Clinical Trials Logo
  1. Home
  2. Condylomata Acuminata
  3. NCT02015260

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

Condylomata Acuminata Clinical Trial

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 Anogenital Warts

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02015260
Study type Interventional
Source University of Aberdeen
Contact
Status Completed
Phase Phase 2
Start date September 2001
Completion date May 2003
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04537156 - Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli) Phase 3
Completed NCT00090285 - An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020) Phase 3
Completed NCT00973856 - Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands N/A
Active, not recruiting NCT05056402 - An Immuno-bridging Study of a Nonavalent HPV Vaccine (E.Coli) in Healthy Population Aged 9-17 vs Aged 18-26 Years Old Phase 3
Withdrawn NCT00365443 - Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study (V502-003) Phase 2
Not yet recruiting NCT01483794 - Epidemiology, Costs and Psychosocial Consequences of Genital Warts in Valparaiso, Chile N/A
Completed NCT03935204 - Immunogenicity Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli) Phase 2
Completed NCT02405520 - Safety and Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine Phase 1
Active, not recruiting NCT02710851 - Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine Phase 2
Completed NCT04782895 - Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) Versus Gardasil®9 in Healthy Females 18-26 Years of Age Phase 3
Completed NCT03546842 - Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017) Phase 3
Completed NCT03981822 - A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts Phase 2
Recruiting NCT03158480 - Safety and Efficacy of Immune Therapy for Condyloma N/A
Completed NCT01598779 - Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population N/A
Completed NCT00449982 - Efficacy and Safety Study of Polyphenon E to Treat External Genital Warts Phase 3
Completed NCT03813940 - Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli) Phase 1
Not yet recruiting NCT06197802 - Plateau Antibody Levels of a Recombinant (E.Coli) HPV Nonavalent Vaccine Versus Gardasil®9 in Young Women
Completed NCT01532102 - Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts Phase 1/Phase 2
Active, not recruiting NCT06297187 - Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study
Not yet recruiting NCT03853785 - Efficacy of Intralesional MMR Vaccine,Intralesional Candidal Antigen&Topical Podophyllin in Treatment of Genital Warts Phase 3