Clinical Trial: A Trial of the Efficacy and Safety of Topical Nitric Oxide in Patients With Anogenital Warts
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Anogen
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 e
Detailed Summary:
Sponsor: University of Aberdeen
Current Primary Outcome: Proportion of patients with complete clearance of target warts in Intention to treat (ITT) population [ Time Frame: 24 weeks ]
- Number of and area of target warts (up to 10 selected) at Baseline and Week 1, 2, 4, 6, 8, 10 and 12/withdrawal/early completion and at follow-up (Weeks 4, 8 and 12 after end of treatment)
- Number of warts at Baseline (Week 0) and of remaining baseline warts at Week 1, 2, 4, 6, 8, 10 and 12/withdrawal/early completion and at Weeks 4, 8 and 12 of follow-up
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Total number of warts (baseline and new) at end of treatment [ Time Frame: 12 weeks ]
- Patient assessment of efficacy [ Time Frame: 12 weeks ]Patient assessment of efficacy (categorised as complete clearance, significant improvement, partial improvement, no change or worsening) at Week 12/withdrawal/early completion
- Investigator assessment of efficacy [ Time Frame: 12 weeks ]Investigator assessment of efficacy (categorised as complete clearance, significant improvement, partial improvement, no change or worsening) at Week 12/withdrawal/early completion
- Patient assessment of tolerability [ Time Frame: 12 ]Patient assessment of itching, pain and burning (categorised as none, mild, moderate or severe) at treatment site at Screening and Weeks 1, 2, 4, 6, 8, 10 and 12/withdrawal/early completion
- Investigator assessment of tolerability [ Time Frame: 12 weeks ]Investigator assessment of erythema/eschar and oedema (using modified Draize scales from 0 to 4) at Baseline (Week 0), Weeks 1, 2, 4, 6, 8, 10 and 12/withdrawal/early completion and at follow-up (Weeks 4, 8 and 12 after end of treatment)
- Safety of treatment [ Time Frame: 12 weeks and followed up ]Adverse events throughout treatment period; unresolved events at end of treatment were followed up Heart rate and blood pressure at each visit during treatment Laboratory tests at Screening and Week 12/withdrawal/early completion Physical examination at Screening and at Week 12/withdrawal/early completion.
Original Secondary Outcome: Same as current
Information By: University of Aberdeen
Dates:
Date Received: August 6, 2013
Date Started: September 2001
Date Completion:
Last Updated: May 1, 2017
Last Verified: December 2013