This is a Post-Market clinical Follow-up investigation to evaluate the safety and performed of the medical device Wortie Freeze Plus in the treatment of common and plantar warts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
treatment of common and plantar warts
Eurofins Dermascan Poland
Gdansk, Poland
Percentage of subjects with cured wart after maximun 3 treatments evaluate by the investigator
Time frame: Day 42
Percentage of subjects with cured wart after 1, 2 and 3 treatments evaluated by the investigator common and plantar warts after 1, 2 and 3 treatments as assessed by the investigator
Time frame: Day 14, Day 28, Day 42
Percentage of subjects with improved aspect of the wart after 1, 2 and 3 treatments evaluated by the investigator
Time frame: Day 14, Day 28, Day 42
Mean frostbite area diameter after each treatment
Time frame: Day 0, Day 14, Day 28
Percentage of subjects satisfied with the treatment by answering a questionnaire at the study end
Time frame: Day 14, Day 28, Day 42
Illustration of the skin aspect by pictures before and after each treatment
Time frame: Day 0, Day 14, Day 28
Mean subject' pain during treatment evaluated using a using a 11-item (0-10) Numerical Rating Scale
0= no pain; 10= worst possible pain
Time frame: Day 0, Day 14, Day 28
Subject tolerability evaluated at the study end by the investigator using a 4-item (0-3) Numerical scale
0=bad tolerance; 1= moderate tolerance; 2= good tolerance; 3 = very good tolerance
Time frame: Day 14,Day 28, Day 42
Collection of adverse events throughout the study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 0, Day 14, Day 28, Day 42