Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-03 @ 10:22 PM
Study NCT ID:
NCT02015260
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2013-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of the Efficacy and Safety of Topical Nitric Oxide in Patients With Anogenital Warts
Sponsor:
University of Aberdeen
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: