Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection
Primary Purpose
HPV Infection
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Monogin
Sponsored by
About this trial
This is an interventional trial for HPV Infection focused on measuring HPV, polyhexamethylene biguanide, intraepithelial lesions, regression rate
Eligibility 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
Sites / Locations
- Consultorio Familiare Terme Vigliatore, A.S.P. 5
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Monogin
No intervention
Arm Description
Outcomes
Primary Outcome Measures
Number of patients with no HPV infection
Secondary Outcome Measures
Full Information
NCT ID
NCT01571141
First Posted
April 2, 2012
Last Updated
April 18, 2012
Sponsor
AGUNCO Obstetrics and Gynecology Centre
1. Study Identification
Unique Protocol Identification Number
NCT01571141
Brief Title
Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGUNCO Obstetrics and Gynecology Centre
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infection
Keywords
HPV, polyhexamethylene biguanide, intraepithelial lesions, regression rate
7. Study Design
Study Phase
Phase 4
8. Arms, Groups, and Interventions
Arm Title
Monogin
Arm Type
Experimental
Arm Title
No intervention
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Monogin
Intervention Description
Gynaecological solution with polyhexamethylene biguanide, pH 4.0
Primary Outcome Measure Information:
Title
Number of patients with no HPV infection
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Consultorio Familiare Terme Vigliatore, A.S.P. 5
City
Messina
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
12546268
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. doi: 10.3949/ccjm.69.12.948.
Results Reference
background
PubMed Identifier
20829658
Citation
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.
Results Reference
background
PubMed Identifier
16479742
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.
Results Reference
background
PubMed Identifier
23009652
Citation
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.
Results Reference
derived
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Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection
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