NCT02015260

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

A Randomised, Multicentre, Double-blind, Placebo-controlled, Dose-ranging Trial to Evaluate the Efficacy, Safety and Tolerability of Three Dose Regimens of Topical Nitric Oxide in Patients With Anogenital Warts

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: University of Aberdeen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Anogenital Warts
• Condylomata Acuminata

Interventions

Type	Name	Description
DRUG	Topical NO	Varying doses of sodium nitrite and citric acid co-applied to warts
DRUG	Placebo	Placebo

Timeline

• Start date: 2001-09-01
• Primary completion: 2003-05-01
• Completion: 2003-05-01
• First posted: 2013-12-19
• Last updated: 2017-05-03