Cutaneous WartsPhase 2/3OVW-SA001NCT05862441
A Study to Assess the Efficacy of Omnivirol-Salicylic Acid Combination Therapy for Cutaneous Warts With Emphasis on Persistent Warts
A Phase 2/3 study testing AV2-SA2 and SA in people with Cutaneous Warts, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
Cutaneous warts comprise an extremely common condition caused by infection with the human papillomavirus (HPV). Although most verrucae will disappear spontaneously, many patients do seek treatment. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cutaneous Warts
- What is being tested?
- AV2-SA2 and SA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2018to 31 Dec 2019
- Phase
- Phase 2/3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must exhibit one or more cutaneous warts.
- Must agree to refrain from using prescription or supplemental antiviral medications without first obtaining permission of the attending healthcare professional.
- Must be 12 years or older.
- Must be able to read Dutch.
- Must be willing to sign informed consent.
- Must be willing and able to self-assess and use WhatsApp, a freely available messaging application, for follow-up.
Who cannot join
- Exhibits only seborrheic and/or facial warts. Salicylic acid treatment is not suitable for facial warts. Seborrheic warts are not caused by HPV infection.
- Is immunocompromised.
- Has already participated in another clinical trial concerning treatment for cutaneous warts within six months before enrollment in this study or currently is in a trial evaluating other treatments for his/hers warts.
- Has a medical history of any severe diseases like hepatitis, renal or liver dysfunction, cardiovascular, gastrointestinal, malignant tumors, or psychiatric disorders, etc., which might influence the assessments or conduct of the trial by the discretion of the investigator.
- Has known or suspected allergic or adverse response to the investigational product AV2, its components or salicylic acid.
- Has impaired healing or neuropathy, for example owing to diabetes, peripheral vascular disease or any other condition.
Trial locations and contacts
1 site in 1 country.
About this study
Cutaneous warts comprise an extremely common condition caused by infection with the human papillomavirus (HPV). Although most verrucae will disappear spontaneously, many patients do seek treatment. Current wart treatments do not target the cause of the lesion directly, resulting in variable treatment efficacies and high wart recurrence rates. AV2 is a broad-spectrum antiviral drug, that is capable of deactivating HPV. It is however not able to destruct the already infected cells, which raises the need for an additional ablative treatment i.e. salicylic acid (SA). Implementation of AV2-Salicylic acid (AV2-SA) combination therapy would ensure permanent lesion clearance by on the one hand inactivation of HPV by AV2, and on the other hand elimination of the lesion by SA treatment. The primary aim of this study is to assess the efficacy of AV2-SA treatment versus standard SA treatment, by comparing cure and recurrence rates of cutaneous warts between the two treatment groups (at 12 weeks and six months after randomization). The second aim is to assess the safety and tolerability of AV2-SA therapy. The third aim is to identify subgroups of cutaneous warts that have favorable response to treatment, by comparing cure rates in an HPV genotype-specific manner. This randomized controlled trial will enroll 260 participants with cutaneous warts who will either receive the AV2-SA combination therapy or SA control treatment. Real time monitoring will be possible by daily photographs sent via WhatsApp TM (a messaging application) as well as online follow-up questionnaires administered on several occasions. HPV genotyping will be performed on swab self-samples.
- Conditions
- Cutaneous Warts
- Being tested
- AV2-SA2, SA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV2-SA2Drug
AV2 is a combination of FDA GRAS-label approved organic compounds (natural essential oils: carvone, eugenol, geraniol, and nerolidol) that is postulated to be able to prevent viral entry and proliferation by deactivating the infectious virions before they enter the cell. Salicylic acid (SA) formulations are the most commonly used preparations in the treatment of warts. SA is an organic acid that destroys epidermal cells and softens hyperkeratotic epidermis. Implementation of AV2-SA combination therapy would ensure permanent lesion clearance by on the one hand inactivation of HPV by AV2, and on the other hand elimination of the lesion by SA treatment.
SADrug
Salicylic acid (SA) formulations are the most commonly used preparations in the treatment of warts. SA is an organic acid that destroys epidermal cells and softens hyperkeratotic epidermis.
| Study group | Role | What they receive |
|---|---|---|
| AV2-SA | Experimental | 100% AV2 (v/v) - 17% SA (w/v) treatment one drop daily and 10% AV2 (v/v) spray one puff weekly Receives: Drug: AV2-SA2 |
| SA | Active comparator | 100% d-carvone (v/v) - 17% SA (w/v) treatment one drop daily and 10% d-carvone (v/v) spray one puff weekly Receives: Drug: SA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of AV2-SA treatment versus standard SA treatment: cure rate
To assess the efficacy of AV2-SA treatment versus standard SA treatment by comparing cure rates of the index warts between the two treatment groups at 12 weeks after enrollment.
Measured: 12 weeks after enrollment
Efficacy of AV2-SA treatment versus standard SA treatment: recurrence rate
To assess the efficacy of AV2-SA treatment versus standard SA treatment by comparing recurrence rates of the index warts between the two treatment groups at 6 months after enrollment.
Measured: 6 months after enrollment
Secondary outcomes (6)
Number of participants with treatment-related adverse events in the AV2-SA treatment group versus the standard SA treatment group.
The safety of both treatments will be assessed by monthly questionnaires actively asking the participants if they experienced any pain or other treatment-related adverse events. Pain will be measured with a scale of 1 to 4, with score 1 representing no pain at all and score 4 extreme pain.
Measured: 12 weeks after enrollment
To compare time to clearance of index wart between the two treatment groups
Measured: 6 months after enrollment
To compare change in size of index wart between the two treatment groups
Measured: 6 months after enrollment
To compare number of verrucae remaining between the two treatment arms
Measured: 6 months after enrollment
To determine the genotype-specific distribution of wart-associated HPV types in a Belgian population (according to the age, wart location, postal code, etc.)
Measured: through study completion, an average of 1 year
To investigate the prevalence of mucosal HPV types in cutaneous warts
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 Cutaneous 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Redzic, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862441
- Sponsor's protocol ID
- OVW-SA001
- Acronym
- OVW-SA001
- Status last verified
- May 2023
- First submitted
- 23 Apr 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Redzic N, Pereira AR, Menon S, Bogers J, Coppens A, Kehoe K, Vanden Broeck D. Characterization of type-specific HPV prevalence in a population of persistent cutaneous warts in Flanders, Belgium. Sci Rep. 2023 Oct 15;13(1):17492. doi: 10.1038/s41598-023-44154-y.
PubMed 37840107
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Efficacy of Omnivirol-Salicylic Acid Combination Therapy for Cutaneous Warts With Emphasis on Persistent Warts
- ClinicalTrials.gov ID
- NCT05862441
- Acronym / sponsor ID
- OVW-SA001 / OVW-SA001
- Conditions
- Cutaneous Warts
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 May 2023 (actual)
- 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.
Cutaneous warts comprise an extremely common condition caused by infection with the human papillomavirus (HPV). Although most verrucae will disappear spontaneously, many patients do seek treatment. Current wart treatments do not target the cause of the lesion directly, resulting in variable treatment efficacies and high wart recurrence rates. AV2 is a broad-spectrum antiviral drug, that is capable of deactivating HPV. It is however not able to destruct the already infected cells, which raises the need for an additional ablative treatment i.e. salicylic acid (SA). Implementation of AV2-Salicylic acid (AV2-SA) combination therapy would ensure permanent lesion clearance by on the one hand inactivation of HPV by AV2, and on the other hand elimination of the lesion by SA treatment. The primary aim of this study is to assess the efficacy of AV2-SA treatment versus standard SA treatment, by comparing cure and recurrence rates of cutaneous warts between the two treatment groups (at 12 weeks and six months after randomization). The second aim is to assess the safety and tolerability of AV2-SA therapy. The third aim is to identify subgroups of cutaneous warts that have favorable response to treatment, by comparing cure rates in an HPV genotype-specific manner. This randomized controlled trial will enroll 260 participants with cutaneous warts who will either receive the AV2-SA combination therapy or SA control treatment. Real time monitoring will be possible by daily photographs sent via WhatsApp TM (a messaging application) as well as online follow-up questionnaires administered on several occasions. HPV genotyping will be performed on swab self-samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AV2-SA | Experimental | Drug: AV2-SA2100% AV2 (v/v) - 17% SA (w/v) treatment one drop daily and 10% AV2 (v/v) spray one puff weekly |
| SA | Active comparator | Drug: SA100% d-carvone (v/v) - 17% SA (w/v) treatment one drop daily and 10% d-carvone (v/v) spray one puff weekly |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Must exhibit one or more cutaneous warts.
