Glabellar LinesPhase 3NCT07622004
Evaluate the Efficacy and Safety of INI101 Compared to BOTOX® in Subjects With Moderate to Severe Glabellar Lines.
A Phase 3 study testing Botulinum Toxin Type A Injection [INI101] and Botulinum Toxin Type A Injection [Botox] in people with Glabellar Lines, run by INIBIO Co., Ltd. at 1 site in South Korea.
Trial summary
To evaluate the efficacy and safety of botulinum toxin type A for injection INI101 compared to BOTOX® in subjects with moderate to severe glabellar lines. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glabellar Lines
- What is being tested?
- Botulinum Toxin Type A Injection [INI101] and Botulinum Toxin Type A Injection [Botox]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 May 2021to 5 Mar 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female participants aged between 19 and 65 years old.
- Participants whose glabellar line score was 2 (moderate) or higher of glabellar line score at maximum frown based on the investigator's judgment at screening and randomization.
- Participants who voluntarily gave a consent in writing to participate in the clinical study with full knowledge of details of the study after listening to them.
- Participants who can understand and comply with the procedures and visit schedules of the study.
Who cannot join
- Systemic neuromuscular junction disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, hereditary motor neuropathy, etc.)
- History of blepharoplegia or ptosis
- Prominent facial asymmetry
- Glabellar lines that are physically difficult to be improved, such as the case where the lines are not removed by hands
- Participants who have received any drugs that can act as a systemic muscle relaxant within 4 weeks prior to screening
- Participants who have received anticoagulants, anti-platelet agents, or systemic NSAIDs within 7 days prior to administration of investigational products (however, low-dose aspirin [325 mg/day or less] administered for antithrombotic purposes is acceptable)
- Participants who have participated in other clinical trials of a drug/medical device within 30 days from participating in this clinical study and have been administered/treated with the investigational product/medical device
- Participants deemed ineligible for this study for other reasons based on the investigator's judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Double-blind, Randomized, Parallel, Active-controlled Phase III Trial to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection INI101 Compared to BOTOX® in Subjects With Moderate to Severe Glabellar Lines.
To evaluate the efficacy and safety of botulinum toxin type A for injection INI101 compared to BOTOX® in subjects with moderate to severe glabellar lines.
- Conditions
- Glabellar Lines
- Being tested
- Botulinum Toxin Type A Injection [INI101], Botulinum Toxin Type A Injection [Botox]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A Injection [INI101]Drug
Single administration, Day 0, 20 units
Botulinum Toxin Type A Injection [Botox]Drug
Single administration, Day 0, 20 units
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A (INI101) | Experimental | Not described Receives: Drug: Botulinum Toxin Type A Injection [INI101] |
| Botulinum toxin type A (BOTOX®) | Active comparator | Not described Receives: Drug: Botulinum Toxin Type A Injection [Botox] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment
Investigator assessed the subject's glabellar lines 'At maximum frown' on a 4-point facial wrinkle scale (FWS) after 4 weeks of the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
Measured: Baseline to week 4
Secondary outcomes (6)
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment
Investigator assessed the subject's glabellar lines 'At maximum frown' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
Measured: Baseline to week 8, 12, 16
Improvement rate of glabellar lines at rest according to the investigator's on-site assessment
Investigator performed on-site assessment of the subject's glabellar lines 'At rest' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
Measured: Baseline to week 4, 8, 12, 16
Improvement rate of glabellar lines at maximum frown according to the independent assessor's photo assessment
Independent assessor assessed the subject's glabellar lines 'At maximum frown' ' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation. An independent assessor separately conducted the FWS assessment subsequently based on the photographs taken.
Measured: Baseline to week 4, 8, 12, 16
Improvement rate of glabellar lines at rest according to the independent assessor's photo assessment
Independent assessor assessed the subject's glabellar lines 'At rest' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation. An independent assessor separately conducted the FWS assessment subsequently based on the photographs taken.
Measured: Baseline to week 4, 8, 12, 16
Improvement rate of glabellar lines as assessed by the subject
Subjects assessed their glabellar lines at each time point after the administration of the investigational product compared to baseline.
Measured: Baseline to week 4, 8, 12, 16
Subject's satisfaction
Subject's satisfaction score for the improvement of glabellar lines was investigated at each time point after the administration of the investigational product compared to before administration.
Measured: Baseline to week 4, 8, 12, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start27 May 2021
- Primary completion30 Jan 2022
- Study completion5 Mar 2022
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- INIBIO Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622004
- Sponsor's protocol ID
- NI101-PLN-CO-002
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Parallel, Active-controlled Phase III Trial to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection INI101 Compared to BOTOX® in Subjects With Moderate to Severe Glabellar Lines.
- ClinicalTrials.gov ID
- NCT07622004
- Acronym / sponsor ID
- NI101-PLN-CO-002
- Conditions
- Glabellar Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- INIBIO Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 May 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 5 Mar 2022 (actual)
- First posted
- 2 Jun 2026 (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.
To evaluate the efficacy and safety of botulinum toxin type A for injection INI101 compared to BOTOX® in subjects with moderate to severe glabellar lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin type A (INI101) | Experimental | Drug: Botulinum Toxin Type A Injection [INI101] |
| Botulinum toxin type A (BOTOX®) | Active comparator | Drug: Botulinum Toxin Type A Injection [Botox] |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult male or female participants aged between 19 and 65 years old.
- Participants whose glabellar line score was 2 (moderate) or higher of glabellar line score at maximum frown based on the investigator's judgment at screening and randomization.
- Participants who voluntarily gave a consent in writing to participate in the clinical study with full knowledge of details of the study after listening to them.
- Participants who can understand and comply with the procedures and visit schedules of the study.
Key exclusion criteria (8 listed)
- Systemic neuromuscular junction disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, hereditary motor neuropathy, etc.)
- History of blepharoplegia or ptosis
- Prominent facial asymmetry
- Glabellar lines that are physically difficult to be improved, such as the case where the lines are not removed by hands
- Participants who have received any drugs that can act as a systemic muscle relaxant 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 |
|---|---|---|
| Botulinum Toxin Type A Injection [INI101]Single administration, Day 0, 20 units | Drug | Botulinum toxin type A (INI101) |
| Botulinum Toxin Type A Injection [Botox]Single administration, Day 0, 20 units | Drug | Botulinum toxin type A (BOTOX®) |
Primary outcome
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment
Time frame: Baseline to week 4
Investigator assessed the subject's glabellar lines 'At maximum frown' on a 4-point facial wrinkle scale (FWS) after 4 weeks of the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
6 secondary outcomes
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment
Time frame: Baseline to week 8, 12, 16
Improvement rate of glabellar lines at rest according to the investigator's on-site assessment
Time frame: Baseline to week 4, 8, 12, 16
Improvement rate of glabellar lines at maximum frown according to the independent assessor's photo assessment
Time frame: Baseline to week 4, 8, 12, 16
Improvement rate of glabellar lines at rest according to the independent assessor's photo assessment
Time frame: Baseline to week 4, 8, 12, 16
Improvement rate of glabellar lines as assessed by the subject
Time frame: Baseline to week 4, 8, 12, 16
Subject's satisfaction
Time frame: Baseline to week 4, 8, 12, 16
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 3 Jun 2026.
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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 Type A Injection [INI101] and Botulinum Toxin Type A Injection [Botox] in people with Glabellar Lines, run by INIBIO Co., Ltd. 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 8 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 3 Jun 2026. 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?
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment (time frame: Baseline to 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 3 Jun 2026.