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

HPV Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571141
• Other study ID #: PHMB_HPV
• Status: Completed
• Phase: Phase 4
• First received: April 2, 2012
• Last updated: April 18, 2012

Study information

• Verified date: June 2011
• Source: AGUNCO Obstetrics and Gynecology Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 45 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• HPV Infection

Intervention

Device:
• Monogin
Gynaecological solution with polyhexamethylene biguanide, pH 4.0

Locations

Country	Name	City	State
Italy	Consultorio Familiare Terme Vigliatore, A.S.P. 5	Messina

Sponsors (1)

Lead Sponsor	Collaborator
AGUNCO Obstetrics and Gynecology Centre

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Hübner 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with no HPV infection