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