Spots Global Cancer Trial Database for A Trial of the Efficacy and Safety of Topical Nitric Oxide in Patients With Anogenital Warts

Study Description

Brief 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

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial