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

Primary Purpose

Anogenital Warts, Condylomata Acuminata

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Topical NO

Placebo

About this trial

This is an interventional treatment trial for Anogenital Warts focused on measuring human papilloma virus infection, Anogenital warts, condylomata acuminata

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

Topical NO Dose A

Topical NO Dose B

Topical NO Dose C

Arm Description

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

3% sodium nitrite + 4.5% citric acid twice daily

6% sodium nitrite + 9% citric acid once daily

6% sodium nitrite + 9% citric acid twice daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Patient assessment of efficacy

Patient assessment of efficacy (categorised as complete clearance, significant improvement, partial improvement, no change or worsening) at Week 12/withdrawal/early completion

Investigator assessment of efficacy

Investigator assessment of efficacy (categorised as complete clearance, significant improvement, partial improvement, no change or worsening) at Week 12/withdrawal/early completion

Patient assessment of tolerability

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

Investigator assessment of tolerability

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)

Safety of treatment

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.

Full Information

NCT ID

NCT02015260

First Posted

August 6, 2013

Last Updated

May 1, 2017

Sponsor

University of Aberdeen

Collaborators

Prostrakan Pharmaceuticals, Erasmus Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02015260

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

September 2001 (undefined)

Primary Completion Date

May 2003 (Actual)

Study Completion Date

May 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aberdeen

Collaborators

Prostrakan Pharmaceuticals, Erasmus Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anogenital Warts, Condylomata Acuminata

Keywords

human papilloma virus infection, Anogenital warts, condylomata acuminata

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

299 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Topical NO Dose A

Arm Type

Active Comparator

Arm Description

3% sodium nitrite + 4.5% citric acid twice daily

Arm Title

Topical NO Dose B

Arm Type

Active Comparator

Arm Description

6% sodium nitrite + 9% citric acid once daily

Arm Title

Topical NO Dose C

Arm Type

Active Comparator

Arm Description

6% sodium nitrite + 9% citric acid twice daily

Intervention Type

Drug

Intervention Name(s)

Topical NO

Other Intervention Name(s)

Acidified Nitrite vs Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo nitrite cream and placebo citric acid cream

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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

Description

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Title

Patient assessment of efficacy

Description

Patient assessment of efficacy (categorised as complete clearance, significant improvement, partial improvement, no change or worsening) at Week 12/withdrawal/early completion

Time Frame

12 weeks

Title

Investigator assessment of efficacy

Description

Investigator assessment of efficacy (categorised as complete clearance, significant improvement, partial improvement, no change or worsening) at Week 12/withdrawal/early completion

Time Frame

12 weeks

Title

Patient assessment of tolerability

Description

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

Time Frame

Title

Investigator assessment of tolerability

Description

Time Frame

12 weeks

Title

Safety of treatment

Description

Time Frame

12 weeks and followed up

Other Pre-specified Outcome Measures:

Title

Investigator assessment of staining

Description

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Willem I Van der Meijden

Organizational Affiliation

Erasmus Medical Centre

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25922903

Citation

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.

Results Reference

derived

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

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