FindTrial
Sign In

The study to compare the immune response between intradermal and intramuscular injection of botulinum toxin A

The study to compare the immune response between intradermal and intramuscular injection of botulinum toxin A; Prospective study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20211204002
Enrollment
100
Registered
2021-12-04
Start date
2021-10-04
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy human volunteers Enzyme-Linked Immunosorbent Assay, Botulinum Toxins, Immunoglobulins, Antibodies

Interventions

Intradermal injection of botulinum toxin for 100 units into the subjects&#039
face and neck for lifting 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 blood wi
masseter and upper face. 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 exami
Active Comparator Drug,Active Comparator Drug
Intradermal injection of botulinum toxin,Intramuscular injection of botulinum toxin

Sponsors

Dermatologic Surgery, Dermatology department, Siriraj hospital, Thailand
Lead Sponsor
Merz Aesthetics Thailand,Galderma Thailand,Daewong Thailand,Hugel,inc
Collaborator

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,

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

MeasureTime frame
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

MeasureTime frame
Neutralizing 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—

Countries

Thailand

Contacts

Public ContactSurachet Sirisuthivoranunt

Research department

siri.surachet@gmail.com024199933

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026