Glabellar LinesPhase 3NCT05801146
Evaluate the Safety and Efficacy of HG102 as Compared to Botox® in Subject With Moderate to Severe Glabellar Lines
A Phase 3 study testing Botulinum Toxin Type A Injection [HG102] and Botulinum Toxin Type A Injection [Botox] in people with Glabellar Lines, run by Hugel at 1 site in South Korea.
Trial summary
To evaluate the efficacy and safety of HG102 for moderate to severe Glabellar Lines, non-inferiority compared to Botox® was confirmed and safety was evaluated. 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?
- Botulinum Toxin Type A Injection [HG102] 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
- 272 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jan 2024to Oct 2025
- 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
- Subjects that fit all of the criteria below were selected for this clinical trial.
- Male and female adults from 19 to 65 years old at the time of screening
- Person with moderate or severe glabellar lines and have received Grade 2-3 according to Physician's Rating Line Severity at maximum frown
- Person who understands and can comply to the process and visiting schedule of this clinical study
- Person who gave spontaneous written consent to participate in this clinical study
Who cannot join
- Subjects that fit any of the criteria below were excluded from this clinical trial.
- Person with infection, skin disease, or scar on forehead
- Person with symptoms of facial palsy or blepharoptosis
- Person with allergies or hypersensitive reaction history to the ingredients in the investigational product (botulinum toxin formula, serum albumin, etc.)
- Person who were administered with similar medication within 12 weeks (botulinum toxin type A medication) or 16 weeks (botulinum toxin type B medication)
- Pregnant and breast-feeding women, men and women in the childbearing age who are planning to get pregnant during the clinical study period, or do not agree to the suitable contraceptive methods
- Person who participated in another clinical trial, or were given medication for other clinical trials within 4 weeks from screening of 5 times the half-life, which period may be longer
- Other person who the investigator judges as inappropriate for the clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Compare the Efficacy and Safety of HG102 Versus Botox® in Subjects With Moderate to Severe Glabellar Lines
To evaluate the efficacy and safety of HG102 for moderate to severe Glabellar Lines, non-inferiority compared to Botox® was confirmed and safety was evaluated.
- Conditions
- Glabellar Lines
- Being tested
- Botulinum Toxin Type A Injection [HG102], 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 [HG102]Drug
Also called HG102
Single administration, Day 0, 20 units
Botulinum Toxin Type A Injection [Botox]Drug
Also called Botox®
Single administration, Day 0, 20 units
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A(HG102) | Experimental | Not described Receives: Drug: Botulinum Toxin Type A Injection [HG102] |
| 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.
Responder rate of improvement in glabellar lines with Physician's rating line severity
Improvement rate of glabellar lines at maximum frown with Physician's rating line severity at 4 weeks post injection
Measured: Baseline to week 4
Secondary outcomes (6)
Responder rate of improvement in glabellar lines with Physician's rating line severity
Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 8, 12, 16 weeks post injection
Measured: Baseline to week 8, 12, 16
Responder rate of improvement in glabellar lines with investigator's photo assessment
Improvement rate of glabellar lines at rest with Physician's rating line severity at 4, 8, 12, 16 weeks post injection
Measured: Baseline to week 4, 8, 12, 16
Responder rate of improvement in glabellar lines with investigator's photo assessment
Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16 weeks post injection
Measured: Baseline to week 4, 8, 12, 16
Independent photo evaluator-rated improvement rate of glabellar lines at rest
Measured: Baseline to week 4, 8, 12, 16
Responder rate of improvement in glabellar lines with Subject's improvement assessment
Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16 weeks post injection
Measured: Baseline to week 4, 8, 12, 16
Participant-rated satisfaction after treatment
Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection
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 posted6 Apr 2023
- Study start4 Jan 2024
- Primary completionMar 2025 (estimated)
- Study completionOct 2025 (estimated)
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
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801146
- Sponsor's protocol ID
- HG-102GL-PIII-01
- Status last verified
- Jan 2024
- First submitted
- 24 Mar 2023
- Last updated
- 16 Jan 2024
- 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 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Compare the Efficacy and Safety of HG102 Versus Botox® in Subjects With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT05801146
- Acronym / sponsor ID
- HG-102GL-PIII-01
- Conditions
- Glabellar Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- HugelIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 6 Apr 2023 (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 HG102 for moderate to severe Glabellar Lines, non-inferiority compared to Botox® was confirmed and safety was evaluated.
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(HG102) | Experimental | Drug: Botulinum Toxin Type A Injection [HG102] |
| 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects that fit all of the criteria below were selected for this clinical trial.
Key exclusion criteria (8 listed)
- Subjects that fit any of the criteria below were excluded from this clinical trial.
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 [HG102]Also: HG102Single administration, Day 0, 20 units | Drug | Botulinum toxin type A(HG102) |
| Botulinum Toxin Type A Injection [Botox]Also: Botox®Single administration, Day 0, 20 units | Drug | Botulinum toxin type A(Botox®) |
Primary outcome
Responder rate of improvement in glabellar lines with Physician's rating line severity
Time frame: Baseline to week 4
Improvement rate of glabellar lines at maximum frown with Physician's rating line severity at 4 weeks post injection
6 secondary outcomes
Responder rate of improvement in glabellar lines with Physician's rating line severity
Time frame: Baseline to week 8, 12, 16
Responder rate of improvement in glabellar lines with investigator's photo assessment
Time frame: Baseline to week 4, 8, 12, 16
Responder rate of improvement in glabellar lines with investigator's photo assessment
Time frame: Baseline to week 4, 8, 12, 16
Independent photo evaluator-rated improvement rate of glabellar lines at rest
Time frame: Baseline to week 4, 8, 12, 16
Responder rate of improvement in glabellar lines with Subject's improvement assessment
Time frame: Baseline to week 4, 8, 12, 16
Participant-rated satisfaction after treatment
Time frame: Baseline to week 4, 8, 12, 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- 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.
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 [HG102] and Botulinum Toxin Type A Injection [Botox] 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 5 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: status not confirmed, as of the sponsor's last update on 16 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cho Long Park (+82-2-6966-1654, clpark@hugel.co.kr), or a site near the patient. 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 line severity (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 16 Jan 2024.