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

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

Timeline

Start

2001-09

Primary completion

2003-05

Completion

2003-05

Publications

• Ormerod AD, van Voorst Vader PC, Majewski S, Vanscheidt W, Benjamin N, van der Meijden W. Evaluation of the Efficacy, Safety, and Tolerability of 3 Dose Regimens of Topical Sodium Nitrite With Citric Acid in Patients With Anogenital Warts: A Randomized Clinical Trial. JAMA Dermatol. 2015 Aug;151(8):854-61. doi: 10.1001/jamadermatol.2015.0381.

Drugs

Indications