NCT06309420

Clinical Trial to Evaluate Efficacy and Safety of a Cryogenic Medical Device for Treatment of Common and Plantar Warts

Prospective, Single-blinded, Randomized Trial to Evaluate the Efficacy of a Cryogenic Medical Device in Treatment of Common and Plantar Warts Versus a Comparator Product.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Oystershell NV · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Accepted

Summary

The present study was set-up to evaluate clinical efficacy of Pixie CO2 versus a comparator product (Wortie®) for the treatment of common and plantar warts.

Detailed description

The use of cryotherapy has been long known to be effective against warts. The indications for Pixie CO2 are in line with the indications presented in the collected literature data, as well as with the indications of similar devices. The benefits of the use of cryotherapy for warts is clearly evidenced. The treatment period is short (up to 3 treatments with a 14 day interval, compared to daily application of keratinolytics or fluorouracil, over a period of weeks). The cryotherapy application through a conic applicator is much more precise than with most chemical substances. Chemical substance application is leading to more side effects of the surrounding skin (typical for chemical treatment are pain, blistering, ulceration and contact dermatitis). The Instructions for Use were developed in line with these data and are therefore covering all hazards known up to the date of this report. Based on these data the product received its CE-mark approval.

Conditions

• Warts

Interventions

Type	Name	Description
DEVICE	Cryogenic treatment of warts (Pixie CO2)	Treatment of common and plantar warts by cryotherapy treatment.
DEVICE	Cryogenic treatment of warts (Wortie®)	Treatment of common and plantar warts by cryotherapy treatment.

Timeline

• Start date: 2019-11-07
• Primary completion: 2020-08-10
• Completion: 2020-08-10
• First posted: 2024-03-13
• Last updated: 2024-03-13

Locations

1 site across 1 country: Poland