CompletedPhase 2/3

A Study to Assess the Efficacy of Omnivirol-Salicylic Acid Combination Therapy for Cutaneous Warts With Emphasis on Persistent Warts

Belgium260 participantsStarted 2018-01-01

Plain-language 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. 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.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy of AV2-SA treatment versus standard SA treatment: cure rate

Timeframe: 12 weeks after enrollment

Efficacy of AV2-SA treatment versus standard SA treatment: recurrence rate

Timeframe: 6 months after enrollment

Trial details

NCT IDNCT05862441

SponsorUniversiteit Antwerpen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-31

View on ClinicalTrials.gov More Cutaneous Warts trials