Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315946
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2024-03-12
Brief Title:
Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product
Sponsor:
Oystershell NV
Organization:
Oystershell NV
Study Overview
Official Title:
Prospective Single-blinded Randomized Trial to Evaluate the Efficacy of a Cryogenic Medical Device on Skin Tags 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:
Evaluate the efficacy of the test medical device Pixie skin tag in the treatment of skin tags versus a comparator product Wortie skin tag remover
Detailed Description:
The main objective of the study was to evaluate the efficacy of the test medical device Pixie skin tag in the treatment of skin tags versus a comparator product Wortie skin tag remover Non-inferiority of the test product versus competitor on skin tag evaluated by clinical evaluation
The secondary objectives of the study were to evaluate
the number of treatments needed for the complete disappearance of skin tag
the efficacy of devices by subjects self-assessment
the cutaneous tolerability safety
The last objective of the study was to illustrate the expected visual effects
The secondary objectives of the study were to evaluate
the number of treatments needed for the complete disappearance of skin tag
the efficacy of devices by subjects self-assessment
the cutaneous tolerability safety
The last objective of the study was to illustrate the expected visual effects
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