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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AGUNCO Obstetrics and Gynecology Centre

ClinicalTrials.gov Identifier:

NCT01571141

First received: April 2, 2012

Last updated: April 18, 2012

Last verified: June 2011

History of Changes

Purpose

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.

Condition	Intervention	Phase
HPV Infection	Device: Monogin	Phase 4

Study Type:

Interventional

Further study details as provided by AGUNCO Obstetrics and Gynecology Centre:

Primary Outcome Measures:

Number of patients with no HPV infection

Arms	Assigned Interventions
Experimental: Monogin	Device: Monogin Gynaecological solution with polyhexamethylene biguanide, pH 4.0
No Intervention: No intervention

Eligibility

Ages Eligible for Study:	30 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571141

Locations

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

Sponsors and Collaborators

AGUNCO Obstetrics and Gynecology Centre

More Information

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. Review.

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. Epub 2010 Sep 8. Review.

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.

Responsible Party:	AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:	NCT01571141 History of Changes
Other Study ID Numbers:	PHMB_HPV
Study First Received:	April 2, 2012
Last Updated:	April 18, 2012
Health Authority:	Italy: Ministry of Health

Keywords provided by AGUNCO Obstetrics and Gynecology Centre:

HPV
polyhexamethylene biguanide
intraepithelial lesions
regression rate

Additional relevant MeSH terms:

Polyhexamethylene biguanide
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2012

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