Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309420
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2022-12-16
Brief Title:
Clinical Trial to Evaluate Efficacy and Safety of a Cryogenic Medical Device for Treatment of Common and Plantar Warts
Sponsor:
Oystershell NV
Organization:
Oystershell NV
Study Overview
Official Title:
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
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None