Clinical trial · Interventional
A Trial of the Efficacy and Safety of Topical Nitric Oxide in Patients With Anogenital Warts
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anogenital Warts | — | UNRESOLVED | — |
| Condylomata Acuminata | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Topical NO | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- placebo 0% nitrite cream and placebo 0% citric acid cream
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Topical NO Dose A
- description
- 3% sodium nitrite + 4.5% citric acid twice daily
- interventionNames
- Drug: Topical NO
- type
- ACTIVE_COMPARATOR
- label
- Topical NO Dose B
- description
- 6% sodium nitrite + 9% citric acid once daily
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDOrmerod 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 25922903