B07
Conditions
Interventions
Group 1: Treatment of 1-5 target warts until clearance of all warts or for a maximum of 15 weeks. Once weekly administration of formic acid solution (85%) with 2-3 times pressing the tip of the pen on
Sponsors
MEDA Pharma GmbH & Co. KG (a Mylan company), Scientific Affairs, Clinical Affairs Meda
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects having 1-5 warts on hand, feet, ellbows or knees which have been visible for no longer than 12 months (target warts) 2. Subjects with age =2 years at time of randomisation 3. Written informed consent of adult subjects (age =18 years) or legal representative (for children <18 years) 4. Written informed assent of children (=14 years) 5. Verbal assent of children <14 years having sufficient understanding and intelligence to understand what is proposed to give verbal consent 6. Willingness to comply with the obligations of the investigation
Exclusion criteria
Exclusion criteria: Safety concerns: 1. History of allergic reaction to the IP or their excipients: lemon oil, glycerine, parabenes. Lack of suitability for the investigation: 2. Skin defects (bruises, soreness, active inflammatory lesions, tumours, mollusks = molluscum contagiosum) or sensorial disorders (caused e.g. by diabetes) close to the target wart(s). 3. History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological disease within the last 2 years, or other condition that in the investigator’s opinion may interfere with a subject’s ability to comply with the CIP. 4. Subjects with diabetes mellitus not adequately controlled in the opinion of the treating physician or the investigator. 5. Previous local (including mechanical) treatment of target wart(s) containing alone or in combination formic acid, trichloroacetic acid (TCA), prescribed topical treatments with nitric acid and/ or 5-fluorouracil (5-FU) as well as cryotherapy (freezing), and surgical interventions (curettage, cautery, laser). 6. Exposure to another IP within the last month. Administrative reasons: 7. Difficulty to understand given written and verbal instructions for use (adults or legal representative(s), and children =14 years). 8. Lack of willingness to have personal investigation related data collected, archived or transmitted according to protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with complete clearance of all target warts at final visit (final visit after clearance of the last target wart or after 15 weeks of treatment at the latest). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of subjects aged =2 to =5 years with complete clearance of all target warts at final visit - Proportion of subjects with complete clearance of all target plantar warts at final visit - Proportion of subjects with complete clearance of all target hand/body warts at final visit - Number and clearance of target warts per subject and overall - Number and clearance of target warts for children aged =2 to =5 years per subject and overall - Number and clearance of target plantar warts per subject and overall - Number and clearance of target hand-/body warts per subject and overall - Time to complete clearance of all target warts (in terms of days until date of final visit) - Time to clearance of any target wart - Local and systemic safety and tolerability assessed by investigator - Phone questionnaires by site personnel for correct application, number of warts, adverse events (AEs) - Investigator’s assessment of performance of investigational product (IP) - Subject’s assessment of performance of IP - Subject’s assessment of usability of IP - Subject’s assessment of gentleness of IP - Investigator’s overall assessment of safety and tolerability of IP at final visit | — |
Countries
Sweden
Contacts
Public ContactRainer Porrmann
Meda Pharma GmbH & Co. KG (a Mylan company), Clinical Science & Operations
Outcome results
None listed