NCT02015260

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 efficacy
  • Safety
  • Tolerability
  • Adherence

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
10.3 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
Last Updated

May 3, 2017

Status Verified

December 1, 2013

Enrollment Period

1.7 years

First QC Date

August 6, 2013

Last Update Submit

May 1, 2017

Conditions

Anogenital WartsCondylomata Acuminata

Keywords

human papilloma virus infectionAnogenital wartscondylomata acuminata

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with complete clearance of target warts in Intention to treat (ITT) population

    * 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

    24 weeks

Secondary Outcomes (6)

  • Total number of warts (baseline and new) at end of treatment

    12 weeks

  • Patient assessment of efficacy

    12 weeks

  • Investigator assessment of efficacy

    12 weeks

  • Patient assessment of tolerability

    12

  • Investigator assessment of tolerability

    12 weeks

  • +1 more secondary outcomes

Other Outcomes (1)

  • Investigator assessment of staining

    12 weeks

Study Arms (4)

placebo

PLACEBO COMPARATOR

placebo 0% nitrite cream and placebo 0% citric acid cream

Drug: Placebo

Topical NO Dose A

ACTIVE COMPARATOR

3% sodium nitrite + 4.5% citric acid twice daily

Drug: Topical NO

Topical NO Dose B

ACTIVE COMPARATOR

6% sodium nitrite + 9% citric acid once daily

Drug: Topical NO

Topical NO Dose C

ACTIVE COMPARATOR

6% sodium nitrite + 9% citric acid twice daily

Drug: Topical NO

Interventions

Topical NODRUG

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

Also known as: Acidified Nitrite vs Placebo
Topical NO Dose ATopical NO Dose BTopical NO Dose C
PlaceboDRUG

Placebo

Also known as: Placebo nitrite cream and placebo citric acid cream
placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females over 18 years of age
  • warts in the anogenital region.
  • Female patients of child-bearing potential had to be willing to use a non-barrier method of contraception at entry and for the duration of the study.
  • all patients had to be willing to use barrier protection for the duration of the study.
  • All patients had to be able to comply with the requirements of the protocol and be likely to return for follow-up visits and had to be contactable for the duration of the study.

You may not qualify if:

  • Patients with clinically relevant abnormal haematology or biochemistry results (determined from the sample taken at Visit 1).
  • Patients who had used an active therapy for anogenital warts within 2 weeks of randomisation to study drug, i.e. Visit 2.
  • Patients who had used any local supportive medication, including topical corticosteroids or beta-interferon, within 2 weeks of study entry.
  • Patients who had used medication known to adversely affect their haematology profile, including local anaesthetics (benzocaine, lidocaine, etc), nitrofurantoin, sulphonylureas and sulphonamides within 2 weeks of study entry. \[Word 'adversely' added by Protocol Amendment 2, 7 May 2002.\]
  • Patients with abnormal anogenital skin, such as eczema, or skin that had not healed following surgery (cryosurgery, laser ablation or similar).
  • Patients who were known to have a concomitant sexually transmitted disease that inhibited accurate assessment of their warts.
  • Patients who required treatment other than surgery or laser for internal warts.
  • Male patients with intra-urethral warts \[deleted by Protocol Amendment 2, 7 May 2002\].
  • Patients with diabetes (Type I or Type II diabetes).
  • Patients who were known to be HIV-positive.
  • Patients who were known to be immunosuppressed and/or using immunosuppressive therapies.
  • Patients known to abuse alcohol and/or drugs or with a history of chronic alcohol or drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ormerod AD, van Voorst Vader PC, Majewski S, Vanscheidt W, Benjamin N, van der Meijden W. Evaluation of the Efficacy, Safety, and Tolerability of 3 Dose Regimens of Topical Sodium Nitrite With Citric Acid in Patients With Anogenital Warts: A Randomized Clinical Trial. JAMA Dermatol. 2015 Aug;151(8):854-61. doi: 10.1001/jamadermatol.2015.0381.

    PMID: 25922903DERIVED

MeSH Terms

Conditions

Condylomata AcuminataPapillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsGenital DiseasesUrogenital DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Willem I Van der Meijden

    Erasmus Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2013

First Posted

December 19, 2013

Study Start

September 1, 2001

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

May 3, 2017

Record last verified: 2013-12

Data Sharing

IPD Sharing
Will not share