Anogenital WartsPhase 2NCT02015260
A Trial of the Efficacy and Safety of Topical Nitric Oxide in Patients With Anogenital Warts
A Phase 2 study testing Topical NO in people with Anogenital Warts and Condylomata Acuminata, run by University of Aberdeen.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anogenital Warts, Condylomata Acuminata
- What is being tested?
- Topical NO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 299 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to May 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
About this study
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
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.
Read more
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
- Anogenital Warts, Condylomata Acuminata
- Being tested
- Topical NO, Placebo
- Keywords
- human papilloma virus infection, Anogenital warts, condylomata acuminata
- Medical subject headings
- Condylomata Acuminata, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical NODrug
Also called Acidified Nitrite vs Placebo
Varying doses of sodium nitrite and citric acid co-applied to warts
PlaceboDrug
Also called Placebo nitrite cream and placebo citric acid cream
Placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo 0% nitrite cream and placebo 0% citric acid cream Receives: Drug: Placebo |
| Topical NO Dose A | Active comparator | 3% sodium nitrite + 4.5% citric acid twice daily Receives: Drug: Topical NO |
| Topical NO Dose B | Active comparator | 6% sodium nitrite + 9% citric acid once daily Receives: Drug: Topical NO |
| Topical NO Dose C | Active comparator | 6% sodium nitrite + 9% citric acid twice daily Receives: Drug: Topical NO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (6)
Total number of warts (baseline and new) at end of treatment
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12
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)
Measured: 12 weeks
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.
Measured: 12 weeks and followed up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startSep 2001
- Primary completionMay 2003
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anogenital WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- Kyowa Kirin Co., Ltd., Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Willem I Van der Meijden, Principal investigator, Erasmus Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015260
- Sponsor's protocol ID
- ANA/2/C
- Status last verified
- Dec 2013
- First submitted
- 6 Aug 2013
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25922903
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02015260
- Acronym / sponsor ID
- ANA/2/C
- Conditions
- Anogenital Warts, Condylomata Acuminata
- Keywords
- human papilloma virus infection, Anogenital warts, condylomata acuminata
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- Kyowa Kirin Co., Ltd., Erasmus Medical Center
- Study start
- Sep 2001
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placeboplacebo 0% nitrite cream and placebo 0% citric acid cream |
| Topical NO Dose A | Active comparator | Drug: Topical NO3% sodium nitrite + 4.5% citric acid twice daily |
| Topical NO Dose B | Active comparator | Drug: Topical NO6% sodium nitrite + 9% citric acid once daily |
| Topical NO Dose C | Active comparator | Drug: Topical NO6% sodium nitrite + 9% citric acid twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical NOAlso: Acidified Nitrite vs PlaceboVarying doses of sodium nitrite and citric acid co-applied to warts | Drug | Topical NO Dose A, Topical NO Dose B, Topical NO Dose C |
| PlaceboAlso: Placebo nitrite cream and placebo citric acid creamPlacebo | Drug | placebo |
Primary outcome
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
6 secondary outcomes
Total number of warts (baseline and new) at end of treatment
Time frame: 12 weeks
Patient assessment of efficacy
Time frame: 12 weeks
Investigator assessment of efficacy
Time frame: 12 weeks
Patient assessment of tolerability
Time frame: 12
Investigator assessment of tolerability
Time frame: 12 weeks
Safety of treatment
Time frame: 12 weeks and followed up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Derived from this study: PubMed 25922903Ormerod 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.
- Individual participant dataSharing planned: No
Related trials for Anogenital Warts
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the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willem I Van der Meijden principal investigator
Erasmus Medical Centre
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical NO in people with Anogenital Warts and Condylomata Acuminata, run by University of Aberdeen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with complete clearance of target warts in Intention to treat (ITT) population (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02015260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.