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

• Time to recurrence [ Time Frame: n.a. ] [ Designated as safety issue: Yes ]
• Recurrence rate at 4 and 12 weeks post ablation [ Time Frame: 4 and 12 weeks ] [ Designated as safety issue: Yes ]
• Reduction of EGW area [ Time Frame: 4 and 12 weeks ] [ Designated as safety issue: Yes ]
• Healing and cosmetic outcome [ Time Frame: 4, 12 and 24 weeks ] [ Designated as safety issue: Yes ]
• Local and general tolerability [ Time Frame: n.a. ] [ Designated as safety issue: Yes ]
• Percent of complete clearance after initial topical treatment [ Time Frame: up to 6 weeks after initial topical treatment ] [ Designated as safety issue: Yes ]
• Occurrence of new lesions [ Time Frame: n.a. ] [ Designated as safety issue: Yes ]

• ·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.

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).

• 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

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.