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

Exclusion Criteria28

• 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,
• any long-term medication stabilized for less than one month.
• Subject who received a treatment of any kind on the selected skin tag within 6 months prior to D0 visit.
• Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen exposure of the treated zone during the study.