Botulinum Toxin, Type AEarly Phase 1NCT05324839
A Study of Botulinum Toxin Type A Treatment of Wrinkles in Asian
A Early Phase 1 study testing Botulinum toxin type A in people with Botulinum Toxin, Type A, run by Shanghai Jiao Tong University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Botulinum Toxin, Type A
- What is being tested?
- Botulinum toxin type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2014to 2 Mar 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Botulinum Toxin, Type A
- Being tested
- Botulinum toxin type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injecting different dosage to different group
| Study group | Role | What they receive |
|---|---|---|
| score 1 before injection | Experimental | We injected 1-5 u of BoNTA into score 1 crow's feet lines before being included Receives: Drug: Botulinum toxin type A |
| score 2 before injection | Experimental | 2-6 u of BoNTA into score 2 crow's feet lines Receives: Drug: Botulinum toxin type A |
| score 3 before injection | Experimental | 3-10 u of BoNTA into score 3 crow's feet lines Receives: Drug: Botulinum toxin type A |
| score 4 before injection | Experimental | 5-15 u of BoNTA into score 4 crow's feet lines. Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: One year after injecting BoNTA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Feb 2014
- Primary completion1 Mar 2014
- Study completion2 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Botulinum Toxin, Type AStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yun Xie, M.D., Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324839
- Sponsor's protocol ID
- SH9H-2022-T221-2
- Status last verified
- Apr 2022
- First submitted
- 9 Mar 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the status of the participents
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Double-Blinded, Randomized, Parallel-Group, Dose-Ranging Study of Botulinum Toxin Type A Treatment of Wrinkles in Asian
- ClinicalTrials.gov ID
- NCT05324839
- Acronym / sponsor ID
- SH9H-2022-T221-2
- Conditions
- Botulinum Toxin, Type A
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 1 Mar 2014 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| score 1 before injection | Experimental | Drug: Botulinum toxin type AWe injected 1-5 u of BoNTA into score 1 crow's feet lines before being included |
| score 2 before injection | Experimental | Drug: Botulinum toxin type A2-6 u of BoNTA into score 2 crow's feet lines |
| score 3 before injection | Experimental | Drug: Botulinum toxin type A3-10 u of BoNTA into score 3 crow's feet lines |
| score 4 before injection | Experimental | Drug: Botulinum toxin type A5-15 u of BoNTA into score 4 crow's feet lines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type Ainjecting different dosage to different group | Drug | score 1 before injection, score 2 before injection, score 3 before injection, score 4 before injection |
Primary outcome
The change of wrinkle serenity rating scale after 2 weeks
Time frame: Two weeks after injecting BoNTA
Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale 2 weeks after Botox injection
The change of wrinkle serenity rating scale after one month
Time frame: One month after injecting BoNTA
Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale one month after Botox injection
The change of wrinkle serenity rating scale after three months
Time frame: Three months after injecting BoNTA
Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale three months after Botox injection
The change of wrinkle serenity rating scale after six months
Time frame: Six months after injecting BoNTA
Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale six months after Botox injection
The change of wrinkle serenity rating scale after nine months
Time frame: Nine months after injecting BoNTA
Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale nine months after Botox injection
The change of wrinkle serenity rating scale after one year
Time frame: One year after injecting BoNTA
Compare wrinkle severity according to the 5-grade Wrinkle Severity Rating Scale one year after Botox injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: Yes. the status of the participents
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun Xie, M.D. principal investigator
Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Botulinum toxin type A in people with Botulinum Toxin, Type A, run by Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of wrinkle serenity rating scale after 2 weeks (time frame: Two weeks after injecting BoNTA). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.