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

Prospective, Single-blinded, Randomized Trial to Evaluate the Efficacy of a Cryogenic Medical Device in Treatment of Common and Plantar Warts Versus a Comparator Product.

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.

Study Overview

• Status: Completed
• Conditions: Warts
• Intervention / Treatment: Device: Cryogenic treatment of warts (Pixie CO2); Device: Cryogenic treatment of warts (Wortie®)

Detailed Description

The use of cryotherapy has been long known to be effective against warts. The indications for Pixie CO2 are in line with the indications presented in the collected literature data, as well as with the indications of similar devices.

The benefits of the use of cryotherapy for warts is clearly evidenced. The treatment period is short (up to 3 treatments with a 14 day interval, compared to daily application of keratinolytics or fluorouracil, over a period of weeks). The cryotherapy application through a conic applicator is much more precise than with most chemical substances. Chemical substance application is leading to more side effects of the surrounding skin (typical for chemical treatment are pain, blistering, ulceration and contact dermatitis).

The Instructions for Use were developed in line with these data and are therefore covering all hazards known up to the date of this report.

Based on these data the product received its CE-mark approval.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Gdansk, Poland, 80-288
    • Dermscan Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Subject presenting genital warts, flat warts, filiform warts, periungual warts or warts larger than 0.8cm.
• Subject presenting 2 or more warts adjacent to each other.
• Subject undergoing a topical treatment on the test area or a systemic treatment:
• anti-inflammatory medication during the previous 2 weeks and during the study,
• immunosuppressors and/or corticoids during the 4 previous weeks and during the study,
• retinoids during the 6 previous months and during the study,
• any medication stabilized for less than one month.
• Subject who received a treatment of any type on the selected wart during the previous 6 months.
• Intensive exposure to sunlight or UV-rays on the studied zone within the previous month and/or foreseen during the study.
• Subject planning to change her/his life habits during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pixie CO2; 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); Treatment of common and plantar warts by cryotherapy treatment.; Other Names: X92001686
Active Comparator: Wortie®; 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®); Treatment of common and plantar warts by cryotherapy treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatments	Comparison of the number of treatments needed for clinical remission of warts with both products	1 treatment (Day 0), 2 treatments (Day 15), 3 treatments (Day 30)
Efficacy of the freezing process (Surface Area)	Surface area measurements of frostbite area to evaluate the efficacy of the freezing process	Measurement treatment 1 (Day 0), Measurement treatment 2 (Day 15), Measurement treatment 3 (Day 30)
Diameter of the wart	Macrophotography 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	Evaluation of roughness of the wart by blinded dermatologist. Classification scheme was used: 0=absence, 1=light, 2=moderate, 3=severe, and 4=very severe	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)	Evaluation of thickness of the wart by blinded dermatologist. Classification scheme was used: 0=absence, 1=light, 2=moderate, 3=severe, and 4=very severe	Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Presence of small dark spot (For plantar warts only)	Evaluation of presence of a small dark spot by blinded dermatologist. Classification scheme was used: 0=absence, 1=light, 2=moderate, 3=severe, and 4=very severe	Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Healing process of the wart	Evaluation of healing process of the wart by blinded dermatologist. This is done by assessing: Discontinuation of skin lines (5 categories: 0=none, 1=light, 2=moderate, 3=severe, and 4=very severe); Affection of skin color (5 categories: 0=none, 1=light, 2=moderate, 3=severe, and 4=very severe); Presence/absence of a scab.	After 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Local & general tolerance	Evaluate the safety of the products by assessing local & general tolerance. Local tolerance will be assessed by using the following scale (0= Bad tolerance, 1= Moderade tolerance, 2= Good tolerance, 3=Very good tolerance.) Abnormal clinical signs and subjective signs reported by the subjects will be reported in the CRF. The general tolerance is a collection of adverse events by the investigator.	When wart is considered cured at Day 15, Day 30 or Day 45 or at the end of study on Day 45.

Collaborators and Investigators

• Sponsor: Oystershell NV
• Investigators: Principal Investigator: Ewa KARAMON, ewaczek20@wp.pl

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2019
• Primary Completion (Actual): August 10, 2020
• Study Completion (Actual): August 10, 2020

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts
• Other Study ID Numbers: 19E0566

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No