Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT02015260
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
Study:
NCT02015260
Study Brief:
Protocol Section:
NCT02015260