Glabellar LinesPhase 3NCT06205797
To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III)
A Phase 3 study testing HU-045 and Xeomin® in people with Glabellar Lines, run by Huons Biopharma 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 yearsHealthy volunteers can take part
- 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
- 312 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jun 2024to 31 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19 Years to 65 Years(Adult, Older Adult)
- 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.)
- History of bleeding disorder
- 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
Show all 19Show fewer
- History of malignant tumor within 5 years (except for basal cell carcinoma
- Any disease and condition that, in the view of the investigator, would interfere with study participation
- History of alcohol or drug addiction
- Subject who has been treated with any botulinum toxin drug within 6 months
- Persons who have received the following drugs with systemic muscle relaxant action within 4 weeks of screening
- Subjects taking more than 1,000 IU/day of anticoagulants, antiplatelet agents, NSAIDs, or vitamin E within 7 days prior to administration of the investigational drug (excluding low-dose aspirin)
- A person who has received a retinoid series of medications during the following period as of the time of screening
- 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 F- ertile 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.
South Korea1 site, 1 recruiting
- Recruiting
Kangbuk Samsung Hospital
Seoul
Kim, 82-2-2001-2241, susini@naver.com
About this study
Official title: A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HU-045 Compared to Xeomin® in Adult Patients With Moderate or 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®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HU-045Drug
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
Other Names:
IncobotulinumtoxinA
Xeomin®Drug
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.
Other Names:
IncobotulinumtoxinA
| 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, Week16
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, Week16
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; (1 = very unsatisfied, 2 = un satisfied, 3 = slightly dissatisfied, 4 = average, 5 = slightly satisfied, 6 = Satisfaction, 7 = very satisfied
Measured: Week4, Week8, Week12, Week16
Percentage of subjects who assessed their Glabellar Lines are improved ≥ +2 grade
Subjects will assess their glabellar Lines with a 9 point scale from -4 to +4;(+4 = 100% improvement, +3 = 75% improvement, +2 = 50% improvement, +1 = 25% improvement, 0 = no change, -1 = 25% worse, -2 = 50% worse, -3 = 75% worse, -4 = 100% worse
Measured: Week4, Week8, Week12, Week16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start20 Jun 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Mar 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
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huons Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205797
- Sponsor's protocol ID
- HU-045_P3
- Status last verified
- Oct 2024
- First submitted
- 4 Jan 2024
- Last updated
- 3 Oct 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 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HU-045 Compared to Xeomin® in Adult Patients With Moderate or Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT06205797
- Acronym / sponsor ID
- HU-045_P3
- Conditions
- Glabellar Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Huons BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 16 Jan 2024 (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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 Years to 65 Years(Adult, Older Adult)
- 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 (19 listed)
- Subject who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
- History of bleeding disorder
- 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
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-045HU-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 Other Names: IncobotulinumtoxinA | Drug | HU-045 group |
| Xeomin®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. Other Names: IncobotulinumtoxinA | 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, Week16
Percentage of participants whose glabellar lines at resting are improved
Time frame: Week4, Week8, Week12, Week16
Subject's satisfaction rate after injection
Time frame: Week4, Week8, Week12, Week16
Percentage of subjects who assessed their Glabellar Lines are improved ≥ +2 grade
Time frame: Week4, Week8, Week12, Week16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 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 HU-045 and Xeomin® in people with Glabellar Lines, run by Huons Biopharma 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 19 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 3 Oct 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 Saeroarum Han (82-70-7492-6032, saeroarum@huonsbiopharma.com), or a site near the patient. 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 3 Oct 2024.