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

NCT ID: NCT05862441

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-12-31

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.

Conditions

Cutaneous Warts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AV2-SA

100% AV2 (v/v) - 17% SA (w/v) treatment one drop daily and 10% AV2 (v/v) spray one puff weekly

Group Type: EXPERIMENTAL

AV2-SA2

Intervention Type: DRUG

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.

SA

100% d-carvone (v/v) - 17% SA (w/v) treatment one drop daily and 10% d-carvone (v/v) spray one puff weekly

Group Type: ACTIVE_COMPARATOR

SA

Intervention Type: DRUG

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.

Interventions

AV2-SA2

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.

Intervention Type: DRUG

SA

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiteit Antwerpen

OTHER

Sponsor Role: lead

Responsible Party

Nina Redzic

Study Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Antwerp

Antwerp, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 37840107 (View on PubMed)

Other Identifiers

OVW-SA001

Identifier Type: -

Identifier Source: org_study_id