NCT07355543

Evaluate the Effectiveness and Safety of a Cryogenic Pen to Treat Skin Tags Versus a Comparator.

Prospective, Single Centre, Single-blinded, Randomized Clinical Investigation to Evaluate the Effectiveness and Safety of a Cryogenic Device to Treat Skin Tags Versus a Comparator Product.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Oystershell NV · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical investigation is to evaluate the effectiveness and safety of Nitrofreeze Skin Tag for the treatment of skin tags versus a comparator device (Scholl Freeze Away® Skin Tag Remover).

Detailed description

The primary objective of the study is to assess the efficacy of Nitrofreeze Skin Tag (tested product) for the treatment of skin tags versus a comparator product. The secondary objectives are to assess the safety of the tested product versus comparator product. To meet these objectives, the subjects will be monitored as follows: At the screening visit (visit 1), the study will be explained to the subject by the investigator before any study related procedures are performed. Both the subject and the investigator will sign the consent form and the investigator will check inclusion and exclusion criteria. This can also be done at the D0 visit. At visit 2 on D0, if the subject is eligible, the subject will perform the first treatment on the selected skin tag with the tested product or comparator, at the lab. At visit 3 on D3, the investigator will evaluate the skin condition on and around the skin tag and collect adverse events. At visit 4 on D15, assessment of effectiveness and safety will be made. A second treatment can be done if first treatment is not effective. Study end if the skin tag was successfully removed. At visit 5 on D30, assessment of effectiveness and safety will be made. A third treatment can be done if second treatment is not effective. Study end if the skin tag was successfully removed. At visit 6 on D45, assessment of effectiveness and safety will be made. Study end. In case of missing treatment on D15 or D30 because of a missing visit or a skin condition that did not permit a new treatment, the third treatment will be done on D45. In that case, a new follow-up visit will be done at D60.

Conditions

• Skin Tags

Interventions

Type	Name	Description
DEVICE	NITROFREEZE Skin tag	Treatment of the skin tag with NITROFREEZE Skin Tag device on Day 0, Day 15, Day 30.
DEVICE	Scholl Freeze Away Skin Tag Remover	Treatment of the skin tag with Scholl Freeze Away Skin Tag Remover device on Day 0, Day 15, Day 30.

Timeline

• Start date: 2025-10-06
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: France