Status:
COMPLETED
A Study of Botulinum Toxin Type A Treatment of Wrinkles in Asian
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Botulinum Toxin, Type A
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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-...
Detailed Description
This was a self-reported, randomized, parallel-group, double-blinded controlled multicenter clinical trial. It was conducted in Wuhan, Shanghai, and Dongguan, China, at the plastic and reconstructive ...
Eligibility Criteria
Inclusion
- 1\. Chinese males or females aged over 18 years old who want to accept medical removal of the wrinkle;
- 2\. Noticeable symmetrical wrinkles on both sides of the face (grade 1-4 on the 5-grade Wrinkles Severity Rating Scale);
- 3\. Female patients must take a pregnancy test to prove they are not pregnant, and they are also asked to use a method of contraception 30 days before inclusion into the group and to use a reliable method of contraception throughout the entire study;
- 4\. Patients should not accept other forms of cosmetic intervention and agree to refrain from participation in any other clinical trials that may interrupt the study.
Exclusion
- 1\. The wrinkle severity of any site or both sites are either grade 0 or 5 on the 5-grade Wrinkle Severity Rating Scale.
- 2\. The presence of facial hair that may influence the observation of wrinkle severity;
- 3\. The area of injection had an apparent acne scar, active inflammation, infection, cancer or premalignancy, or untreated wound;
- 4\. Patients who had facial plastic surgery, tissue transplant, silica gel, liposome (fat) injection, or other permanent or semipermanent dermal filler;
- 5\. Patients who had any type of Botox injection in the last year or were injected more than 3 times.
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2017
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05324839
Start Date
February 1 2014
End Date
March 2 2017
Last Update
April 12 2022
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