Glabellar LinesPhase 3BMI2006NCT05531968
Treatment of Moderate to Severe Glabellar Lines (BMI2006)
A Phase 3 study testing BMI2006 and BOTOX® in people with Glabellar Lines, run by BMI Korea at 3 sites in South Korea.
Trial summary
A multicenter, double-blind, randomized, parallel design, active control, phase 3 clinical trial to evaluate the efficacy and safety of 100 units of BMI 2006 and Botox® in adult patients in need of moderate or severe glabellar lines Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Glabellar Lines
- What is being tested?
- BMI2006 and BOTOX®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 9 Feb 2021to 17 Sep 2021
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged between 19 and 65
- Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
- Patients who fully understand the clinical trial and voluntarily sign the informed consent
Who cannot join
- Patients with neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis[ALS], etc.)
- Patients with facial palsy or blepharoptosis
- Patients who have marked facial asymmetry
- Patients whose glabellar lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands
- Patients who have received the medications that cause relaxation of muscles all over the body within 4 weeks prior to screening
- Muscle Relaxants (e.g., Tubocurarine chloride, Dantrolene sodium, Baclofen, etc.)
Show all 36Show fewer
- Spectinomycin hydrochloride
- Aminoglycoside antibiotics (e.g., Gentamicin sulfate, Neomycin sulfate, etc.)
- Polypeptide antibiotics (e.g., Polymyxin B sulfate, etc.)
- Tetracycline antibiotics
- Lincosamide antibiotics
- Aanticholinergic agent (e.g., Butylscopolamine bromide, Trihexyphenidyl hydrochloride, etc.)
- Benzodiazepines (e.g., Diazepam, Etizolam, etc.)
- Other medications that cause relaxation of muscles all over the body
- Patients who have received anticoagulant, antiplatelet agent or NSAIDs within 7 days before the first dose (Allow use of low-dose Aspirin[325 mg/day or less] for the antithrombotic therapy)
- Patients with skin disorders, infection or scars at the injection site
- Patients who have received other procedures which may affect glabellar and forehead lines within 12 months prior to screening
- Permanent soft tissue augmentation (e.g., Permanent filler, etc.)
- Face lifting (e.g., Forehead/Browlift, Thread lifting, etc.)
- Implant and Fat grafting
- Patients with the history of treatment of glabellar part(including forehead) which may affect the treatment results
- Hyaluronic Acid/Collagen fillers, Dermal resurfacing, Chemical Peeling, dermabrasion and Dermal Photorejuvenation within 6 months
- Dermer Filler and Nonpermanent soft tissue filler within 12 months
- Patients who have a plan to receive facial cosmetic procedures including dermal filler, photorejuvenation, chemical peeling and dermabrasion during the study period
- Patients who have a history of injecting drugs similar to the investigational drugs within 6 months prior to selection or are foreseen to use Botulinum Toxin A type or Botulinum Toxin B type during the study period
- Patients who have received Retinoids (e.g., isotretinoin, alitretinoin, etc.)
- Systemic agents: within 6 months prior to screening
- Topical agents: within 3 months prior to screening
- Patients with the history of alcohol or drug addiction
- Patients who have anxiety or mental disorder (e.g., depression) which may affect patient participation or objective efficacy assessment results based on the judgment of an investigator
- Fertile women and men who have a plan on being pregnant during the study or are not willing to use appropriate contraception
- Pregnant or lactating women
- Patients with allergy or hypersensitivity to the investigational drugs or their components
- Patients who have a disorder associated with malignant tumor, immunodeficiency(weak immune system), kidney disease, liver disease lung disease or etc., which is unsuitable for participation of the study based on the judgment of an investigator
- Patients who have participated in other clinical trials and were received or applied with other investigational products or investigational device within 30 days prior to screening
- Patients whom the investigator judges to be unsuitable to participate
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Chung-Ang University Hospital
Seoul, Heukseok-ro, Dongjak-gu, 06973
Konkuk University Hospital
Seoul, Neungdong-ro, Gwangjin-gu, 05030
Seoul Asan Medical Center
Seoul, Olympic-ro 43-gil, Songpa-gu, 05505
About this study
Official title: Multicenter, Double-blind, Randomized, Parallel Design, Active-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of 100 Units of BMI 2006 and Botox® in Adult Patients in Need of Moderate or Severe Glabellar Lines
A multicenter, double-blind, randomized, parallel design, active control, phase 3 clinical trial to evaluate the efficacy and safety of 100 units of BMI 2006 and Botox® in adult patients in need of moderate or severe glabellar lines
Read the detailed description
Purpose of clinical trial:
The purpose of this study was to evaluate the efficacy and safety of 20U dose administration of 100 units of BMI2006 in adult patients who needed moderate or severe glabellar lines.
primary purpose Comparing the effectiveness after administration of each 20U dose of 'BMI2006 100 Units' or 'Botox® Week' for adult patients in need of moderate or severe glabellar lines, it was found that the BMI2006 injection group was non-inferior to the Botox® injection group. wanted to confirm.
secondary purpose The purpose of this study was to evaluate the safety and effectiveness of 'BMI2006 100 Units' 20U compared to 'Botox® Injection' 20U for adult patients who need moderate or severe glabellar wrinkles.
This clinical trial was designed as a multicenter, double-blind, randomized, parallel design, active-controlled Phase 3 clinical trial, and was intended for patients with moderate or severe glabellar lines.
Only those subjects who have agreed in writing to voluntarily participate in the clinical trial and who are evaluated to meet the selection/exclusion criteria are 1:1 to the test group (BMI2006 week administration group) or control group (Botox®) in the order of participation in the clinical trial was randomly assigned.
Subjects assigned with randomization numbers were intramuscularly injected (IM) with a total of 20U of clinical trial drugs in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line. Thereafter, at 4, 8, 12, and 16 weeks at intervals of 4 weeks, the institution was visited to evaluate the efficacy and safety for a total of 16 weeks.
- Conditions
- Glabellar Lines
- Being tested
- BMI2006, BOTOX®
- Keywords
- BMI2006, BMI, Botulinum toxin, Clostridium botulinum Type A, BOTOX, BoNT-A, corrugator supercilii muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMI2006Biological
Also called Clostridium botulinum Type A
IM
BOTOX®Biological
Also called Clostridium botulinum Type A
IM
| Study group | Role | What they receive |
|---|---|---|
| BMI2006 100Units | Experimental | Patients were intramuscularly injected (IM) with a total of 20U of BMI2006 in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line. Receives: Biological: BMI2006 |
| Botox® | Active comparator | Patients were intramuscularly injected (IM) with a total of 20U of Botox® in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line. Receives: Biological: BOTOX® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change rate of glabellar line at maximum frown confirmed with investigator's on-site assessment of FWS
Change rate of glabellar line at maximum frown confirmed with investigator's on-site assessment of Facial Wrinkle Scale at baseline and 4 weeks after the injection
Measured: 0 and 4 weeks after the injection
Secondary outcomes (6)
Change rate of glabellar line at maximum frown confirmed with investigator's on-site assessment of FWS
Change rate of glabellar line at maximum frown confirmed with investigator's on-site assessment of Facial Wrinkle Scale at baseline, 8, 12 and 16 weeks after the injection
Measured: 0, 8, 12 and 16 weeks after the injection
Change rate of glabellar line at rest confirmed with investigator's on-site assessment of FWS
Change rate of glabellar line at rest confirmed with investigator's on-site assessment of Facial Wrinkle Scale at baseline, 4, 8, 12 and 16 weeks after the injection
Measured: 0, 4, 8, 12 and 16 weeks after the injection
Change rate of glabellar line at maximum frown confirmed with independent evaluator's photo assessment of FWS
Change rate of glabellar line at maximum frown confirmed with independent evaluator's photo assessment of Facial Wrinkle Scale at baseline, 4, 8,12, 16 weeks after the injection
Measured: 0, 4, 8,12 and 16 weeks after the injection
Change rate of glabellar line at rest confirmed with independent evaluator's photo assessment of FWS
Change rate of glabellar line at rest confirmed with independent evaluator's photo assessment of Facial Wrinkle Scale at baseline, 4, 8,12, 16 weeks after the injection
Measured: 0, 4, 8,12 and 16 weeks after the injection
Change rate of glabellar line confirmed with subject's assessment of the Subject Questionnaire
Change rate of glabellar line confirmed with subject's assessment of the Subject Questionnaire that underpin the nine-scale change of glabellar line at 4, 8, 12 and 16 weeks after the injection
Measured: 4, 8, 12 and 16 weeks after the injection
Satisfaction level using the Subject Satisfaction Questionnaire
Satisfaction level using the Subject Satisfaction Questionnaire that underpin the seven-scale measurement of satisfaction at 4, 8, 12 and 16 weeks after the injection
Measured: 4, 8, 12 and 16 weeks after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start9 Feb 2021
- Primary completion10 Aug 2021
- Study completion17 Sep 2021
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- BMI Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beom Joon Kim, MD, Ph.D., Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531968
- Sponsor's protocol ID
- BMI2006-SIT-02
- Acronym
- BMI2006
- Status last verified
- Sep 2022
- First submitted
- 31 Aug 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-blind, Randomized, Parallel Design, Active-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of 100 Units of BMI 2006 and Botox® in Adult Patients in Need of Moderate or Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT05531968
- Acronym / sponsor ID
- BMI2006 / BMI2006-SIT-02
- Conditions
- Glabellar Lines
- Keywords
- BMI2006, BMI, Botulinum toxin, Clostridium botulinum Type A, BOTOX, BoNT-A, corrugator supercilii muscle
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- BMI KoreaIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 8 Sep 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.
A multicenter, double-blind, randomized, parallel design, active control, phase 3 clinical trial to evaluate the efficacy and safety of 100 units of BMI 2006 and Botox® in adult patients in need of moderate or severe glabellar lines
Detailed description
Purpose of clinical trial:
The purpose of this study was to evaluate the efficacy and safety of 20U dose administration of 100 units of BMI2006 in adult patients who needed moderate or severe glabellar lines.
primary purpose Comparing the effectiveness after administration of each 20U dose of 'BMI2006 100 Units' or 'Botox® Week' for adult patients in need of moderate or severe glabellar lines, it was found that the BMI2006 injection group was non-inferior to the Botox® injection group. wanted to confirm.
secondary purpose The purpose of this study was to evaluate the safety and effectiveness of 'BMI2006 100 Units' 20U compared to 'Botox® Injection' 20U for adult patients who need moderate or severe glabellar wrinkles.
This clinical trial was designed as a multicenter, double-blind, randomized, parallel design, active-controlled Phase 3 clinical trial, and was intended for patients with moderate or severe glabellar lines.
Only those subjects who have agreed in writing to voluntarily participate in the clinical trial and who are evaluated to meet the selection/exclusion criteria are 1:1 to the test group (BMI2006 week administration group) or control group (Botox®) in the order of participation in the clinical trial was randomly assigned.
Subjects assigned with randomization numbers were intramuscularly injected (IM) with a total of 20U of clinical trial drugs in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line. Thereafter, at 4, 8, 12, and 16 weeks at intervals of 4 weeks, the institution was visited to evaluate the efficacy and safety for a total of 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI2006 100Units | Experimental | Biological: BMI2006Patients were intramuscularly injected (IM) with a total of 20U of BMI2006 in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line. |
| Botox® | Active comparator | Biological: BOTOX®Patients were intramuscularly injected (IM) with a total of 20U of Botox® in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged between 19 and 65
- Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
- Patients who fully understand the clinical trial and voluntarily sign the informed consent
Key exclusion criteria (36 listed)
- Patients with neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis[ALS], etc.)
- Patients with facial palsy or blepharoptosis
- Patients who have marked facial asymmetry
- Patients whose glabellar lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands
- Patients who have received the medications that cause relaxation of muscles all over the body within 4 weeks prior to screening
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 |
|---|---|---|
| BMI2006Also: Clostridium botulinum Type AIM | Biological | BMI2006 100Units |
| BOTOX®Also: Clostridium botulinum Type AIM | Biological | Botox® |
Primary outcome
Change rate of glabellar line at maximum frown confirmed with investigator's on-site assessment of FWS
Time frame: 0 and 4 weeks after the injection
Change rate of glabellar line at maximum frown confirmed with investigator's on-site assessment of Facial Wrinkle Scale at baseline and 4 weeks after the injection
6 secondary outcomes
Change rate of glabellar line at maximum frown confirmed with investigator's on-site assessment of FWS
Time frame: 0, 8, 12 and 16 weeks after the injection
Change rate of glabellar line at rest confirmed with investigator's on-site assessment of FWS
Time frame: 0, 4, 8, 12 and 16 weeks after the injection
Change rate of glabellar line at maximum frown confirmed with independent evaluator's photo assessment of FWS
Time frame: 0, 4, 8,12 and 16 weeks after the injection
Change rate of glabellar line at rest confirmed with independent evaluator's photo assessment of FWS
Time frame: 0, 4, 8,12 and 16 weeks after the injection
Change rate of glabellar line confirmed with subject's assessment of the Subject Questionnaire
Time frame: 4, 8, 12 and 16 weeks after the injection
Satisfaction level using the Subject Satisfaction Questionnaire
Time frame: 4, 8, 12 and 16 weeks after the 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 8 Sep 2022.
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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.
Beom Joon Kim, MD, Ph.D. principal investigator
Chung-Ang University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BMI2006 and BOTOX® in people with Glabellar Lines, run by BMI Korea at 3 sites 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 3 inclusion and 36 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 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Change rate of glabellar line at maximum frown confirmed with investigator's on-site assessment of FWS (time frame: 0 and 4 weeks after the injection). 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 8 Sep 2022.