Antisepsis Regimen After Surgical Treatment of HPV Infected LesionsPhase 4NCT01740245

Antisepsis Regimen in the Surgical Treatment of Human Papilloma Virus Generated Cervical Lesions: Polyhexamethylene Biguanide Versus Chlorhexidine

A Phase 4 study testing Chlorhexidine vaginal suppositories and Polyhexamethylene biguanide vaginal suppositories in people with Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 40 years, women only
Conditions the study is for: Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions
What is being tested?: Chlorhexidine vaginal suppositories and Polyhexamethylene biguanide vaginal suppositories
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: Not given
Where: 1 siteItaly
Study dates: Start not givento not given
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

pregnancy

Trial locations and contacts

1 site in 1 country.

Italy1 site

AGUNCO
Rome, 00132

Other trials in Italy

About this study

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.

Conditions: Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions
Being tested: Chlorhexidine vaginal suppositories, Polyhexamethylene biguanide vaginal suppositories
Keywords: Laser therapy, Cervical lesions, Polyhexamethylene biguanide, Chlorhexidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chlorhexidine vaginal suppositoriesDevice
Polyhexamethylene biguanide vaginal suppositoriesDevice

Study groups in NCT01740245
Study group	Role	What they receive
Chlorhexidine	Active comparator	Not described Receives: Device: Chlorhexidine vaginal suppositories
Polyhexamethylene biguanide	Experimental	Not described Receives: Device: Polyhexamethylene biguanide vaginal suppositories

What is being measured

The primary outcome is the main question the study is designed to answer.

Bacterial vaginosis
Diagnosis of eventual bacterial infection is performed according to Amsel's criteria
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At weekly intervals by the day of laser treatment
Bacterial vaginosis
Diagnosis is performed according to the Amsel's criteria
Measured: After six weeks by the day of laser treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

First posted4 Dec 2012 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Antisepsis Regimen After Surgical Treatment of HPV Infected LesionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4

IDs, dates and publications

ClinicalTrials.gov ID: NCT01740245
Sponsor's protocol ID: CHX-PHMB
Status last verified: Jun 2012
First submitted: 28 Nov 2012
Last updated: 4 Dec 2012
Results posted: No

Publications

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.
PubMed 12353208
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.
PubMed 20829657
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.
PubMed 20551215
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.
PubMed 18364400

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Antisepsis Regimen in the Surgical Treatment of Human Papilloma Virus Generated Cervical Lesions: Polyhexamethylene Biguanide Versus Chlorhexidine
ClinicalTrials.gov ID: NCT01740245
Acronym / sponsor ID: CHX-PHMB
Conditions: Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions
Keywords: Laser therapy, Cervical lesions, Polyhexamethylene biguanide, Chlorhexidine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Lead sponsor: AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
First posted: 4 Dec 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Number of arms: 2

Arm	Type	Receives
Chlorhexidine	Active comparator	Device: Chlorhexidine vaginal suppositories
Polyhexamethylene biguanide	Experimental	Device: Polyhexamethylene biguanide vaginal suppositories

Who may qualify

Ages: 20 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Chlorhexidine vaginal suppositories	Device	Chlorhexidine
Polyhexamethylene biguanide vaginal suppositories	Device	Polyhexamethylene biguanide

Primary outcome

Bacterial vaginosis
Time frame: After three weeks by the day of the laser treatment
Diagnosis of eventual bacterial infection is performed according to Amsel's criteria
Change from baseline bleeding at 6 weeks
Time frame: At weekly intervals by the day of laser treatment
Visual scoring was assessed depending on the grade of the defect (from 1 to 3)
Change from baseline healing process at 6 weeks
Time frame: At weekly intervals by the day of laser treatment
Visual scoring for healing is assessed depending on the grade of the defect (from 1 to 3)
Change from baseline irritation status at 6 weeks
Time frame: At weekly intervals by the day of laser treatment
Visual scoring for irritation is assessed depending on the grade of the defect (from 1 to 3)
Bacterial vaginosis
Time frame: After six weeks by the day of laser treatment
Diagnosis is performed according to the Amsel's criteria

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
Background: PubMed 12353208Wiley 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.
Background: PubMed 20829657Kaehn K. Polihexanide: a safe and highly effective biocide. Skin Pharmacol Physiol. 2010;23 Suppl:7-16. doi: 10.1159/000318237. Epub 2010 Sep 8.
Background: PubMed 20551215Koburger 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.
Background: PubMed 18364400Muller 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bacterial vaginosis (time frame: After three weeks by the day of the laser treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01740245, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.