NCT01740245

Brief Summary

Treatments for the macroscopic or pathologic lesions caused by HPV infection can be classified as topical, surgical, destructive, or immunomodulatory. Post surgical treatments generally consist of analgesic, anti-inflammatory and topical antimicrobial agents to reduce the risk of local infections. The aim of this study is to compare the efficacy and safety of polyhexamethylene biguanide-based vaginal suppositories to a similar chlorhexidine-based treatment, in the post recovery regimen after surgical treatment of cervical lesions. Women who underwent to CO2 laser therapy for cervical lesions are randomly assigned to receive 10 days of antiseptic treatment with chlorhexidine digluconate vaginal suppositories, or polyhexamethylene biguanide vaginal suppositories (Monogin® / BiguanelleTM vaginal suppositories, Lo.Li.Pharma, Italy). A weekly follow-up check was performed for 6 weeks.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
Last Updated

December 4, 2012

Status Verified

June 1, 2012

First QC Date

November 28, 2012

Last Update Submit

November 30, 2012

Conditions

Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions

Keywords

Laser therapyCervical lesionsPolyhexamethylene biguanideChlorhexidine

Outcome Measures

Primary Outcomes (5)

  • Bacterial vaginosis

    Diagnosis of eventual bacterial infection is performed according to Amsel's criteria

    After three weeks by the day of the laser treatment

  • Change from baseline bleeding at 6 weeks

    Visual scoring was assessed depending on the grade of the defect (from 1 to 3)

    At weekly intervals by the day of laser treatment

  • Change from baseline healing process at 6 weeks

    Visual scoring for healing is assessed depending on the grade of the defect (from 1 to 3)

    At weekly intervals by the day of laser treatment

  • Change from baseline irritation status at 6 weeks

    Visual scoring for irritation is assessed depending on the grade of the defect (from 1 to 3)

    At weekly intervals by the day of laser treatment

  • Bacterial vaginosis

    Diagnosis is performed according to the Amsel's criteria

    After six weeks by the day of laser treatment

Study Arms (2)

Chlorhexidine

ACTIVE COMPARATOR
Device: Chlorhexidine vaginal suppositories

Polyhexamethylene biguanide

EXPERIMENTAL
Device: Polyhexamethylene biguanide vaginal suppositories

Interventions

Chlorhexidine vaginal suppositoriesDEVICE
Chlorhexidine
Polyhexamethylene biguanide vaginal suppositoriesDEVICE
Polyhexamethylene biguanide

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • positive colposcopy examination
  • positive Papanicolaou smear
  • pathological biopsy
  • physical ablation by CO2 laser therapy for a number of lesions included between 3 and 5

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AGUNCO

Rome, 00132, Italy

Location

Related Publications (4)

  • Wiley DJ, Douglas J, Beutner K, Cox T, Fife K, Moscicki AB, Fukumoto L. External genital warts: diagnosis, treatment, and prevention. Clin Infect Dis. 2002 Oct 15;35(Suppl 2):S210-24. doi: 10.1086/342109.

    PMID: 12353208BACKGROUND

  • Kaehn K. Polihexanide: a safe and highly effective biocide. Skin Pharmacol Physiol. 2010;23 Suppl:7-16. doi: 10.1159/000318237. Epub 2010 Sep 8.

    PMID: 20829657BACKGROUND

  • Koburger T, Hubner NO, Braun M, Siebert J, Kramer A. Standardized comparison of antiseptic efficacy of triclosan, PVP-iodine, octenidine dihydrochloride, polyhexanide and chlorhexidine digluconate. J Antimicrob Chemother. 2010 Aug;65(8):1712-9. doi: 10.1093/jac/dkq212. Epub 2010 Jun 15.

    PMID: 20551215BACKGROUND

  • Muller G, Kramer A. Biocompatibility index of antiseptic agents by parallel assessment of antimicrobial activity and cellular cytotoxicity. J Antimicrob Chemother. 2008 Jun;61(6):1281-7. doi: 10.1093/jac/dkn125. Epub 2008 Mar 25.

    PMID: 18364400BACKGROUND

Study Design

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

Study Record Dates

First Submitted

November 28, 2012

First Posted

December 4, 2012

Last Updated

December 4, 2012

Record last verified: 2012-06

Locations

IT(1)