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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
260
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.
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.
University of Antwerp
Antwerp, Belgium
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.
Time frame: 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.
Time frame: 6 months after enrollment
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.
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
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