACKGROUND

• 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.

  PMID: 16479742 BACKGROUND

• 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.

  PMID: 23009652 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 5, 2012
• Last Updated: April 19, 2012

Record last verified: 2011-06

Locations

IT (1)