Prospective, Open Clinical Investigation to Evaluate the Effectiveness and Safety of Wortie® Freeze Plus in the Treatment of Common Warts and Plantar Warts

Karo Pharma AB1 site in 1 country50 target enrollmentOctober 12, 2021

ConditionsCommon Wart Plantar Wart

Overview

Phase: N/A
Intervention: Not specified
Conditions: Common Wart
Sponsor: Karo Pharma AB
Enrollment: 50
Locations: 1
Primary Endpoint: Percentage of subjects with cured wart after maximun 3 treatments evaluate by the investigator
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 12, 2021

End Date

May 1, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Karo Pharma AB

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: Day 42

Secondary Outcomes

Percentage of subjects with cured wart after 1, 2 and 3 treatments evaluated by the investigator common and plantar warts after 1, 2 and 3 treatments as assessed by the investigator(Day 14, Day 28, Day 42)
Percentage of subjects satisfied with the treatment by answering a questionnaire at the study end(Day 14, Day 28, Day 42)
Illustration of the skin aspect by pictures before and after each treatment(Day 0, Day 14, Day 28)
Mean subject' pain during treatment evaluated using a using a 11-item (0-10) Numerical Rating Scale(Day 0, Day 14, Day 28)
Percentage of subjects with improved aspect of the wart after 1, 2 and 3 treatments evaluated by the investigator(Day 14, Day 28, Day 42)
Mean frostbite area diameter after each treatment(Day 0, Day 14, Day 28)
Subject tolerability evaluated at the study end by the investigator using a 4-item (0-3) Numerical scale(Day 14,Day 28, Day 42)
Collection of adverse events throughout the study(Day 0, Day 14, Day 28, Day 42)