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

NCT02015260 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 299

Last updated 2017-05-03

No results posted yet for this study

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

Conditions

  • Anogenital Warts
  • Condylomata Acuminata

Interventions

DRUG

Topical NO

Varying doses of sodium nitrite and citric acid co-applied to warts

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    collaborator INDUSTRY

  • Erasmus Medical Center

    collaborator OTHER

  • University of Aberdeen

    lead OTHER

Principal Investigators

  • Willem I Van der Meijden · Erasmus Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2003-05-31
Completion
2003-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02015260 on ClinicalTrials.gov