Clinical trial NCT06309420: Clinical Trial to Evaluate Efficacy and Safety of a Cryogenic Medical Device for Treatment of Common and Plantar Warts
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Warts
Lead sponsor: Oystershell NV
Sponsor class: INDUSTRY
First posted: 2024-03-13
Enrollment: 54
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigator-blinded, Randomized,Tested product versus comparator (benchmark product), In parallel groups, With multiple applications, Single centre.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of subjects with clinical wart remission
timeFrame: 1 treatment (Day 0), 2 treatments (Day 15), 3 treatments (Day 30)
Secondary outcomes:
measure: Number of treatments
timeFrame: 1 treatment (Day 0), 2 treatments (Day 15), 3 treatments (Day 30)
measure: Efficacy of the freezing process (Surface Area)
timeFrame: Measurement treatment 1 (Day 0), Measurement treatment 2 (Day 15), Measurement treatment 3 (Day 30)
measure: Diameter of the wart
timeFrame: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
measure: Roughness of the wart
timeFrame: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
measure: Thickness of the wart (For common warts only)
timeFrame: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
measure: Presence of small dark spot (For plantar warts only)
timeFrame: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
measure: Healing process of the wart
timeFrame: After 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
measure: Local & general tolerance
timeFrame: When wart is considered cured at Day 15, Day 30 or Day 45 or at the end of study on Day 45.
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Dermscan Poland
Study officials:
affiliation: ewaczek20@wp.pl
name: Ewa KARAMON
role: PRINCIPAL_INVESTIGATOR
References: