The present study was set-up to evaluate clinical efficacy of Pixie CO2 versus a comparator product (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 CO2 are in line with the indications presented in the collected literature data, as well as with the indications of similar devices. The benefits of the use of cryotherapy for warts is clearly evidenced. The treatment period is short (up to 3 treatments with a 14 day interval, compared to daily application of keratinolytics or fluorouracil, over a period of weeks). The cryotherapy application through a conic applicator is much more precise than with most 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
SINGLE
Enrollment
54
Treatment of common and plantar warts by cryotherapy treatment.
Treatment of common and plantar warts by cryotherapy treatment.
Dermscan Poland
Gdansk, Poland
Percentage of subjects with clinical wart remission
Comparison of the percentage of subjects with clinical wart remission after 1, 2 and 3 treatments with the tested product group versus comparator group, as observed during clinical evaluation of the treated wart by a dermatologist.
Time frame: 1 treatment (Day 0), 2 treatments (Day 15), 3 treatments (Day 30)
Number of treatments
Comparison of the number of treatments needed for clinical remission of warts with both products
Time frame: 1 treatment (Day 0), 2 treatments (Day 15), 3 treatments (Day 30)
Efficacy of the freezing process (Surface Area)
Surface area measurements of frostbite area to evaluate the efficacy of the freezing process
Time frame: Measurement treatment 1 (Day 0), Measurement treatment 2 (Day 15), Measurement treatment 3 (Day 30)
Diameter of the wart
Macrophotography of the wart
Time frame: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Roughness of the wart
Evaluation of roughness of the wart by blinded dermatologist. Classification scheme was used: 0=absence, 1=light, 2=moderate, 3=severe, and 4=very severe
Time frame: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Thickness of the wart (For common warts only)
Evaluation of thickness of the wart by blinded dermatologist. Classification scheme was used: 0=absence, 1=light, 2=moderate, 3=severe, and 4=very severe
Time frame: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
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Presence of small dark spot (For plantar warts only)
Evaluation of presence of a small dark spot by blinded dermatologist. Classification scheme was used: 0=absence, 1=light, 2=moderate, 3=severe, and 4=very severe
Time frame: Before treatment Day 0, after 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Healing process of the wart
Evaluation of healing process of the wart by blinded dermatologist. This is done by assessing: * Discontinuation of skin lines (5 categories: 0=none, 1=light, 2=moderate, 3=severe, and 4=very severe) * Affection of skin color (5 categories: 0=none, 1=light, 2=moderate, 3=severe, and 4=very severe) * Presence/absence of a scab.
Time frame: After 1 treatment (Day 3 & Day 15), after 2 treatments (Day 30), after 3 treatments (Day 45)
Local & general tolerance
Evaluate the safety of the products by assessing local \& general tolerance. Local tolerance will be assessed by using the following scale (0= Bad tolerance, 1= Moderade tolerance, 2= Good tolerance, 3=Very good tolerance.) Abnormal clinical signs and subjective signs reported by the subjects will be reported in the CRF. The general tolerance is a collection of adverse events by the investigator.
Time frame: When wart is considered cured at Day 15, Day 30 or Day 45 or at the end of study on Day 45.