CompletedNot Applicable

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

Poland50 participantsStarted 2021-10-12

Plain-language summary

This is a Post-Market clinical Follow-up investigation to evaluate the safety and performed of the medical device Wortie Freeze Plus in the treatment of common and plantar warts.

Who can participate

Age range12 Years

SexALL

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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.

What they're measuring

Percentage of subjects with cured wart after maximun 3 treatments evaluate by the investigator

Timeframe: Day 42

Trial details

NCT IDNCT05115669

SponsorKaro Pharma AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-01

View on ClinicalTrials.gov More Common Wart trials