NCT06315946

Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product.

Prospective, Single-blinded, Randomized Trial to Evaluate the Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Oystershell NV · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Skin Tags

Interventions

Type	Name	Description
DEVICE	Pixie® skin tag	The skin tag is treated by treatment with the cryogenic device. To protect the surrounding skin, a protective foam plaster is applied before the device is used on the skin tag. The skin tag is treated for 20 seconds after loading the device for 2 seconds.
DEVICE	Wortie® Skin Tag Remover	The skin tag is treated by treatment with the cryogenic device. The frozen metal nib is applied on the skin tag for 40 seconds.

Timeline

• Start date: 2018-10-04
• Primary completion: 2019-01-07
• Completion: 2019-03-11
• First posted: 2024-03-18
• Last updated: 2024-03-18

Locations

1 site across 1 country: France