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

NCT ID: NCT05115669

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2022-05-01

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.

Conditions

Common Wart; Plantar Wart

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Wortie freeze plus

Cryogenic medical device (dimethylether-based product) + conductive gel + protective foam plasters.

Up to 3 applications one every 14 days

Group Type: EXPERIMENTAL

Wortie freeze plus

Intervention Type: DEVICE

treatment of common and plantar warts

Interventions

Wortie freeze plus

treatment of common and plantar warts

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karo Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agnieszka Cegielska, MD

Role: PRINCIPAL_INVESTIGATOR

Dermascan

Locations

Eurofins Dermascan Poland

Gdansk, , Poland

Countries

Poland

Other Identifiers

21E1573/WFP_001

Identifier Type: -

Identifier Source: org_study_id