NCT00189293

Brief Summary

The purpose of this study is to compare the recurrence rate following total clearance of external genital warts (EGWs) when clearance has been obtained by imiquimod (3 applications per week for 4 weeks) followed by ablative therapy (laser or electrocautery therapy) with that from just ablative therapy treatment alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2005

Typical duration for phase_4

Geographic Reach
1 country

12 active sites

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

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 7, 2022

Status Verified

September 1, 2008

Enrollment Period

2.5 years

First QC Date

September 12, 2005

Last Update Submit

February 4, 2022

Conditions

Genital Warts

Keywords

External Ano-Genital WartsAblative TherapyAldara

Outcome Measures

Primary Outcomes (1)

  • recuurence rate 24 weeks after ablative therapy

    24 weeks

Secondary Outcomes (7)

  • Time to recurrence

  • Recurrence rate at 4 and 12 weeks post ablation

    4 and 12 weeks

  • Reduction of EGW area

    4 and 12 weeks

  • Healing and cosmetic outcome

    4, 12 and 24 weeks

  • Local and general tolerability

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Imiquimod 5% cream

Drug: Imiquimod

2

OTHER

vehicle cream

Other: vehicle cream

Interventions

ImiquimodDRUG

Imiquimod 5% cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s)

1
vehicle creamOTHER

vehicle cream three times per week for 4 weeks (1 sachet) 1 or 2 sachet(s)

2

Eligibility Criteria

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

You may qualify if:

  • Subjects with at least 1 visible genital or perianal wart
  • Total wart area 1 to 40 square centimeters.

You may not qualify if:

  • Pregnant or lactating women
  • Known other sexually transmitted disease
  • Evidence of a clinically significant immunodeficiency
  • Evidence of unstable cardiovascular, pulmonary, hematological, hepatic, renal, endocrine, collagen vascular, neurological or gastrointestinal abnormality or disease.
  • Treatment within the 4 weeks prior to the Randomization Visit with any of the following systemic or topical treatments: interferons, interferon inducers, immunomodulators, immunosuppressive drugs, antiviral drugs (except for systemic acyclovir, valacyclovir and famciclovir), cytotoxic drugs, investigational drugs, or any drugs known to have major organ toxicity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Clinica Ostetrica e Ginecologica Università Politecnica delle Marche

Ancona, 60123, Italy

Location

Struttura Complessa di Ostetricia e Ginecologia Ospedale Cardinal Massaia

Asti, 14100, Italy

Location

Unità Operativa di Ginecologia Oncologica, RCCS Ospedale Oncologico

Bari, 70100, Italy

Location

Servizio Autonomo di Diagnosi Precoce dei Tumori Ginecologici Ospedale Vittorio Emanuele

Catania, 95124, Italy

Location

Clinica Ostetrica Ginecologica, Ospedale Careggi

Florence, 50134, Italy

Location

Struttura Complessa Oncologia Chirurgica C Istituto Scientifico dei Tumori IST

Genova, 16132, Italy

Location

Servizio di Ginecologia Preventiva, Istituti Clinici di Perfezionamento

Milan, 20122, Italy

Location

Clinica Ostetrica Ginecologica Azienda Ospedaliera L. Sacco

Milan, Italy

Location

Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia

Modena, 41100, Italy

Location

Unità Operativa di Ginecologia Oncologica, Ospedale Oncologico M. Ascoli

Palermo, 90127, Italy

Location

Ostetricia e Ginecologia, Ospedale S. Maria delle Grazie

Pozzuoli, 80078, Italy

Location

Ambulatorio di Colposcopia e Patologia Cervico-Vaginale, Università Cattolica del Sacro Cuore

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable 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)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Fausto Boselli, MD

    Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

June 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 7, 2022

Record last verified: 2008-09

Locations

IT(12)