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

Condylomata Acuminata Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02015260
Study type Interventional
Source University of Aberdeen
Contact
Status Completed
Phase Phase 2
Start date September 2001
Completion date May 2003
View Details
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