Healthy human volunteers Enzyme-Linked Immunosorbent Assay, Botulinum Toxins, Immunoglobulins, Antibodies
Conditions
Interventions
Intradermal injection of botulinum toxin for 50 units into the subjects'
upper face for wrinkle reduction purposes. The blood will be drawn from the subject before botulinum toxin injection and 2 weeks, 1 month, 3 months, and 6 months after botulinum toxin injection. The b
masseter. The blood will be drawn from the subject before botulinum toxin injection and 2 weeks, 1 month, 3 months, and 6 months after botulinum toxin injection. The blood will be examined the level o
Active Comparator Drug,Active Comparator Drug
Sponsors
Dermatologic Surgery, Dermatology department, Siriraj hospital, Thailand
Merz Aesthetics Thailand,Galderma Thailand,Daewong Thailand,Hugel,inc,Aestec pharma
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female volunteers age 18-60 years, 2. No history of botulinum toxin treatment failure, 3. No history of immunodeficiency disease or taking any immunosuppressive drug,
Exclusion criteria
Exclusion criteria: 1. pregnant or lactating woman, 2. Was treated with botulinum toxin during 6 months prior, 3. Having the skin disease around the treated area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Botulinum toxin antibody Before and 14 days, 1 month, 3 months, 6 months after the intervention Level of botulinum toxin antibody by ELISA test,Neutralizing antibody against botulinum toxin Before and 14 days, 1 month, 3 months, 6 months after the intervention Percentage of neutralizing antibody by ELISA test | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody against complexing protein of botulinum toxin Before and 14 days, 1 month, 3 months, 6 months after the intervention Percentage of antibody against complexing protein of botulinum toxin by ELISA test | — |
Countries
Thailand
Contacts
Public ContactSurachet Sirisuthivoranunt
Dermatology department
Outcome results
None listed