| Eligibility |
Inclusion Criteria:
- Healthy subject
- Sex: male or female
- Age: between 18 and 65 years old
- Type: Caucasion
- Phototype: I to III according to Fitzpatrick
- Subject presenting at least one skin tag that could be treated by the tested devices
on the neck, the breast, or under armpits of 2 to 5 mm diameter.
- 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 being affiliated to a health social security system.
- Female subjects of childbearing potential should use a medically accepted
contraceptive regimen since at least 4 weeks before the beginning of the study and
during all the study.
Exclusion Criteria:
- Pregnant, parturient, nursing woman or woman planning a pregnancy during the study.
- Subject who had been deprived of their freedom by administrative or legal decision.
- Subject who is under guardianship.
- Subject having received 4500 euros indemnities for participation in clinical trials in
the 12 previous months, including participation in the present study.
- Subject currently participating in another research or being in an exclusion period
for a previous study.
- Subject suffering from an acute disease or any other pathology that may interfere with
the evaluation of the study results at the investigator's opinion.
- Subject with a cutaneous disease that may interfere with the evaluation of the study
results or might put the subject at undue risk at the investigator's opinion.
- Subject with a history of skin cancer.
- Subject with a history of pre-cancerous skin lesions.
- Subject with a known allergy to one of the component of the products, to the
comparator, to nickel, to Biseptine® or any other Chlorhexidine based antiseptic or to
the adhesive.
- Subject suffering from asthma.
- Subject who has diabetes.
- Subject with previous event of healing disorders 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 with immune deficiency or autoimmune disease.
- Subject presenting birthmarks, moles, warts, or any other spots on the studied zone.
- Subject having an inflamed, infected, irritated, red, damaged, cut, grazed, diseased
or itchy skin on the treated zone.
- Subject who already had an abnormal reaction to cold.
- Subject whose selected skin tag is bleeding or scratched.
- Subject undergoing a topical treatment on the test area or a systemic treatment:
- anti-inflammatory medication during the previous 5 days and during the study,
- immunosuppressors and/or corticoids during the 10 previous days and during the study,
- retinoids during the 6 previous months and during the study,
- treatment with an action on coagulation during the previous week and during the study,
- any long-term medication stabilized for less than one month.
- Subject who received a treatment of any type on the selected skin tag during the
previous 6 months.
- Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen
exposure of the treated zone during the study.
- Subject planning to change her/his life habits during the study.
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