Differences in antibody responses of intradermal and intramuscular injections of botulinum toxin type A
Phase 4
Completed
- Conditions
- Healthy human volunteersEnzyme-Linked Immunosorbent Assay, Botulinum Toxins, Immunoglobulins, Antibodies
- Registration Number
- TCTR20211215001
- Lead Sponsor
- Dermatologic Surgery, Dermatology department, Siriraj hospital, Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 119
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
1. pregnant or lactating woman, 2. Was treated with botulinum toxin during 6 months prior, 3. Having the skin disease around the treated area
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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