ISRCTN39469406
Completed
Phase 3
Clinical evaluation of the efficacy and safety of Excilor 2-in-1 Wart Treatment in the treatment of verruca vulgaris and verruca plantaris
Medical Brands0 sites66 target enrollmentJuly 27, 2022
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medical Brands
- Enrollment
- 66
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Sex: female and/or male
- •2\. Age: 45 adults 18\-65 years old (inclusive) and 15 children 4\-17 years old (inclusive)
- •3\. Subjects with at least one selected wart on the hand or foot not older than 1 year and not previously treated and having a diameter of 2 to 5 mm
- •4\. Subjects or parents/legal guardians psychologically able to understand the study\-related information and to give a written informed consent
- •5\. Subjects or parents/legal guardians have given freely and expressly their informed consent
- •6\. Subjects or parents/legal guardians able to comply with protocol requirements, as defined in the protocol
- •7\. Females of childbearing potential should use a medically accepted contraceptive regimen from at least 12 weeks before the beginning of the study till at least 1 month after study completion
Exclusion Criteria
- •Population:
- •1\. Pregnant or nursing subject or planning a pregnancy during the study (females only)
- •2\. Subject who had been deprived of her/his freedom by administrative or legal decision or who is under guardianship
- •3\. A subject in a social or sanitary establishment
- •4\. A subject in an emergency situation
- •5\. A subject suspected to be non\-compliant according to the investigator’s judgement
- •Associated pathology:
- •1\. A subject having clinically significant dermatological pathologies on the tested area, according to the investigator’s judgment
- •2\. A subject suffering from a clinically significant illness, stabilized or evolutionary, according to the investigator’s judgement
- •3\. Subjects who are suffering from diabetic and/or have a poor blood circulation
Outcomes
Primary Outcomes
Not specified
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