NCT03129373

Clinical Study : Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment

Clinical Trial to Demonstrate the Comparative Efficacy of a Cryogenic Treatment (Medical Device) In Common and Plantar Warts Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (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® cryogenic pen versus two comparator cryogenic products (Wartner® and 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® are in line with the indications presented in the collected literature data, as well as with the indications of equivalent devices. The benefits of warts treatment without the use of chemicals are clearly evidenced. The treatment period is much shorter (one treatment compared to daily application of keratinolytics or fluorouracil, over a period of a few weeks). The cryogen therapy application through a conic tip is much more precise than with 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	Treatment of common and plantar wart by cryotherapy treatment.

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2017-04-26
• Last updated: 2017-09-19