Safety & Effectiveness of Wortie Freeze Plus in Common and Plantar Warts

Inclusion criteria

• Healthy subjects.
• Sex: male or female.
• Age: 12 years old and above.
• Subjects presenting at least 1 common wart (present since less than 6 months) on the fingers or back of the hands, and/or plantar wart (40-60% subjects with common wart) of a size less than 1 cm.
• Subject, including minors having more than 12 years old, having given freely and expressly his/her informed consent.
• Minor whose legally designated representative have given their free and express informed consent.
• 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, during all the study and at least 1 month after the study end

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.
• Major subject who is under guardianship or who is not able to express his consent.
• Subject in a social or sanitary establishment.
• Subject suspected to be non-compliant according to the Investigator's judgment
• Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
• Subject with a cutaneous disease other than common warts, on the studied zone.
• Subject with a known allergy to one of the components of the investigational device or conductive gel.
• Subject who has diabetes.
• Subject having problems with blood circulation or having a blood clotting condition.
• Subject with immune deficiency or autoimmune disease.
• Subject presenting more than 10 warts on the body
• Subject presenting bleeding warts.
• Subject presenting birthmarks, moles, warts with hairs growing from them, or any other spots on the treated and surrounding area.
• Subject having a sensitive, inflamed, infected, irritated, red, damaged, cut, grazed, diseased or itchy skin on or around the treated zone.
• Subject presenting genital warts, flat warts, filiform warts, periungual warts or warts with hairs growing from them.
• Subject presenting 2 or more warts adjacent to each other
• Subject undergoing a topical treatment on the test area or a systemic treatment: anti-inflammatory medication and/or antihistamines during the 2 weeks prior to screening and during the study; or corticosteroids during the 2 weeks prior to screening and during the study; or retinoids and/or immunosuppressors during the 3 months prior to screening and during the study; or any medication stabilized for less than a month
• Subject who received a treatment of any type on the selected wart during the previous 6 months.
• Subject having started or changed her oral contraceptive or any other hormonal treatment during the three previous months
• Intensive exposure to sunlight or UV-rays on the studied zone within the previous month and/or foreseen during the study.
• Subject planning to change her/his life habits during the study.
• Subject with excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).