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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wortie freeze plus | Experimental | Cryogenic medical device (dimethylether-based product) + conductive gel + protective foam plasters. Up to 3 applications one every 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wortie freeze plus | Device | treatment of common and plantar warts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with cured wart after maximun 3 treatments evaluate by the investigator | Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agnieszka Cegielska, MD | Dermascan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Dermascan Poland | Gdansk | Poland |
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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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| Day 14, Day 28, Day 42 |
| Mean frostbite area diameter after each treatment | Day 0, Day 14, Day 28 |
| Percentage of subjects satisfied with the treatment by answering a questionnaire at the study end | Day 14, Day 28, Day 42 |
| Illustration of the skin aspect by pictures before and after each treatment | 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 | 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 | Day 14,Day 28, Day 42 |
| Collection of adverse events throughout the study | Day 0, Day 14, Day 28, Day 42 |
| D017193 |
| Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |