Clinical Trial to Evaluate Efficacy and Safety of a Cryogenic Medical Device for Treatment of Common and Plantar Warts

NCT06309420 | Completed

• 1 other identifier: 19E0566
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Warts

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with clinical wart remission

  Comparison of the percentage of subjects with clinical wart remission after 1, 2 and 3 treatments with the tested product group versus comparator group, as observed during clinical evaluation of the treated wart by a dermatologist.

  1 treatment (Day 0), 2 treatments (Day 15), 3 treatments (Day 30)

Secondary Outcomes (8)

• Number of treatments

  1 treatment (Day 0), 2 treatments (Day 15), 3 treatments (Day 30)

• Efficacy of the freezing process (Surface Area)

  Measurement treatment 1 (Day 0), Measurement treatment 2 (Day 15), Measurement treatment 3 (Day 30)

• Diameter of the wart

  Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)

• Roughness of the wart

  Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)

• Thickness of the wart (For common warts only)

  Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)

Study Arms (2)

Pixie CO2

EXPERIMENTAL

Cryogenic treatment of warts (Carbonic ice tablet) Maximum 3 application by the technician in charge of the study Apply 15 seconds for a wart on hand or arm and 40 seconds for a wart on feet or toe

Device: Cryogenic treatment of warts (Pixie CO2)

Wortie®

ACTIVE COMPARATOR

Cryogenic treatment of wart (dimethylether-based product) Maximum 3 application by the technician in charge of the study. Apply 20 seconds for a wart on hand or arm and 40 seconds for a wart on feet or toe

Device: Cryogenic treatment of warts (Wortie®)

Interventions

Cryogenic treatment of warts (Pixie CO2) DEVICE

Treatment of common and plantar warts by cryotherapy treatment.

Also known as: X92001686

Pixie CO2

Cryogenic treatment of warts (Wortie®) DEVICE

Treatment of common and plantar warts by cryotherapy treatment.

Wortie®

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 zone.
• Subject with a known allergy to one of the component of the products or to the comparator.
• 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 skin, inflamed, infected, irritated, red, damaged, cut, grazed, diseased or itchy on the treated zone.

Sponsors & Collaborators

• Oystershell NV: lead

Study Sites (1)

Dermscan Poland

Gdansk, 80-288, 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

• Ewa KARAMON

  ewaczek20@wp.pl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Investigator-blinded, Randomized,Tested product versus comparator (benchmark product), In parallel groups, With multiple applications, Single centre.

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: March 13, 2024
• Study Start: November 7, 2019
• Primary Completion: August 10, 2020
• Study Completion: August 10, 2020
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

PL (1)