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

Plantar Wart Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05115669
• Other study ID #: 21E1573/WFP_001
• Status: Completed
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: February 2023
• Source: Karo Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Healthy subjects.

2. Sex: male or female.

3. Age: 12 years old and above.

4. 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.

5. Subject, including minors having more than 12 years old, having given freely and expressly his/her informed consent.

6. Minor whose legally designated representative have given their free and express informed consent.

7. Subject affiliated to a health social security system.

8. 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:

1. Pregnant or nursing woman or planning a pregnancy during the study.

2. Subject who had been deprived of their freedom by administrative or legal decision.

3. Major subject who is under guardianship or who is not able to express his consent.

4. Subject in a social or sanitary establishment.

5. Subject suspected to be non-compliant according to the Investigator's judgment

6. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.

7. Subject with a cutaneous disease other than common warts, on the studied zone.

8. Subject with a known allergy to one of the components of the investigational device or conductive gel.

9. Subject who has diabetes.

10. Subject having problems with blood circulation or having a blood clotting condition.

11. Subject with immune deficiency or autoimmune disease.

12. Subject presenting more than 10 warts on the body

13. Subject presenting bleeding warts.

14. Subject presenting birthmarks, moles, warts with hairs growing from them, or any other spots on the treated and surrounding area.

15. Subject having a sensitive, inflamed, infected, irritated, red, damaged, cut, grazed, diseased or itchy skin on or around the treated zone.

16. Subject presenting genital warts, flat warts, filiform warts, periungual warts or warts with hairs growing from them.

17. Subject presenting 2 or more warts adjacent to each other

18. 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

19. Subject who received a treatment of any type on the selected wart during the previous 6 months.

20. Subject having started or changed her oral contraceptive or any other hormonal treatment during the three previous months

21. Intensive exposure to sunlight or UV-rays on the studied zone within the previous month and/or foreseen during the study.

22. Subject planning to change her/his life habits during the study.

23. Subject with excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).

Related Conditions & MeSH terms

• Common Wart
• Foot Diseases
• Plantar Wart
• Warts

Intervention

Device:
• Wortie freeze plus
treatment of common and plantar warts

Locations

Country	Name	City	State
Poland	Eurofins Dermascan Poland	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Karo Pharma AB

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with cured wart after maximun 3 treatments evaluate by the investigator		Day 42
Secondary	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
Secondary	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
Secondary	Mean frostbite area diameter after each treatment		Day 0, Day 14, Day 28
Secondary	Percentage of subjects satisfied with the treatment by answering a questionnaire at the study end		Day 14, Day 28, Day 42
Secondary	Illustration of the skin aspect by pictures before and after each treatment		Day 0, Day 14, Day 28
Secondary	Mean subject' pain during treatment evaluated using a using a 11-item (0-10) Numerical Rating Scale	0= no pain; 10= worst possible pain	Day 0, Day 14, Day 28
Secondary	Subject tolerability evaluated at the study end by the investigator using a 4-item (0-3) Numerical scale	0=bad tolerance; 1= moderate tolerance; 2= good tolerance; 3 = very good tolerance	Day 14,Day 28, Day 42
Secondary	Collection of adverse events throughout the study		Day 0, Day 14, Day 28, Day 42