Clinical Trial to Evaluate Efficacy and Safety of a Cryogenic Medical Device for Treatment of Com… (NCT06309420) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial to Evaluate Efficacy and Safety of a Cryogenic Medical Device for Treatment of Common and Plantar Warts
Poland54 participantsStarted 2019-11-07
Plain-language summary
The present study was set-up to evaluate clinical efficacy of Pixie CO2 versus a comparator product (Wortie®) for the treatment of common and plantar warts.
Who can participate
Age range4 Years
SexALL
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Inclusion Criteria:
* Healthy subject.
* Sex: male or female.
* Age: more than 4 years old.
* Subject presenting at least 1 new common wart on hand or a plantar wart (wart present since less than 6 months) of a size less than 0.8cm.
* Subject, including minors aged more than 16 years, having given freely and expressly his/her informed consent.
* Minor whose legal guardians have given their free and express informed consent.
* Subject who is able to comply with the study requirements, as defined in the present rotocol, at the Investigator's appreciation.
* Subject or child's legal guardians being affiliated to a health social security system.
* Female subject of childbearing potential should use a medically accepted contraceptive regimen (at the Investigator's discretion) since at least 12 weeks before the beginning of the study, during all the study.
Exclusion Criteria:
* Pregnant, parturient, or nursing woman or planning a pregnancy during the study.
* Subject who had been deprived of their freedom by administrative or legal decision.
* Subject in a social or sanitary establishment.
* Major subject who is under guardianship or who is not able to express his consent.
* 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 and plantar warts, on the studied z…
What they're measuring
1
Percentage of subjects with clinical wart remission