Glabellar LinesPhase 2NCT05298449
Phase 2 of HU-045 in Glabellar Lines
A Phase 2 study testing HU-045 and Xeomin® in people with Glabellar Lines, run by Huons Co., Ltd. at 1 site in South Korea.
Trial summary
A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HU-045 and Xeomin® in Patients With 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?
- HU-045 and Xeomin®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Mar 2022to 25 Apr 2023
- Phase
- Phase 2
- 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
- 2(Moderate) and/or above of Facial Wrinkle Scale (FWS) score at frown in investigator's live assessment.
- Subject who signed voluntarily in informed consent form and fully understood about this clinical trial.
Who cannot join
- Subject who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
- Infection, dermatological condition or scar at the treatment injection sites
- Subject who has marked facial asymmetry
- History of facial nerve palsy or eyebrow/eyelid ptosis
- History of surgical procedures affecting on the lines of forehead and/or middle of the forehead areas
- History of malignant tumor within 5 years (except for basal cell carcinoma
Show all 20Show fewer
- Any disease and condition that, in the view of the investigator, would interfere with study participation
- Subject who has been treated with any botulinum toxin drug within 6 months
- Subject who takes skeletal muscle relaxants,
- Subject who takes a anticoagulant, antiplatelet, NSAIDs, Vitamin E of over 1,000IU/day (except for low dose aspirin)
- From screening,
- Subject who have positive results of HIV, Syphilis, HBV, HCV
- Drug Hypersensitivity
- Subjects who have hypersensitivity reaction to investigational drug or local anesthetics
- History of Anaphylaxis or severe combined allergy disease
- Subject who has physically untreatable glabellar lines like that can't be spread out even if someone forces it to spread out
- Pregnant and lactating women
- Fertile women and men who have plans to pregnancy and who do not agree to appropriate contraception.
- Participant who has been treated with any investigational drug within 30 days from screening
- Subject 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: A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HU-045 and Xeomin® in Patients With Moderate to Severe Glabellar Lines
A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HU-045 and Xeomin® in Patients With Moderate to Severe Glabellar Lines
- Conditions
- Glabellar Lines
- Being tested
- HU-045, Xeomin®
- Keywords
- Glabellar Lines, HU-045, Huons, HuonsBioPharma, Botulinum toxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HU-045Drug
Also called IncobotulinumtoxinA
HU-045 is a medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It should be reconstituted with sterile, preservative-free 0.9% saline before use.
White powder
Xeomin®Drug
Also called IncobotulinumtoxinA
Xeomin® is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It should be reconstituted with sterile, preservative-free 0.9% saline before use.
| Study group | Role | What they receive |
|---|---|---|
| HU-045 group | Experimental | HU-045 Injection group will receive intramuscular injection of HU-045 to a total of 5 glabellar line sites 4 U/0.1ml each.
HU-045 will be reconstituted from a powder into liquid form by adding 2.5cc of 0.9% sterile saline to the vial, and appropriate volumes will be administered. Receives: Drug: HU-045 |
| Xeomin® group | Active comparator | Xeomin® Injection group will receive intramuscular injection of Xeomin® to a total of 5 glabellar line sites 4 U/0.1ml each.
Xeomin® will be reconstituted from a powder into liquid form by adding 2.5cc of 0.9% sterile saline to the vial, and appropriate volumes will be administered. Receives: Drug: Xeomin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants whose glabellar lines at maximal frown are improved
Investigators will assess participant's glabellar lines with Facial Wrinkle Scale(FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe.
Only the participants whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.
Measured: Week4
Secondary outcomes (4)
Percentage of participants whose glabellar lines at maximal frown are improved
Investigators will assess participant's glabellar lines with Facial Wrinkle Scale(FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe.
Only the participants whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.
Measured: Week8, Week12
Percentage of participants whose glabellar lines at resting are improved
Investigators will assess participant's glabellar lines with Facial Wrinkle Scale(FWS) at resting; 0=none, 1=mild, 2=moderate or 3=severe.
Only the participants whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.
Measured: Week4, Week8, Week12
Subject's satisfaction rate after injection
Participants will rate their overall satisfaction by answering the question on a Questionnaire using 7-point scale. 6 and/or above grade will be defined as the participant is satisfied about their glabellar lines.
Measured: Week4, Week8, Week12
Percentage of subjects who assessed their Glabellar Lines are improved ≥ 2-grade
Subjects will assess their Galbellar Lines with a 9-point scale from -4 to 4.
Measured: Week4, Week8, Week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start28 Mar 2022
- Primary completion7 Nov 2022
- Study completion25 Apr 2023
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298449
- Sponsor's protocol ID
- HU-045_P2
- Status last verified
- Jul 2023
- First submitted
- 16 Mar 2022
- Last updated
- 5 Jul 2023
- 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 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HU-045 and Xeomin® in Patients With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT05298449
- Acronym / sponsor ID
- HU-045_P2
- Conditions
- Glabellar Lines
- Keywords
- Glabellar Lines, HU-045, Huons, HuonsBioPharma, Botulinum toxin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 28 Mar 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, Active-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HU-045 and Xeomin® in Patients 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 |
|---|---|---|
| HU-045 group | Experimental | Drug: HU-045HU-045 Injection group will receive intramuscular injection of HU-045 to a total of 5 glabellar line sites 4 U/0.1ml each. HU-045 will be reconstituted from a powder into liquid form by adding 2.5cc of 0.9% sterile saline to the vial, and appropriate volumes will be administered. |
| Xeomin® group | Active comparator | Drug: Xeomin®Xeomin® Injection group will receive intramuscular injection of Xeomin® to a total of 5 glabellar line sites 4 U/0.1ml each. Xeomin® will be reconstituted from a powder into liquid form by adding 2.5cc of 0.9% sterile saline to the vial, and appropriate volumes will be administered. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 2(Moderate) and/or above of Facial Wrinkle Scale (FWS) score at frown in investigator's live assessment.
- Subject who signed voluntarily in informed consent form and fully understood about this clinical trial.
Key exclusion criteria (20 listed)
- Subject who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
- Infection, dermatological condition or scar at the treatment injection sites
- Subject who has marked facial asymmetry
- History of facial nerve palsy or eyebrow/eyelid ptosis
- History of surgical procedures affecting on the lines of forehead and/or middle of the forehead areas
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 |
|---|---|---|
| HU-045Also: IncobotulinumtoxinAHU-045 is a medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It should be reconstituted with sterile, preservative-free 0.9% saline before use. White powder | Drug | HU-045 group |
| Xeomin®Also: IncobotulinumtoxinAXeomin® is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It should be reconstituted with sterile, preservative-free 0.9% saline before use. | Drug | Xeomin® group |
Primary outcome
Percentage of participants whose glabellar lines at maximal frown are improved
Time frame: Week4
Investigators will assess participant's glabellar lines with Facial Wrinkle Scale(FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe. Only the participants whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.
4 secondary outcomes
Percentage of participants whose glabellar lines at maximal frown are improved
Time frame: Week8, Week12
Percentage of participants whose glabellar lines at resting are improved
Time frame: Week4, Week8, Week12
Subject's satisfaction rate after injection
Time frame: Week4, Week8, Week12
Percentage of subjects who assessed their Glabellar Lines are improved ≥ 2-grade
Time frame: Week4, Week8, Week12
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 5 Jul 2023.
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 2 study testing HU-045 and Xeomin® in people with Glabellar Lines, run by Huons 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 2 inclusion and 20 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 5 Jul 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of participants whose glabellar lines at maximal frown are improved (time frame: Week4). 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 5 Jul 2023.