Back to resultsClinical Study : Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment
Primary Purpose
Warts
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cryogenic treatment of warts
Sponsored by
About this trial
This is an interventional treatment trial for Warts
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 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.
- 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.
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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Pixie group
Wartner group
Wortie group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Comparison of the number of treatments needed for clinical remission of warts with the three products.
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)
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
Evaluation of the skin conditions at study end, assessed by the investigator by clinical evaluation.
Evaluation of the skin color after treatment.
Recording of adverse events.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03129373
Brief Title
Clinical Study : Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment
Official Title
Clinical Trial to Demonstrate the Comparative Efficacy of a Cryogenic Treatment (Medical Device) In Common and Plantar Warts Management
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oystershell NV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warts
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pixie group
Arm Type
Experimental
Arm Description
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.
Arm Title
Wartner group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Wortie group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cryogenic treatment of warts
Intervention Description
Treatment of common and plantar wart by cryotherapy treatment.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)
Title
Surface area measurements of frostbite area to evaluate the efficacy of the freezing process, during the three applications if applicable.
Description
Measurement immediately after treatment, with a tape measure device of the frostbite on the skin, created by cryothereapy treatment (measure in cm)
Time Frame
1 treatment (day 0), 2 treatments (day 15), 3 treatments (day 29)
Title
Illustration of the visual aspects of the wart remission with macrophotographs.
Description
Macrophotographs taken with a Nikon D90 apparatus and a standardization device for the repositionning
Time Frame
Before treatment (day 0 before treatment), after 1 treatment (day 15), after 2 treatments (day 29), after 3 treatments (day 45)
Title
Evaluation of the skin conditions at study end, assessed by the investigator by clinical evaluation.
Description
Evaluation of the skin color after treatment.
Time Frame
Before treatment (day 0 before treatment), after 1 treatment (day 15), after 2 treatments (day 29), after 3 treatments (day 45)
Title
Recording of adverse events.
Time Frame
On days 0, 3, 15, 29 and 45
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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.
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.
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.
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29214505
Citation
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.
Results Reference
derived
Learn more about this trial
Clinical Study : Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment
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