drugset / Trial / NCT05324839

A Study of Botulinum Toxin Type A Treatment of Wrinkles in Asian

NCT05324839

Phase 0 Completed 250 enrolled Shanghai Jiao Tong University School of Medicine
RandomizedParallel-groupDouble-blindTreatment

Summary

OBJECTIVES: The aim of this randomized, parallel-group, double-blinded controlled multicenter clinical trial is to determine the proper dosage of botulinum toxin type A in Asian, and provide evidence-based proof. METHODS: 250 patients were included in this study, first, trained observers assessed their wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale before injecting botulinum toxin type A, then we injected different dosages to patients with the different pre-injection scores. All patients were followed up for up to one year. Logistic regression was built, the chi-square test was performed, and R square and p-value are used for evaluation.

Timeline

Start
2014-02-01
Primary completion
2014-03-01
Completion
2017-03-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 1 iu
Subject Botulinum toxin type A Protein / enzyme biologic 2 iu
Subject Botulinum toxin type A Protein / enzyme biologic 3 iu
Subject Botulinum toxin type A Protein / enzyme biologic 5 iu
Subject Botulinum toxin type A Protein / enzyme biologic 6 iu
Subject Botulinum toxin type A Protein / enzyme biologic 10 iu
Subject Botulinum toxin type A Protein / enzyme biologic 15 iu