Clinical trial NCT05862441: A Study to Assess the Efficacy of Omnivirol-Salicylic Acid Combination Therapy for Cutaneous Warts With Emphasis on Persistent Warts
Official title: A Study to Assess the Efficacy of Omnivirol-Salicylic Acid Combination Therapy for Cutaneous Warts With Emphasis on Persistent Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cutaneous Warts
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 260
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of AV2-SA treatment versus standard SA treatment: cure rate
timeFrame: 12 weeks after enrollment
measure: Efficacy of AV2-SA treatment versus standard SA treatment: recurrence rate
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: Number of participants with treatment-related adverse events in the AV2-SA treatment group versus the standard SA treatment group.
timeFrame: 12 weeks after enrollment
measure: To compare time to clearance of index wart between the two treatment groups
timeFrame: 6 months after enrollment
measure: To compare change in size of index wart between the two treatment groups
timeFrame: 6 months after enrollment
measure: To compare number of verrucae remaining between the two treatment arms
timeFrame: 6 months after enrollment
measure: To determine the genotype-specific distribution of wart-associated HPV types in a Belgian population (according to the age, wart location, postal code, etc.)
timeFrame: through study completion, an average of 1 year
measure: To investigate the prevalence of mucosal HPV types in cutaneous warts
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University of Antwerp
Study officials:
References: