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

A Multicenter, Prospective, Double-Blinded, Randomized, Parallel-Group, Dose-Ranging Study of Botulinum Toxin Type A Treatment of Wrinkles in Asian

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.

Study Overview

• Status: Completed
• Conditions: Botulinum Toxin, Type A
• Intervention / Treatment: Drug: Botulinum toxin type A

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 surgery, and approved by the ethics committee of Shanghai Ninth People's Hospital, affiliated to Shanghai Jiao Tong University School of Medicine. All patients were fully informed about the study in accordance with the applicable regulations and International Conference on Harmonisation Good Clinical Practices guidelines and gave written informed consent before the study. The main inclusion criteria were: 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. The main exclusion criteria were: 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 semi-permanent dermal filler; 5. patients who had any type of Botox injection in the last year or were injected more than 3 times.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: score 1 before injection; We injected 1-5 u of BoNTA into score 1 crow's feet lines before being included	Drug: Botulinum toxin type A; injecting different dosage to different group
Experimental: score 2 before injection; 2-6 u of BoNTA into score 2 crow's feet lines	Drug: Botulinum toxin type A; injecting different dosage to different group
Experimental: score 3 before injection; 3-10 u of BoNTA into score 3 crow's feet lines	Drug: Botulinum toxin type A; injecting different dosage to different group
Experimental: score 4 before injection; 5-15 u of BoNTA into score 4 crow's feet lines.	Drug: Botulinum toxin type A; injecting different dosage to different group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of wrinkle serenity rating scale after 2 weeks	Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale 2 weeks after Botox injection	Two weeks after injecting BoNTA
The change of wrinkle serenity rating scale after one month	Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale one month after Botox injection	One month after injecting BoNTA
The change of wrinkle serenity rating scale after three months	Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale three months after Botox injection	Three months after injecting BoNTA
The change of wrinkle serenity rating scale after six months	Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale six months after Botox injection	Six months after injecting BoNTA
The change of wrinkle serenity rating scale after nine months	Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale nine months after Botox injection	Nine months after injecting BoNTA
The change of wrinkle serenity rating scale after one year	Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale one year after Botox injection	One year after injecting BoNTA

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Yun Xie, M.D., Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 2, 2017

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: April 9, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: SH9H-2022-T221-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: the status of the participents
• IPD Sharing Supporting Information Type: Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No