We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Imiquimod Cream Prior to Ablative Therapy in External Ano-Genital Warts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00189293
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 6, 2011
Sponsor:
Information provided by:
MEDA Pharma GmbH & Co. KG

September 12, 2005
September 19, 2005
January 6, 2011
June 2005
December 2007   (Final data collection date for primary outcome measure)
recuurence rate 24 weeks after ablative therapy [ Time Frame: 24 weeks ]
Recurrence rate at 24 weeks after ablative therapy.
Complete list of historical versions of study NCT00189293 on ClinicalTrials.gov Archive Site
  • Time to recurrence [ Time Frame: n.a. ]
  • Recurrence rate at 4 and 12 weeks post ablation [ Time Frame: 4 and 12 weeks ]
  • Reduction of EGW area [ Time Frame: 4 and 12 weeks ]
  • Healing and cosmetic outcome [ Time Frame: 4, 12 and 24 weeks ]
  • Local and general tolerability [ Time Frame: n.a. ]
  • Percent of complete clearance after initial topical treatment [ Time Frame: up to 6 weeks after initial topical treatment ]
  • Occurrence of new lesions [ Time Frame: n.a. ]
  • ·Time to recurrence.
  • ·Recurrence rate at 4 and 12 weeks post ablation.
  • ·Reduction of EGW area.
  • ·Healing and cosmetic outcome.
  • ·Local and general tolerability
  • ·Percent of complete clearance after initial topical treatment.
  • ·Occurrence of new lesions.
Not Provided
Not Provided
 
Study of Imiquimod Cream Prior to Ablative Therapy in External Ano-Genital Warts
Multicenter, Randomised, Double-blind, Vehicle-controlled Study Comparing Recurrence Rate Following Imiquimod 5% Cream or Vehicle 3 Times Per Week for 4 Weeks Prior to Ablative Therapy in Subjects Suffering From External Ano-Genital Warts
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.
To compare the recurrence rate 24 weeks after ablative therapy in subjects with external genital warts trated with imiquimod, 3 applications per week for 4 weeks followed by ablative therapy versus vehicle, 3 applications per week for 4 weeks followed by ablative therapy. A recurrence is defined as the investoigator-assessed occurrence of lesion(s) within the baseline area cleared by the treatment: imiquimod/vehicle then ablative therapy (either the initial ablative therápy session (A0), or if required for complete clearance of baseline lesions, a second ablative therapy session (A2).
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Genital Warts
  • Drug: Imiquimod

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

    1 or 2 sachet(s)

  • Other: vehicle cream

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

    1 or 2 sachet(s)

  • Experimental: 1
    Imiquimod 5% cream
    Intervention: Drug: Imiquimod
  • 2
    vehicle cream
    Intervention: Other: vehicle cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
December 2007
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00189293
1526-IMIQ
2004-004654-19 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Joachim Maus, MD, Director Clinical Development, Meda Pharma GmbH & Co. KG
MEDA Pharma GmbH & Co. KG
Not Provided
Principal Investigator: Fausto Boselli, MD Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia
MEDA Pharma GmbH & Co. KG
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP