To study safety and tolerability of new medical device in human beings microneedle patch
Conditions
Interventions
20 subjects will be applied patch for 24 hours,20 subjects will be applied patch for 48 hours,20 subjects will be applied patch for 72 hours
Other,Other,Other
microneedle patch application for 24 hours,microneedle patch application for 48 hours,microneedle patch application for 72 hours
Sponsors
Armed Forces Research Institute of Medical Sciences (AFRIMS)
์N/A
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) Thai nationality 2) Age 20-50 years 3) if female, not be pregnant 4) no severe underlying disease
Exclusion criteria
Exclusion criteria: 1) have history of psychiatric disease 2) have history of allergy to any drug or vaccine 3) during breast feeding 4) during treatment with any immunosuppressive drug or clinical trial study with vaccine or drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, Tolerability 24-72 hours after microneedle patch application Adverse Event | — |
Secondary
| Measure | Time frame |
|---|---|
| Local skin reaction 24-72 hours after microneedle patch application Primary irritation in humans by National Academy of Sciences (NAS) scores | — |
Countries
Thailand
Contacts
Public ContactKhunakorn Kana
AFRIMS
Outcome results
None listed