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
18 Years
N/A
Both
Genital Warts
Trial Information
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
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).
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
recuurence rate 24 weeks after ablative therapy
Outcome Time Frame:
24 weeks
Safety Issue:
Yes
Principal Investigator
Fausto Boselli, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Unità di Ginecologia Preventiva e Oncologica Università di Modena e Reggio Emilia
Authority:
Italy: The Italian Medicines Agency
Study ID:
1526-IMIQ
NCT ID:
NCT00189293
Start Date:
June 2005
Completion Date:
December 2007
Related Keywords:
- Genital Warts
- External Ano-Genital Warts
- Ablative Therapy
- Aldara
- Condylomata Acuminata
- Warts
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