Glabellar LinesPhase 1NCT04944953
To Compare the Safety and Efficacy of "HG-102" With Botox® in the Improvement of Moderate to Severe Glabellar Lines.
A Phase 1 study testing Botulinum Toxin Type A Injection [Botox] and Botulinum toxin type A injection [HG-102] in people with Glabellar Lines, run by Hugel at 1 site in South Korea.
Trial summary
To compare the safety and efficacy of "HG-102" with Botox® in the improvement of moderate to 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?
- Botulinum Toxin Type A Injection [Botox] and Botulinum toxin type A injection [HG-102]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jun 2021to 16 Dec 2021
- Phase
- 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 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 at screening visit.
- Patients who voluntarily sign the informed consent.
- Patients who can comply with the study procedures and visit schedule.
Who cannot join
- Patients with infection, skin disorders, or scars at the glabellar region.
- Patients with facial palsy or the symptoms of blepharoptosis.
- Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception.
- Subjects who are not eligible for this study based on investigator's judgement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blinded, Randomized, Active Control, Single Center-designed, Phase I Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of "HG-102" Compared to Botox® in Subjects With Moderate to Severe Glabellar Lines
To compare the safety and efficacy of "HG-102" with Botox® in the improvement of moderate to severe glabellar lines.
Read the detailed description
Double-blinded, Randomized, Active control, Single center-designed, Phase I clinical trial to evaluate the safety and efficacy for improvement of Glabellar Lines of "HG-102" compared to Botox® in subjects with moderate to severe Glabellar Lines
- Conditions
- Glabellar Lines
- Being tested
- Botulinum Toxin Type A Injection [Botox], Botulinum toxin type A injection [HG-102]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A Injection [Botox]Drug
Also called Botox®
Single administration, Day 0, 20 units
Botulinum toxin type A injection [HG-102]Drug
Also called HG-102
Single administration, Day 0, 20 units
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A(Botox®) | Active comparator | Botulinum toxin type A(Botox®) 100 Unit Receives: Drug: Botulinum Toxin Type A Injection [Botox] |
| Botulinum toxin type A(HG-102) | Experimental | Botulinum toxin type A(HG-102) 100 Unit Receives: Drug: Botulinum toxin type A injection [HG-102] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event and adverse drug reaction incidence rates
Measured: Baseline to week 16
Clinically-relevant changes in vital signs, physical exam, and laboratory testing assessed by medical personnel
Measured: 16 weeks (during the clinical trial)
Secondary outcomes (8)
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, 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 maximum frown with investigator's photo assessment at 4, 8, 12, 16 weeks post injection
Measured: Baseline to week 4, 8, 12, 16
Responder rate of improvement in glabellar lines with Physician's rating line severity
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
Changes in grade by physician's rating line severity for glabellar lines
Changes in grade(range from 0(None) to 3(Severe)) by physician's rating line severity for glabellar lines at each visit compared to baseline
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
Subject's satisfaction rate
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
The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS)
The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS) at immediately and about 30 minutes post injection (severity range is from 1(no pain) to 5(unbearable pain))
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start11 Jun 2021
- Primary completion2 Sep 2021
- Study completion16 Dec 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944953
- Sponsor's protocol ID
- HG-BOT102GL-PI-01
- Status last verified
- May 2022
- First submitted
- 11 Jun 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Double-blinded, Randomized, Active Control, Single Center-designed, Phase I Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of "HG-102" Compared to Botox® in Subjects With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT04944953
- Acronym / sponsor ID
- HG-BOT102GL-PI-01
- Conditions
- Glabellar Lines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- HugelIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 30 Jun 2021 (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 compare the safety and efficacy of "HG-102" with Botox® in the improvement of moderate to severe glabellar lines.
Detailed description
Double-blinded, Randomized, Active control, Single center-designed, Phase I clinical trial to evaluate the safety and efficacy for improvement of Glabellar Lines of "HG-102" 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(Botox®) | Active comparator | Drug: Botulinum Toxin Type A Injection [Botox]Botulinum toxin type A(Botox®) 100 Unit |
| Botulinum toxin type A(HG-102) | Experimental | Drug: Botulinum toxin type A injection [HG-102]Botulinum toxin type A(HG-102) 100 Unit |
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 at screening visit.
- Patients who voluntarily sign the informed consent.
- Patients who can comply with the study procedures and visit schedule.
Key exclusion criteria (4 listed)
- Patients with infection, skin disorders, or scars at the glabellar region.
- Patients with facial palsy or the symptoms of blepharoptosis.
- Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception.
- Subjects who are not eligible for this study based on investigator's judgement.
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 [Botox]Also: Botox®Single administration, Day 0, 20 units | Drug | Botulinum toxin type A(Botox®) |
| Botulinum toxin type A injection [HG-102]Also: HG-102Single administration, Day 0, 20 units | Drug | Botulinum toxin type A(HG-102) |
Primary outcome
Adverse event and adverse drug reaction incidence rates
Time frame: Baseline to week 16
Clinically-relevant changes in vital signs, physical exam, and laboratory testing assessed by medical personnel
Time frame: 16 weeks (during the clinical trial)
8 secondary outcomes
Responder rate of improvement in glabellar lines with Physician's rating line severity
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
Responder rate of improvement in glabellar lines with Physician's rating line severity
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
Changes in grade by physician's rating line severity for glabellar lines
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
Subject's satisfaction rate
Time frame: Baseline to week 4, 8, 12, 16
The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS)
Time frame: Baseline
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.
Related trials for Glabellar Lines
RecruitingPhase 2
A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines
Upper Facial Lines, Glabellar Lines
Active, not recruitingPhase 1
A Study to Evaluate Sequential Administration of Injections of AGN-151586 Followed by BOTOX in Adult Participants for Treatment of Glabellar Lines
Glabellar Lines
RecruitingPhase 3
To Evaluate HU-045 With Moderate to Severe Glabellar Lines
Glabellar Lines
Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Moderate to Severe Glabellar Lines
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 1 study testing Botulinum Toxin Type A Injection [Botox] and Botulinum toxin type A injection [HG-102] 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 3 inclusion and 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse event and adverse drug reaction incidence rates (time frame: Baseline to week 16). The study lists 2 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 24 May 2022.