NCT02520986

Brief Summary

In a randomized clinical trial of 114 women undergoing Treatment for condyloma acuminata, two surgical methods, the carbon dioxide laser Ablation and the excision by electrocoagulation, will be compared. The primary outcome of the study is the cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step visual analogue scale (VAS), secondary outcomes are intervention time, operative complications, subjects and users satisfaction, postoperative pain and recurrence of genital warts.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress94%
Dec 2016Dec 2026

First Submitted

Initial submission to the registry

August 4, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

10 years

First QC Date

August 4, 2015

Last Update Submit

August 13, 2025

Conditions

Condylomata Acuminata

Keywords

Sexually transmitted diseaseGenital WartsVenereal Warts

Outcome Measures

Primary Outcomes (1)

  • Cosmetic result

    Cosmetic result judged by the Patient 6 weeks after Treatment using a 11-step visual analogue scale (VAS)

    6 weeks

Secondary Outcomes (8)

  • users satisfaction

    30 minutes

  • Operation time

    20 minutes

  • Postoperative pain

    5 hours

  • Subjects satisfaction

    6 weeks

  • Recurrence of genital warts

    12 months

  • +3 more secondary outcomes

Study Arms (2)

Carbon dioxide Laser ablation

EXPERIMENTAL

Excision of genital warts using a carbon dioxide laser, ie CO2 Laser

Device: Carbon dioxide Laser ablation

Electrocoagulation

ACTIVE COMPARATOR

Excision of genital warts using a superficial electrical coagulation mode, ie spray coagulation

Device: Electrocoagulation

Interventions

Carbon dioxide Laser ablationDEVICE

surgical Instrument to achieve excision of genital warts by a pulsed laser of 15 Watt voltage

Carbon dioxide Laser ablation
ElectrocoagulationDEVICE

surgical Instrument to achieve excision of genital warts by a deep tissue electrocoagulation of 80 Watt voltage

Electrocoagulation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent
  • women with anogenital affection of condyloma acuminata

You may not qualify if:

  • significant language barrier
  • pregnancy
  • unwillingness to participate
  • the use of blood thinner or known coagulation disorder
  • the use of immunosuppressive medicament
  • HIV-Infection
  • malignant diseases
  • local therapy within 8 weeks before Treatment
  • wound healing disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, 44625, Germany

RECRUITING

MeSH Terms

Conditions

Condylomata AcuminataSexually Transmitted Diseases

Interventions

Electrocoagulation

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsSexually Transmitted Diseases, ViralCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsGenital DiseasesUrogenital DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CauteryTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Ziad Hilal, Dr. med.

    Zydolab - Institute of Cytology and Immune Cytochemistry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziad Hilal, Dr. med.

CONTACT

+49231529747z.hilal@zydolab.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Ziad Hilal

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 13, 2015

Study Start

December 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)