Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Monogin
|
Device: Monogin
Gynaecological solution with polyhexamethylene biguanide, pH 4.0
|
| No Intervention: No intervention
|
Outcome Measures
Primary Outcome Measures
- Number of patients with no HPV infection []
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Consultorio Familiare Terme Vigliatore, A.S.P. 5 | Messina | Italy |
Sponsors and Collaborators
- AGUNCO Obstetrics and Gynecology Centre
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- PHMB_HPV