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

NCT07355543 | Recruiting

• 1 other identifier: 25-0952-U5
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Skin Tags

Keywords

NITROFREEZE SKIN TAG; SKIN TAG

Outcome Measures

Primary Outcomes (1)

• Cure rate

  Comparison of the percentage of subjects having a successful treatment of the selected skin tag in the Nitrofreeze Skin Tag group versus comparator group by clinical evaluation by the blinded evaluator. The investigator, who will be in blind of the treatment administered, will measure the selected skin tag height and diameter in mm before treatment on day 0, day 3, day 15, day 30, day 45 and day 60 if applicable. At each timepoint after first treatment session, the blinded investigator will rate the treatment success using the following scale: 0= No change 1. Improvement 2. Disappearance of skin tag The percentage of subjects having a successful treatment at study end will be calculated for the investigational device and comparator. The treatment is considered successful if the blinded investigator scores the selected skin tag as "2". If the score is evaluated as 0 or 1 at a follow-up visit, a new treatment will be done (maximum 3 treatments).

  From enrollment to the end of treatment at 60 days (maximum)

Secondary Outcomes (6)

• Global effectiveness-subjective questionnaire

  Study end (day 15, day 30, day 45 or day 60 according to the treatment success)

• Skin condition

  From enrollment to the end of the treatment at 60 days (maximum)

• Pain during treatment by the subject

  From enrollment to the end of treatment at 60 days (maximum)

• Pain and healing process by the subject

  From enrolment to the end of treatment at 60 days (maximum)

• Global tolerability

  Study end (Day 15, Day 30, Day 45 or Day 60 according to the treatment success)

Study Arms (2)

NITROFREEZE SKIN TAG

EXPERIMENTAL

Topical application on the selected skin tag for 20 seconds. Maximum of 3 treatments with a 15 days interval between each treatment.

Device: NITROFREEZE Skin tag

Scholl Freeze Away Skin Tag Remover

ACTIVE COMPARATOR

Topical application on the selected skin tag for 40 seconds. Skin tag can be removed in 1 treatment. If the skin tag has not fallen off in 2 weeks, you may treat the skin tag again, up to 3 treatment cycles.

Device: Scholl Freeze Away Skin Tag Remover

Interventions

NITROFREEZE Skin tag DEVICE

Treatment of the skin tag with NITROFREEZE Skin Tag device on Day 0, Day 15, Day 30.

NITROFREEZE SKIN TAG

Scholl Freeze Away Skin Tag Remover DEVICE

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

Scholl Freeze Away Skin Tag Remover

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subject.
• Sex: male or female.
• Age: more than 22 years old.
• Phototype: I to III according to Fitzpatrick.
• Subject presenting at least one skin tag that could be treated by the tested devices as evaluated by the investigator:
• Location: on the neck, chest, back, groin or underarm;
• Colour: skin tags must be similar in colour to the surrounding skin;
• Shape \& Feel: skin tags must be soft and flexible.
• Size: 2 to 5 mm in size.
• Subject having given freely and expressly his/her informed consent.
• Subject who is able to comply with the study requirements, as defined in the present CIP, at the investigator's appreciation.
• Subject affiliated to a health social security system.
• Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit and during all the study.

You may not qualify if:

• Pregnant or nursing woman or planning a pregnancy during the study.
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• Subject in a social or sanitary establishment.
• Subject having received 6000 euros indemnities for participation in clinical research in the 12 previous months, including participation in the present study.
• Member of the CRO or the centre staff.
• Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
• Subject suffering from a severe or progressive disease (including asthma and diabetes).
• Subject with immune deficiency or autoimmune disease.
• Subject suffering from an acute or cutaneous disease or any other cutaneous pathology.
• Subject with a history of skin cancer or pre-cancerous skin lesions.
• Subject with previous event of healing disorders such as hypertrophic or keloid scar, residual pigmentation etc.
• Subject with blood circulation or blood clotting problems including Raynaud's disease; blood dyscrasias of unknown origin; haemophilia subjects.
• Subject presenting skin growths such as birthmarks, moles, warts, or any other unusual-looking skin condition on the treated zone.
• Subject having thin, inflamed, damaged, irritated, itchy, infected, cut, grazed, diseased or red skin on and around the treated zone.
• Subject with molluscum contagiosum, blisters or any other vesicles on the skin on and around the treated zone.

Sponsors & Collaborators

• Oystershell NV: lead
• Eurofins Dermscan Pharmascan: collaborator

Study Sites (1)

Eurofins Dermscan Pharmascan

Villeurbanne, 69100, France

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: January 21, 2026
• Study Start: October 6, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)