A Trial of the Efficacy and Safety of Topical Nitric Oxide in Patients With Anogenital Warts

Inclusion Criteria: * Males and females over 18 years of age * 2-50 warts in the anogenital region. * Female patients of child-bearing potential had to be willing to use a non-barrier method of contraception at entry and for the duration of the study. * all patients had to be willing to use barrier protection for the duration of the study. * All patients had to be able to comply with the requirements of the protocol and be likely to return for follow-up visits and had to be contactable for the duration of the study. Exclusion Criteria: * Patients with clinically relevant abnormal haematology or biochemistry results (determined from the sample taken at Visit 1). * Patients who had used an active therapy for anogenital warts within 2 weeks of randomisation to study drug, i.e. Visit 2. * Patients who had used any local supportive medication, including topical corticosteroids or beta-interferon, within 2 weeks of study entry. * Patients who had used medication known to adversely affect their haematology profile, including local anaesthetics (benzocaine, lidocaine, etc), nitrofurantoin, sulphonylureas and sulphonamides within 2 weeks of study entry. \[Word 'adversely' added by Protocol Amendment 2, 7 May 2002.\] * Patients with abnormal anogenital skin, such as eczema, or skin that had not healed following surgery (cryosurgery, laser ablation or similar). * Patients who were known to have a concomitant sexually transmitted disease that inhibited accurate assessment of their warts. * Patients who required treatment other than surgery or laser for internal warts. * Male patients with intra-urethral warts \[deleted by Protocol Amendment 2, 7 May 2002\]. * Patients with diabetes (Type I or Type II diabetes). * Patients who were known to be HIV-positive. * Patients who were known to be immunosuppressed and/or using immunosuppressive therapies. * Patients known to abuse alcohol and/or drugs or with a history of chronic alcohol or drug abuse.