The study to compare the immune response between intradermal and intramuscular injection of botulinum toxin A
Phase 4
Completed
- Conditions
- Healthy human volunteersEnzyme-Linked Immunosorbent Assay, Botulinum Toxins, Immunoglobulins, Antibodies
- Registration Number
- TCTR20211204002
- 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
- 100
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,
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 the intervention is started Level of botulinum toxin antibody by ELISA test,Botulinum toxin antibody 14 days after the intervention Level of botulinum toxin antibody by ELISA test,Botulinum toxin antibody 1 month after the intervention Level of botulinum toxin antibody by ELISA test,Botulinum toxin antibody 3 month after the intervention Level of botulinum toxin antibody by ELISA test,Botulinum toxin antibody 6 month after the intervention Level of botulinum toxin antibody by ELISA test
- Secondary Outcome Measures
Name Time Method eutralizing antibody against botulinum toxin before the intervention is started Percentage of neutralizing antibody by ELISA test,Neutralizing antibody against botulinum toxin 14 days after the intervention Percentage of neutralizing antibody by ELISA test,Neutralizing antibody against botulinum toxin 1 month after the intervention Percentage of neutralizing antibody by ELISA test,Neutralizing antibody against botulinum toxin 3 month after the intervention Percentage of neutralizing antibody by ELISA test,Neutralizing antibody against botulinum toxin 6 month after the intervention Percentage of neutralizing antibody by ELISA test