Clinical evaluation of the safety and effectiveness of Excilor 2-in-1 Wart Treatment in the treatment of warts on the hands and feet

Phase 3

Completed

• Conditions: Verruca vulgaris and verruca plantaris; Infections and Infestations; Viral warts

• Registration Number: ISRCTN39469406
• Lead Sponsor: Medical Brands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-09-06
• Study Start: 2022-07-27
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

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
4. Subjects presenting skin tags, moles, dark patches of skin, freckles, water warts (mollusca contagiosa), seborrhoeic keratosis (verruca seborrhoica) or exfoliated skin in the to be tested skin area
5. Damaged, open and/or inflamed skin in the treated area
6. Subjects with a known allergy or sensitivity to one of the products’ components
7. Immunosuppressed subjects

Previous or ongoing treatment:
1. Any treatment which, in the investigator’s judgement, put the patient at undue risk or may interfere with the evaluation of the study results

Lifestyle:
1. Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during or within 4-6 weeks after the study
2. A patient planning to change her/his life habits during the study (diet, cosmetic products use, sport activity etc)

Study & Design

• Study Type: Interventional
• Study Design: Not specified