Evaluate the Effectiveness and the Safety of a Medical Device in the Treatment of Common Warts and Plantar Warts.
Warts · Plantar Wart · Common Wart
Bottom Line
View on ClinicalTrials.gov: NCT06214559 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sérum VERRUPRO (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Swiss Footcare Laboratories - Poderm Professional
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diameter of the Wart |
-0.12 | — |
| SECONDARY Global Improvement of the Wart |
15; 12; 4; 1 | — |
| SECONDARY Roughness of the Wart |
-1.4 | — |
| SECONDARY Thickness of the Wart |
-1.5 | — |
| SECONDARY Number of Dermal Papillae |
-4.1 | — |
| SECONDARY Number of Participants Who Participated in Photography Session |
32 | — |
| SECONDARY Patient Evaluation |
8; 9; 11; 4; 0 | — |
| SECONDARY Adverse Event |
— | — |
| SECONDARY Product Tolerance |
18; 9; 3; 1; 1 | — |
Summary
Eligibility Criteria
Inclusion Criteria
Patient having given freely her/his informed, written consent. Patient having a good general health. Age: more than 18 years. Patient cooperative and aware of the device's modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
Patient being psychologically able to understand information and to give his/her consent.
Patient presenting at least 1 common wart, present since less than 6 months, on the fingers, back of the hands (60% of patients) and/or at least 1 plantar wart (40% of patients).
Patient presenting wart of a size between 0,1 and 0,5 cm. Women of childbearing potential should use an accepted contraceptive regimen (at the Investigator's discretion) since at least 12 weeks before the beginning of the study and during all the study.
Exclusion Criteria
For plantar wart: wart on the point of support. Wart with keratosis. Wart in mosaic. Pregnant or nursing woman or planning a pregnancy during the investigation. Patient considered by the investigator likely to be non-compliant with the protocol.
Patient enrolled in another clinical trial during the test period. Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.
Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.
Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, immunocompromised patient HIV, psoriasis, lichen planus, immunosuppressive pathology, chronic venous insufficiency, Peripheral Arterial Obstructive Disease, delay or lack of ungual growth … Patient with cutaneous pathology on studied zone other than warts.
Data sourced from ClinicalTrials.gov (NCT06214559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.