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

NCT05115669 | Completed

• 1 other identifier: 21E1573/WFP_001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  Day 42

Secondary Outcomes (8)

• 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 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

• 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

Study Arms (1)

Wortie freeze plus

EXPERIMENTAL

Cryogenic medical device (dimethylether-based product) + conductive gel + protective foam plasters. Up to 3 applications one every 14 days

Device: Wortie freeze plus

Interventions

Wortie freeze plus DEVICE

treatment of common and plantar warts

Wortie freeze plus

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Subject with immune deficiency or autoimmune disease.
• Subject presenting more than 10 warts on the body
• Subject presenting bleeding warts.
• Subject presenting birthmarks, moles, warts with hairs growing from them, or any other spots on the treated and surrounding area.
• Subject having a sensitive, inflamed, infected, irritated, red, damaged, cut, grazed, diseased or itchy skin on or around the treated zone.

Sponsors & Collaborators

• Karo Pharma AB: lead

Study Sites (1)

Eurofins Dermascan Poland

Gdansk, Poland

Location

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Agnieszka Cegielska, MD

  Dermascan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 10, 2021
• Study Start: October 12, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)