INTERFERON ALFA, INTERLEUKIN-1, INTERLEUKIN-2, RIBONUCLEIC ACID, SPECIFIC NUCLEIC ACID SNA-HLA II, SPECIFIC NUCLEIC ACID SNA-VERU for Non-genital warts | Common warts | Plantar warts | Flat warts

Inclusion criteria

• {"criterion_text":"- Patients, male or female, aged 3 years and older,"}
• {"criterion_text":"- Patients with common warts (Verruca vulgaris), and/or plantar warts (Verruca plantaris), and/or flat warts (Verruca plana),"}
• {"criterion_text":"- Patients (and/or parents if necessary) having the faculties to understand and respect the constraints of the study,"}
• {"criterion_text":"- Signature of the Informed Consent Form by the patient (and/or parents if necessary)."}

Exclusion criteria

• {"criterion_text":"- Patients who have received any curative warts treatment in the previous 2 months prior to the study,"}
• {"criterion_text":"- Patients who have received any homeopathic treatment in the previous 2 months prior to the study,"}
• {"criterion_text":"- Patients under immunosuppressive treatment,"}
• {"criterion_text":"- Patients having received immunotherapy or micro-immunotherapy during the last 6 months,"}
• {"criterion_text":"- Patients with known lactose intolerance,"}
• {"criterion_text":"- Pregnant or breastfeeding women,"}
• {"criterion_text":"- Patients who participated in a clinical study in the previous 2-months period,"}
• {"criterion_text":"- Patients (and/or parents of patients if necessary) who are not sufficiently motivated to engage on the total study follow-up period, or likely to travel or to move before the end of the study,"}
• {"criterion_text":"- Patients with severe immunodeficiency disease requiring long term treatment or patients under chemotherapy or radiotherapy,"}
• {"criterion_text":"- Patients under listed homeopathic or phytotherapy treatment (see protocol),"}
• {"criterion_text":"- Patients addicted to or using recreational drugs,"}
• {"criterion_text":"- Patient under guardianship and/or curatorship,"}

Primary endpoints

• {"endpoint_text":"- Disappearance of warts at the end of treatment (6-month visit)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Disappearance of warts at 4 months.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Disappearance level (total disappearance, partial disappearance (50%), no modification, increase of number of warts) at 4 months and 6 months,","definition_or_measurement_approach":"Categorical levels of disappearance: total disappearance, partial disappearance (50%), no modification, increase in number of warts (assessed at 4 and 6 months)."}
• {"endpoint_text":"- Warts recurrence at 3-month visit post-treatment","definition_or_measurement_approach":"Assessment of recurrence at the visit 3 months after end of treatment."}
• {"endpoint_text":"- Pain evaluation during the study by VAS and consumption of antalgic medication.","definition_or_measurement_approach":"Pain measured by Visual Analogue Scale (VAS); concomitant analgesic consumption recorded."}
• {"endpoint_text":"- Safety: occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.","definition_or_measurement_approach":"Recording and classification of AEs and SAEs, with assessment of relationship to study drug."}

Belgium

Earliest CTIS Part Ii Submission Date

16-05-2024

Latest Decision Or Authorization Date

31-05-2024

Processing Time Days

15

Number Of Sites

11

Number Of Participants

162

Primary sponsor

Full Name

Labo'Life Belgium

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium