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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00189293

Enrollment

128

Registered

2005-09-19

Start date

2005-06-30

Completion date

2007-12-31

Last updated

2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genital Warts

Keywords

External Ano-Genital Warts, Ablative Therapy, Aldara

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.

Detailed description

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).

Interventions

DRUGImiquimod

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

OTHERvehicle cream

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
recuurence rate 24 weeks after ablative therapy	24 weeks

Secondary

Measure	Time frame
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
Time to recurrence	—
Percent of complete clearance after initial topical treatment	up to 6 weeks after initial topical treatment
Occurrence of new lesions	—
Local and general tolerability	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026