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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
138
Treatment of common and plantar wart by cryotherapy treatment.
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)
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.
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)
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
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.
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)
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.
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Time frame: After 1 treatment (day 15), after 2 treatments (day 29), after 3 treatments (day 45)