WartsNCT03129373
Clinical Study : Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment
A study testing Cryogenic treatment of warts in people with Warts, run by Oystershell NV.
Trial summary
The present study was set-up to evaluate clinical efficacy of Pixie® cryogenic pen versus two comparator cryogenic products (Wartner® and Wortie®) for the treatment of common and plantar warts. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Warts
- What is being tested?
- Cryogenic treatment of warts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Nov 2016
- 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy subject.
- Sex: male or female.
- Age: more than 4 years old.
- Subject presenting at least 1 new common wart on hand or on feet or plantar wart (wart present since less than 6 months).
- Subject, including minors aged more than 14 years, having given freely and expressly his/her informed consent.
- Minor whose legal guardians have given their free and express informed consent.
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- Subject who is able to comply with the study requirements, as defined in the present protocol, at the Investigator's appreciation.
- Subject able to comply with protocol requirements, as defined in the protocol.
- Subject or child's legal guardians being affiliated to a health social security system.
- Female subjects 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.
Who cannot join
- 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.
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- 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.
- 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 undergoing a topical treatment on the test area or a systemic treatment:
- 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.
- Subjects must not take part in any other clinical study whilst taking part in this study.
- Subjects must not deliberately "sunbathe" for the duration of the study on the studied zone in case they cannot cover the treated area from sunlight.
- No product (except usual hygiene products and except for the prescribed after treatment) is to be used on the selected wart during the study. The subjects will continue to use their usual hygiene products, but they must not change the brand or use new products throughout the course of the study.
About this study
Official title: Clinical Trial to Demonstrate the Comparative Efficacy of a Cryogenic Treatment (Medical Device) In Common and Plantar Warts Management
The present study was set-up to evaluate clinical efficacy of Pixie® cryogenic pen versus two comparator cryogenic products (Wartner® and Wortie®) for the treatment of common and plantar warts.
Read the detailed description
The use of cryotherapy has been long known to be effective against warts. The indications for Pixie® are in line with the indications presented in the collected literature data, as well as with the indications of equivalent devices.
The benefits of warts treatment without the use of chemicals are clearly evidenced. The treatment period is much shorter (one treatment compared to daily application of keratinolytics or fluorouracil, over a period of a few weeks). The cryogen therapy application through a conic tip is much more precise than with 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
- Conditions
- Warts
- Being tested
- Cryogenic treatment of warts
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryogenic treatment of wartsDevice
Treatment of common and plantar wart by cryotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Pixie group | Experimental | Cryogenic treatment of wart (liquified nitrous oxide)
* Maximum 3 application by the technician in charge of the study.
* Apply between 15 to 20 sec on hand and 40 sec on feet. Receives: Device: Cryogenic treatment of warts |
| Wartner group | Active comparator | Cryogenic treatment of wart (dimethylether propane-based):
* Maximum 3 application by the technician in charge of the study.
* Apply between 15 to 20 sec on hand and 40 sec on feet. Receives: Device: Cryogenic treatment of warts |
| Wortie group | Active comparator | Cryogenic treatment of wart (dimethylether-based product):
* Maximum 3 application by the technician in charge of the study.
* Apply between 15 to 20 sec on hand and 40 sec on feet. Receives: Device: Cryogenic treatment of warts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the percentage of subjects with clinical wart remission after 1 treatment in the Pixie® group versus comparators groups (Wartner® and Wortie®), as observed during a clinical evaluation of the treated wart by the dermatologist.
Measured: After 1 treatment (approximately 15 days after the first treatment)
Secondary outcomes (6)
Comparison of the number of treatments needed for clinical remission of warts with the three products.
Measured: 1 treatment (day 0), 2 treatments (day 15), 3 treatments (day 29)
Surface area measurements of frostbite area to evaluate the efficacy of the freezing process, during the three applications if applicable.
Measurement immediately after treatment, with a tape measure device of the frostbite on the skin, created by cryothereapy treatment (measure in cm)
Measured: 1 treatment (day 0), 2 treatments (day 15), 3 treatments (day 29)
Illustration of the visual aspects of the wart remission with macrophotographs.
Macrophotographs taken with a Nikon D90 apparatus and a standardization device for the repositionning
Measured: Before treatment (day 0 before treatment), after 1 treatment (day 15), after 2 treatments (day 29), after 3 treatments (day 45)
Evaluation of the skin conditions at study end, assessed by the investigator by clinical evaluation.
Evaluation of the skin color after treatment.
Measured: Before treatment (day 0 before treatment), after 1 treatment (day 15), after 2 treatments (day 29), after 3 treatments (day 45)
Recording of adverse events.
Measured: On days 0, 3, 15, 29 and 45
Comparison of the percentage of subjects with clinical wart remission after 1, 2 and 3 treatments in the Pixie® group versus comparators groups (Wartner® and Wortie®), as observed during a clinical evaluation of the treated wart by the dermatologist.
Measured: After 1 treatment (day 15), after 2 treatments (day 29), after 3 treatments (day 45)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study startJul 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WartsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oystershell NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129373
- Sponsor's protocol ID
- 14E2344
- Status last verified
- Sep 2017
- First submitted
- 3 Apr 2017
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walczuk I, Eertmans F, Rossel B, Cegielska A, Stockfleth E, Antunes A, Adriaens E. Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment: A Randomized, Controlled, Investigator-Blinded, Comparative Study. Dermatol Ther (Heidelb). 2018 Jun;8(2):203-216. doi: 10.1007/s13555-017-0210-5. Epub 2017 Dec 6.
PubMed 29214505
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Demonstrate the Comparative Efficacy of a Cryogenic Treatment (Medical Device) In Common and Plantar Warts Management
- ClinicalTrials.gov ID
- NCT03129373
- Acronym / sponsor ID
- 14E2344
- Conditions
- Warts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Oystershell NVIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 26 Apr 2017 (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.
The present study was set-up to evaluate clinical efficacy of Pixie® cryogenic pen versus two comparator cryogenic products (Wartner® and 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® are in line with the indications presented in the collected literature data, as well as with the indications of equivalent devices.
The benefits of warts treatment without the use of chemicals are clearly evidenced. The treatment period is much shorter (one treatment compared to daily application of keratinolytics or fluorouracil, over a period of a few weeks). The cryogen therapy application through a conic tip is much more precise than with 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pixie group | Experimental | Device: Cryogenic treatment of wartsCryogenic treatment of wart (liquified nitrous oxide) * Maximum 3 application by the technician in charge of the study. * Apply between 15 to 20 sec on hand and 40 sec on feet. |
| Wartner group | Active comparator | Device: Cryogenic treatment of wartsCryogenic treatment of wart (dimethylether propane-based): * Maximum 3 application by the technician in charge of the study. * Apply between 15 to 20 sec on hand and 40 sec on feet. |
| Wortie group | Active comparator | Device: Cryogenic treatment of wartsCryogenic treatment of wart (dimethylether-based product): * Maximum 3 application by the technician in charge of the study. * Apply between 15 to 20 sec on hand and 40 sec on feet. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy subject.
- Sex: male or female.
- Age: more than 4 years old.
- Subject presenting at least 1 new common wart on hand or on feet or plantar wart (wart present since less than 6 months).
- Subject, including minors aged more than 14 years, having given freely and expressly his/her informed consent.
Key exclusion criteria (26 listed)
- 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.
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 |
|---|---|---|
| Cryogenic treatment of wartsTreatment of common and plantar wart by cryotherapy treatment. | Device | Pixie group, Wartner group, Wortie group |
Primary outcome
Comparison of the percentage of subjects with clinical wart remission after 1 treatment in the Pixie® group versus comparators groups (Wartner® and Wortie®), as observed during a clinical evaluation of the treated wart by the dermatologist.
Time frame: After 1 treatment (approximately 15 days after the first treatment)
6 secondary outcomes
Comparison of the number of treatments needed for clinical remission of warts with the three products.
Time frame: 1 treatment (day 0), 2 treatments (day 15), 3 treatments (day 29)
Surface area measurements of frostbite area to evaluate the efficacy of the freezing process, during the three applications if applicable.
Time frame: 1 treatment (day 0), 2 treatments (day 15), 3 treatments (day 29)
Illustration of the visual aspects of the wart remission with macrophotographs.
Time frame: Before treatment (day 0 before treatment), after 1 treatment (day 15), after 2 treatments (day 29), after 3 treatments (day 45)
Evaluation of the skin conditions at study end, assessed by the investigator by clinical evaluation.
Time frame: Before treatment (day 0 before treatment), after 1 treatment (day 15), after 2 treatments (day 29), after 3 treatments (day 45)
Recording of adverse events.
Time frame: On days 0, 3, 15, 29 and 45
Comparison of the percentage of subjects with clinical wart remission after 1, 2 and 3 treatments in the Pixie® group versus comparators groups (Wartner® and Wortie®), as observed during a clinical evaluation of the treated wart by the dermatologist.
Time frame: After 1 treatment (day 15), after 2 treatments (day 29), after 3 treatments (day 45)
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 19 Sep 2017.
- Derived from this study: PubMed 29214505Walczuk I, Eertmans F, Rossel B, Cegielska A, Stockfleth E, Antunes A, Adriaens E. Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment: A Randomized, Controlled, Investigator-Blinded, Comparative Study. Dermatol Ther (Heidelb). 2018 Jun;8(2):203-216. doi: 10.1007/s13555-017-0210-5. Epub 2017 Dec 6.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cryogenic treatment of warts in people with Warts, run by Oystershell NV.
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 10 inclusion and 26 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 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison of the percentage of subjects with clinical wart remission after 1 treatment in the Pixie® group versus comparators groups (Wartner® and Wortie®), as observed during a clinical evaluation of the treated wart by the dermatologist. (time frame: After 1 treatment (approximately 15 days after the first treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03129373, which also lists 1 linked publication.
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 19 Sep 2017.