A double-blind, randomised, placebo-controlled, multicentre investigation, evaluating the performance,safety and usability of formic acid in subjects with warts on hand, foot, elbows and knees
- Conditions
- B07Viral warts
- Registration Number
- DRKS00006175
- Lead Sponsor
- MEDA Pharma GmbH & Co. KG (a Mylan company), Scientific Affairs, Clinical Affairs Meda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 240
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
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method