Healthy human volunteers Botulinum Toxins, Injections, Intramuscular
Conditions
Interventions
Incobotulinum toxin will be injected into the upper face (40 units) and both masseters (60 units) for a total of 100 units. The injection location will be the same for every subject. HBM Norge AS will
Sponsors
Dermatologic Surgery, Dermatology department, Siriraj hospital, Thailand
Merz Aesthetics Thailand,Galderma Thailand,Daewong Thailand,Hugel,inc
Eligibility
Sex/Gender
All
Age
25 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female volunteers age 25-45 years, 2. No history of botulinum toxin treatment failure, 3. No history of immunodeficiency disease or taking any immunosuppressive drug, 4. Have masseter muscle prominent
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 4. Using an energy-based device or other interventions 6 months prior
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bite force Before intervention, 14 days, 1, 2, 3, 4, 5 and 6 months after the intervention Bite force will be measured by HBM Norge AS in neuton,wrinkle improvement scale Before intervention, 14 days, 1, 2, 3, 4, 5 and 6 months after the intervention Antera3d will be used to measure periorbital wrinkles,Physicians assessment score 14 days, 1, 2, 3, 4, 5 and 6 months after the intervention percentage of Physicians assessment score,Subject self assessment score 14 days, 1, 2, 3, 4, 5 and 6 months after the intervention percentage of Subject self assessment score | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain score immediate after the intervention Visual analogue scale (0-10) | — |
Countries
Thailand
Contacts
Public ContactSurachet Sirisuthivoranunt
Research department
Outcome results
None listed