Common WartNCT05115669
Safety & Effectiveness of Wortie Freeze Plus in Common and Plantar Warts
A study testing Wortie freeze plus in people with Common Wart and Plantar Wart, run by Karo Pharma AB at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Common Wart, Plantar Wart
- What is being tested?
- Wortie freeze plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 12 Oct 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
- Subject presenting genital warts, flat warts, filiform warts, periungual warts or warts with hairs growing from them.
- 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 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
- Subject who received a treatment of any type on the selected wart during the previous 6 months.
- Subject having started or changed her oral contraceptive or any other hormonal treatment during the three previous 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.
- Subject with excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Open Clinical Investigation to Evaluate the Effectiveness and Safety of Wortie® Freeze Plus in the Treatment of Common Warts and Plantar Warts
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
- Being tested
- Wortie freeze plus
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wortie freeze plusDevice
treatment of common and plantar warts
| Study group | Role | What they receive |
|---|---|---|
| Wortie freeze plus | Experimental | Cryogenic medical device (dimethylether-based product) + conductive gel + protective foam plasters.
Up to 3 applications one every 14 days Receives: Device: Wortie freeze plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with cured wart after maximun 3 treatments evaluate by the investigator
Measured: 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
Measured: 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
Measured: Day 14, Day 28, Day 42
Mean frostbite area diameter after each treatment
Measured: Day 0, Day 14, Day 28
Percentage of subjects satisfied with the treatment by answering a questionnaire at the study end
Measured: Day 14, Day 28, Day 42
Illustration of the skin aspect by pictures before and after each treatment
Measured: Day 0, Day 14, Day 28
Mean subject' pain during treatment evaluated using a using a 11-item (0-10) Numerical Rating Scale
0= no pain; 10= worst possible pain
Measured: Day 0, Day 14, Day 28
Subject tolerability evaluated at the study end by the investigator using a 4-item (0-3) Numerical scale
0=bad tolerance; 1= moderate tolerance; 2= good tolerance; 3 = very good tolerance
Measured: Day 14,Day 28, Day 42
Collection of adverse events throughout the study
Measured: Day 0, Day 14, Day 28, Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start12 Oct 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common WartStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karo Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Agnieszka Cegielska, MD, Principal investigator, Dermascan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115669
- Sponsor's protocol ID
- 21E1573/WFP_001
- Status last verified
- Feb 2023
- First submitted
- 15 Oct 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open Clinical Investigation to Evaluate the Effectiveness and Safety of Wortie® Freeze Plus in the Treatment of Common Warts and Plantar Warts
- ClinicalTrials.gov ID
- NCT05115669
- Acronym / sponsor ID
- 21E1573/WFP_001
- Conditions
- Common Wart, Plantar Wart
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Karo Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wortie freeze plus | Experimental | Device: Wortie freeze plusCryogenic medical device (dimethylether-based product) + conductive gel + protective foam plasters. Up to 3 applications one every 14 days |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wortie freeze plustreatment of common and plantar warts | Device | Wortie freeze plus |
Primary outcome
Percentage of subjects with cured wart after maximun 3 treatments evaluate by the investigator
Time frame: Day 42
8 secondary outcomes
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
Time frame: 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
Time frame: Day 14, Day 28, Day 42
Mean frostbite area diameter after each treatment
Time frame: Day 0, Day 14, Day 28
Percentage of subjects satisfied with the treatment by answering a questionnaire at the study end
Time frame: Day 14, Day 28, Day 42
Illustration of the skin aspect by pictures before and after each treatment
Time frame: Day 0, Day 14, Day 28
Mean subject' pain during treatment evaluated using a using a 11-item (0-10) Numerical Rating Scale
Time frame: Day 0, Day 14, Day 28
Subject tolerability evaluated at the study end by the investigator using a 4-item (0-3) Numerical scale
Time frame: Day 14,Day 28, Day 42
Collection of adverse events throughout the study
Time frame: Day 0, Day 14, Day 28, Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Cegielska, MD principal investigator
Dermascan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wortie freeze plus in people with Common Wart and Plantar Wart, run by Karo Pharma AB at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with cured wart after maximun 3 treatments evaluate by the investigator (time frame: Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.