Glabellar LinesPhase 3NCT05380154
Efficacy and Safety Assessment of Botulax® and BOTOX® for Improvement of Glabellar Lines.
A Phase 3 study testing Botulinum Toxin A type for injection (Botulax®) and Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®) in people with Glabellar Lines, run by Hugel at 1 site in South Korea.
Trial summary
This study is a phase 3 clinical trial of multi-center, random, blinded*, parallel control, and positive control to evaluate the efficacy and safety of Botulax® Injection compared to BOTOX® for improving moderate to severe glabellar wrinkles. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glabellar Lines
- What is being tested?
- Botulinum Toxin A type for injection (Botulax®) and Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 May 2017to 6 Jul 2018
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 - 65 years (inclusive), no gender preference
- The evaluator at each institution assesses the severity level of glabellar wrinkles at the site in the field when the test subject frowns as much as possible according to the 4-point photographic evaluation table and classifies the subjects with a rating of ≥ 2 (medium or severe).
- Persons who can follow the test well, fully understand the clinical trial, rationally foresee the cost-effectiveness of injection, and adhere to the study procedure until the end of the clinical trial are selected.
- The test subjects fully understand the test requirements and voluntarily sign the consent form.
Who cannot join
- Subjects who have a history of oversensitivity to the Botulinum Toxin A type, Botulinum Toxin B type, or other control groups of the tested drug substance.
- Subjects with clear scars, infections, a carcinogenic or cancerous metastatic lesion on the upper part of the face and/or unrecovered wounds on the face.
- Subjects with skin disease, such as dermatitis and acne, or scar on the face, which the investigator judges can affect the evaluation of treatment effectiveness or safety of the test subject.
- Subjects who took anticoagulant drugs (e.g., aspirin, nonsteroidal anti-inflammatory drugs, clopidogrel, warfarin, etc.) within two weeks prior to selection; the test subjects who are menstruating can avoid it by delaying the injection of studied products as needed.
- Subjects who took drugs with muscle relaxation effects (e.g., muscle relaxants, Curare-like substances, anticholinergic drugs, spectinomycin hydrochloride, aminoglycoside-based drugs, polypeptide antibiotics, tetracycline, lincomycin-based drugs, anticholinergics, benzodiazepines and similar drugs, or benzamide drugs) within 4 weeks prior to selection, anticholinergics, benzodiazepines and similar drugs, or benzamide drugs) or are foreseen to use the above drugs during the study period (for 16 weeks after the injection treatment).
- Subjects who have used external medications (e.g., glucocorticoids or tretinoin ointment) on the upper part of the face within 4 weeks prior to the selection or are foreseen to use the drug on the upper part of the face during the study period (for 16 weeks after the injection treatment).
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- Subjects who have a history of injecting drugs similar to the study drug within 6 months prior to selection or are foreseen to use during the study period (Botulinum Toxin A type or Botulinum Toxin B type).
- Subjects who have undergone eye shape correction, laser skin transplantation, skin surgery, IPL, frequency surgery, dermabrasion, chemical dermabrasion, or other laser resolution and nonresolution surgery within 6 months prior to selection or are foreseen to do so during the study period.
- Subjects who have had injected hyaluronic acid in the upper part of their face within 12 months prior to selection or plan to do it.
- Subjects who have a history of surgery to remove wrinkles on the face above the eyes or a permanent filling injection.
- Subjects who plan to undergo a wrinkle removal surgery on their face during the study period, an injection filling of soft tissue for wrinkle removal, or other facial plastic surgeries.
- Subjects whom the investigator judges to be unsuitable to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Clinical Study of Efficacy and Safety Assessment; Multi-center, Randomized, Blind, and Parallel Control; and Positive Control of Botulax® Injection and BOTOX® for Improvement of Moderate to Severe Glabellar Wrinkles
This study is a phase 3 clinical trial of multi-center, random, blinded*, parallel control, and positive control to evaluate the efficacy and safety of Botulax® Injection compared to BOTOX® for improving moderate to severe glabellar wrinkles.
Read the detailed description
The case test of 500 qualified test subjects was conducted in 13 institutions nationwide in China. Those who meet all selection criteria and do not meet any of the exclusion criteria are selected as suitable test subjects. The selected test subjects are blinded and divided into the Botulax test group or the BOTOX test group.
- Conditions
- Glabellar Lines
- Being tested
- Botulinum Toxin A type for injection (Botulax®), Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®)
- Keywords
- botulinum toxin type A, Glabellar lines, wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin A type for injection (Botulax®)Drug
Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects
Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®)Drug
Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Botulinum Toxin A type for injection (Botulax®) Receives: Drug: Botulinum Toxin A type for injection (Botulax®) |
| control group | Active comparator | Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®) Receives: Drug: Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate of improvement in glabellar lines with Physician's rating of line severity
The rate of test subjects receiving 0 or 1 point by the institution evaluator who assesses the glabellar wrinkles (at maximum frown) at the site in week 4.
Measured: Week 4
Secondary outcomes (6)
Responder rate of improvement in glabellar lines with Physician's rating of line severity
The rate of test subjects receiving 0 or 1 point by the institution evaluator who assesses the glabellar wrinkles (at maximum frown)at the site in weeks 1, 8, 12, and 16 after the treatment
Measured: weeks 1, 8, 12, and 16 after the treatment
Responder rate of improvement in glabellar lines at rest with Physician's assessment of severity
The rate of test subjects receiving 0 or 1 point by the institution evaluator who assesses the glabellar wrinkles (when at rest) at the site in weeks 1, 4, 8, 12, and 16 after the treatment
Measured: weeks 1, 4, 8, 12, and 16 after the treatment
Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment
The rate of test subjects receiving 0 or 1 point by the Independent Evaluation Committee based on the photo of the glabellar wrinkles (at maximum frown) in weeks 1, 4, 8, 12, and 16 after the treatment
Measured: weeks 1, 4, 8, 12, and 16 after the treatment
Responder rate of improvement in glabellar lines at rest with investigator's photo assessment
The rate of test subjects receiving 0 or 1 point by the Independent Evaluation Committee based on the photo of the glabellar wrinkles (when at rest) in weeks 1, 4, 8, 12, and 16 after the treatment
Measured: weeks 1, 4, 8, 12, and 16 after the treatment
Responder rate of improvement in glabellar lines with Subject's improvement assessment
The rate of test subjects who self-assess that the treatment is effective (by giving a score of "+2" or higher) in weeks 1, 4, 8, 12, and 16 after the treatment
Measured: weeks 1, 4, 8, 12, and 16 after the treatment
Subject's satisfaction rate
The rate of test subjects who are satisfied with the treatment effect (test subject's satisfaction rating of 6 - 7) in weeks 1, 4, 8, 12, and 16 after the treatment
Measured: weeks 1, 4, 8, 12, and 16 after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start9 May 2017
- Primary completion22 Jan 2018
- Study completion6 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar LinesStudies of the same condition, open and under way.
- 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugel
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sihuan Pharmaceutical Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380154
- Sponsor's protocol ID
- Botulax-3001
- Status last verified
- Apr 2022
- First submitted
- 12 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Clinical Study of Efficacy and Safety Assessment; Multi-center, Randomized, Blind, and Parallel Control; and Positive Control of Botulax® Injection and BOTOX® for Improvement of Moderate to Severe Glabellar Wrinkles
- ClinicalTrials.gov ID
- NCT05380154
- Acronym / sponsor ID
- Botulax-3001
- Conditions
- Glabellar Lines
- Keywords
- botulinum toxin type A, Glabellar lines, wrinkles
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- HugelIndustry (pharma, biotech, devices)
- Collaborators
- Sihuan Pharmaceutical Limited
- Study start
- 9 May 2017 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 18 May 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.
This study is a phase 3 clinical trial of multi-center, random, blinded*, parallel control, and positive control to evaluate the efficacy and safety of Botulax® Injection compared to BOTOX® for improving moderate to severe glabellar wrinkles.
Detailed description
The case test of 500 qualified test subjects was conducted in 13 institutions nationwide in China. Those who meet all selection criteria and do not meet any of the exclusion criteria are selected as suitable test subjects. The selected test subjects are blinded and divided into the Botulax test group or the BOTOX test group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Botulinum Toxin A type for injection (Botulax®)Botulinum Toxin A type for injection (Botulax®) |
| control group | Active comparator | Drug: Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®)Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 - 65 years (inclusive), no gender preference
- The evaluator at each institution assesses the severity level of glabellar wrinkles at the site in the field when the test subject frowns as much as possible according to the 4-point photographic evaluation table and classifies the subjects with a rating of ≥ 2 (medium or severe).
- Persons who can follow the test well, fully understand the clinical trial, rationally foresee the cost-effectiveness of injection, and adhere to the study procedure until the end of the clinical trial are selected.
- The test subjects fully understand the test requirements and voluntarily sign the consent form.
Key exclusion criteria (12 listed)
- Subjects who have a history of oversensitivity to the Botulinum Toxin A type, Botulinum Toxin B type, or other control groups of the tested drug substance.
- Subjects with clear scars, infections, a carcinogenic or cancerous metastatic lesion on the upper part of the face and/or unrecovered wounds on the face.
- Subjects with skin disease, such as dermatitis and acne, or scar on the face, which the investigator judges can affect the evaluation of treatment effectiveness or safety of the test subject.
- Subjects who took anticoagulant drugs (e.g., aspirin, nonsteroidal anti-inflammatory drugs, clopidogrel, warfarin, etc.) within two weeks prior to selection; the test subjects who are menstruating can avoid it by delaying the injection of studied products as needed.
- Subjects who took drugs with muscle relaxation effects (e.g., muscle relaxants, Curare-like substances, anticholinergic drugs, spectinomycin hydrochloride, aminoglycoside-based drugs, polypeptide antibiotics, tetracycline, lincomycin-based drugs, anticholinergics, benzodiazepines and similar drugs, or benzamide drugs) within 4 weeks prior to selection, anticholinergics, benzodiazepines and similar drugs, or benzamide drugs) or are foreseen to use the above drugs during the study period (for 16 weeks after the injection treatment).
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 A type for injection (Botulax®)Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects | Drug | Test group |
| Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®)Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects. | Drug | control group |
Primary outcome
Responder rate of improvement in glabellar lines with Physician's rating of line severity
Time frame: Week 4
The rate of test subjects receiving 0 or 1 point by the institution evaluator who assesses the glabellar wrinkles (at maximum frown) at the site in week 4.
6 secondary outcomes
Responder rate of improvement in glabellar lines with Physician's rating of line severity
Time frame: weeks 1, 8, 12, and 16 after the treatment
Responder rate of improvement in glabellar lines at rest with Physician's assessment of severity
Time frame: weeks 1, 4, 8, 12, and 16 after the treatment
Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment
Time frame: weeks 1, 4, 8, 12, and 16 after the treatment
Responder rate of improvement in glabellar lines at rest with investigator's photo assessment
Time frame: weeks 1, 4, 8, 12, and 16 after the treatment
Responder rate of improvement in glabellar lines with Subject's improvement assessment
Time frame: weeks 1, 4, 8, 12, and 16 after the treatment
Subject's satisfaction rate
Time frame: weeks 1, 4, 8, 12, and 16 after the treatment
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 24 May 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin A type for injection (Botulax®) and Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®) in people with Glabellar Lines, run by Hugel at 1 site in South Korea.
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 12 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 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Responder rate of improvement in glabellar lines with Physician's rating of line severity (time frame: Week 4). 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 24 May 2022.