- Must agree to refrain from using prescription or supplemental antiviral medications without first obtaining permission of the attending healthcare professional.
- Must be 12 years or older.
- Must be able to read Dutch.
- Must be willing to sign informed consent.
Key exclusion criteria (6 listed)
- Exhibits only seborrheic and/or facial warts. Salicylic acid treatment is not suitable for facial warts. Seborrheic warts are not caused by HPV infection.
- Is immunocompromised.
- Has already participated in another clinical trial concerning treatment for cutaneous warts within six months before enrollment in this study or currently is in a trial evaluating other treatments for his/hers warts.
- Has a medical history of any severe diseases like hepatitis, renal or liver dysfunction, cardiovascular, gastrointestinal, malignant tumors, or psychiatric disorders, etc., which might influence the assessments or conduct of the trial by the discretion of the investigator.
- Has known or suspected allergic or adverse response to the investigational product AV2, its components or salicylic acid.
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 |
|---|---|---|
| AV2-SA2AV2 is a combination of FDA GRAS-label approved organic compounds (natural essential oils: carvone, eugenol, geraniol, and nerolidol) that is postulated to be able to prevent viral entry and proliferation by deactivating the infectious virions before they enter the cell. Salicylic acid (SA) formulations are the most commonly used preparations in the treatment of warts. SA is an organic acid that destroys epidermal cells and softens hyperkeratotic epidermis. Implementation of AV2-SA combination therapy would ensure permanent lesion clearance by on the one hand inactivation of HPV by AV2, and on the other hand elimination of the lesion by SA treatment. | Drug | AV2-SA |
| SASalicylic acid (SA) formulations are the most commonly used preparations in the treatment of warts. SA is an organic acid that destroys epidermal cells and softens hyperkeratotic epidermis. | Drug | SA |
Primary outcome
Efficacy of AV2-SA treatment versus standard SA treatment: cure rate
Time frame: 12 weeks after enrollment
To assess the efficacy of AV2-SA treatment versus standard SA treatment by comparing cure rates of the index warts between the two treatment groups at 12 weeks after enrollment.
Efficacy of AV2-SA treatment versus standard SA treatment: recurrence rate
Time frame: 6 months after enrollment
To assess the efficacy of AV2-SA treatment versus standard SA treatment by comparing recurrence rates of the index warts between the two treatment groups at 6 months after enrollment.
6 secondary outcomes
Number of participants with treatment-related adverse events in the AV2-SA treatment group versus the standard SA treatment group.
Time frame: 12 weeks after enrollment
To compare time to clearance of index wart between the two treatment groups
Time frame: 6 months after enrollment
To compare change in size of index wart between the two treatment groups
Time frame: 6 months after enrollment
To compare number of verrucae remaining between the two treatment arms
Time frame: 6 months after enrollment
To determine the genotype-specific distribution of wart-associated HPV types in a Belgian population (according to the age, wart location, postal code, etc.)
Time frame: through study completion, an average of 1 year
To investigate the prevalence of mucosal HPV types in cutaneous warts
Time frame: through study completion, an average of 1 year
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 17 May 2023.
- Derived from this study: PubMed 37840107Redzic N, Pereira AR, Menon S, Bogers J, Coppens A, Kehoe K, Vanden Broeck D. Characterization of type-specific HPV prevalence in a population of persistent cutaneous warts in Flanders, Belgium. Sci Rep. 2023 Oct 15;13(1):17492. doi: 10.1038/s41598-023-44154-y.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AV2-SA2 and SA in people with Cutaneous Warts, run by Universiteit Antwerpen at 1 site in Belgium.
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 6 inclusion and 6 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 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy of AV2-SA treatment versus standard SA treatment: cure rate (time frame: 12 weeks after enrollment). The study lists 2 primary outcomes in all. 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 NCT05862441, 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 17 May 2023.