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.
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.
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).
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.
Inclusion Criteria:
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:
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.
Exclusion Criteria:
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:
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.