a trial of the efficacy and safety of topical nitric oxide in patients with anogenital warts

Conditions: Anogenital Warts; Condylomata Acuminata

Summary: objective to assess the efficacy of the topical application of nitric oxide, delivered using acidified nitrite. design multicentre, randomized, controlled, dose ranging trial. a control arm and three doses of acidified nitrite applied topically for 12 weeks with a further 12 weeks of follow up. setting the trial setting was in european genitourinary medicine clinics participants male and female volunteers over 18 years of age with between 2 and 50 ano-genital warts, 328 were screened for eligibility and 299 subjects from 40 centres were randomised. exclusions pregnancy; concomitant sexually transmitted disease; internal warts requiring treatment other than surgery /laser; diabetes ; human immunodeficiency virus-positive, immunosuppressed and/or using immunosuppressive therapies; drug abuse. interventions compared * control placebo nitrite cream and placebo citric acid cream twice daily * a) 3% sodium nitrite + 4.5% citric acid creams twice daily * b) 6% sodium nitrite + 9% citric acid creams once daily * c) 6% sodium nitrite + 9% citric acid creams twice daily outcomes * primary proportion of patients with complete clearance of target warts secondary * time to clearance * wart area * wart count * patient and investigator assessment of efficacy * safety * tolerability * adherence


Eligibility criteria:
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.

Keywords: human papilloma virus infection anogenital warts condylomata acuminata