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Completed

NCT Number: NCT02015260

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

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

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Key information

Conditions

Anogenital Warts Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females over 18 years of age
  • 2-50 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.

Exclusion criteria

  • 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.

Treatment and study plan

Topical NO

Drug

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

Other names: Acidified Nitrite vs Placebo

Placebo

Drug

Placebo

Other names: Placebo nitrite cream and placebo citric acid cream

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 12 weeks

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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.

Other outcomes

  1. Investigator assessment of staining

    Time frame: 12 weeks

    Investigator assessment of staining (present or absent) at treatment site at Weeks 1, 2, 4, 6, 8, 10 and 12/withdrawal/early completion

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • Erasmus Medical Center
  • Kyowa Kirin Co., Ltd.

Registry information

Official study 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 Anogenital Warts

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Dec 19, 2013
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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