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

NCT05324839 | Completed Early Phase 1

• 1 other identifier: SH9H-2022-T221-2
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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-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.

Conditions

Botulinum Toxin, Type A

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (4)

score 1 before injection

EXPERIMENTAL

We injected 1-5 u of BoNTA into score 1 crow's feet lines before being included

Drug: Botulinum toxin type A

score 2 before injection

EXPERIMENTAL

2-6 u of BoNTA into score 2 crow's feet lines

Drug: Botulinum toxin type A

score 3 before injection

EXPERIMENTAL

3-10 u of BoNTA into score 3 crow's feet lines

Drug: Botulinum toxin type A

score 4 before injection

EXPERIMENTAL

5-15 u of BoNTA into score 4 crow's feet lines.

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type A DRUG

injecting different dosage to different group

score 1 before injection; score 2 before injection; score 3 before injection; score 4 before injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Chinese males or females aged over 18 years old who want to accept medical removal of the wrinkle;
• \. Noticeable symmetrical wrinkles on both sides of the face (grade 1-4 on the 5-grade Wrinkles Severity Rating Scale);
• \. 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.

You may not qualify if:

• \. The wrinkle severity of any site or both sites are either grade 0 or 5 on the 5-grade Wrinkle Severity Rating Scale.
• \. The presence of facial hair that may influence the observation of wrinkle severity;
• \. The area of injection had an apparent acne scar, active inflammation, infection, cancer or premalignancy, or untreated wound;
• \. Patients who had facial plastic surgery, tissue transplant, silica gel, liposome (fat) injection, or other permanent or semipermanent dermal filler;
• \. Patients who had any type of Botox injection in the last year or were injected more than 3 times.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Yun Xie, M.D.

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: April 12, 2022
• Study Start: February 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 2, 2017
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR