A Trial of the Efficacy and Safety of Topical Nitric Oxide in Patients With Anogenital Warts
Status:
Completed
Trial end date:
2003-05-01
Target enrollment:
Participant gender:
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