Efficacy of a Cryogenic Medical Device on Skin Tags Versus a Comparator Product.

Oystershell

Status

Completed

Conditions

Skin Tags

Treatments

Device: Wortie® Skin Tag Remover

Device: Pixie® skin tag

Study type

Interventional

Funder types

Industry

Identifiers

NCT06315946

17E3241

Details and patient eligibility

About

Evaluate the efficacy of the test medical device (Pixie® skin tag) in the treatment of skin tags versus a comparator product (Wortie® skin tag remover).

Full description

The main objective of the study was to evaluate the efficacy of the test medical device Pixie® skin tag) in the treatment of skin tags versus a comparator product (Wortie® skin tag remover). Non-inferiority of the test product versus competitor on skin tag evaluated by clinical evaluation.

The secondary objectives of the study were to evaluate:

the number of treatments needed for the complete disappearance of skin tag;
the efficacy of devices by subjects' self-assessment;
the cutaneous tolerability (safety).

The last objective of the study was to illustrate the expected visual effects.

Enrollment

56 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.