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

Recruiting now · Not applicable

Conditions studied: Skin Tags

In brief

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).

Key facts

Study ID: NCT07355543
Run by: Oystershell NV
People needed: 56
Starts: 2025-10-06
Expected to finish: 2026-01-01
Last updated by the study team: 2026-01-21

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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.
Subject enrolled in another clinical trial or which exclusion period is not over.
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.
Subject with a known allergy to Chlorhexidine based antiseptic or to adhesives.
Subject who already had an abnormal reaction to cold.
Subject whose selected skin tag is bleeding or scratched.
Subject whose skin tag is located on the face, scalp or mucosa, anus, genitals, buttocks, lips, eyelids or eyes.
Subject undergoing a topical treatment on the test area or a systemic treatment:
anti-inflammatory medication within 5 days prior to D0 visit,
immunosuppressors and/or corticoids within 10 days prior to D0 visit,
retinoids within 6 months prior to D0 visit,
treatment with an action on coagulation within 1 week prior to D0 visit,

Where it is running

Eurofins Dermscan Pharmascan — Villeurbanne, France (enrolling)

Full record on ClinicalTrials.gov

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