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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pixie group | Experimental | Cryogenic treatment of wart (liquified nitrous oxide)
|
|
| Wartner group | Active Comparator | Cryogenic treatment of wart (dimethylether propane-based):
|
|
| Wortie group | Active Comparator | Cryogenic treatment of wart (dimethylether-based product):
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryogenic treatment of warts | Device | Treatment of common and plantar wart by cryotherapy treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 1 treatment (approximately 15 days after the first treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the number of treatments needed for clinical remission of warts with the three products. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29214505 | Derived | 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. |
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| ID | Term |
|---|---|
| D014860 | Warts |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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Measurement immediately after treatment, with a tape measure device of the frostbite on the skin, created by cryothereapy treatment (measure in cm)
| 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 | 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. | 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. | 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. | After 1 treatment (day 15), after 2 treatments (day 29), after 3 treatments (day 45) |
| D017193 |
| Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |