Glabellar LinesPhase 3NCT07870694
To Evaluate HU-045 With Moderate to Severe Glabellar Lines
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
- 390 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Sep 2026to Aug 2027
- Phase
- Phase 3
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
- Adults aged 19 to 65 years, inclusive, as of the date of written informed consent.
- Subjects who have a glabellar line severity score of 2 (moderate) or greater, as assessed by the investigator, when maximizing frown (frowning) at the screening and randomization visits.
- Subjects who are able to comply with the visit schedule according to the clinical trial procedures.
- Subjects who signed voluntarily in informed consent form and fully understood about this clinical trial.
Who cannot join
- Subjects with a known history of allergy or hypersensitivity to the investigational product or any of its components (or ingredients).
- Subjects with a systemic neuromuscular junction disorder that may affect neuromuscular function. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
- Subjects with an infection or skin disease at the treatment injection sites.
- Subjects with structural or physical facial features (or conditions) that may hinder or prevent improvement (facial nerve palsy or eyebrow/eyelid ptosis, marked facial asymmetry etc.)
- Subjects who have received drugs with systemic muscle relaxant action within 4 weeks of screening
- Subjects who have received botulinum toxin products within 24 weeks prior to screening, or who are expected to receive botulinum toxin treatment during the study.
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- Subjects who have received an investigational product or medical device in another clinical trial within 4 weeks prior to screening, or who are planning to participate in another clinical trial (excluding non-interventional observational studies).
- Subjects with a history of, or planned, surgery or procedures in the glabellar or forehead region that may affect the efficacy evaluation during the following period
- Collagen dermal fillers within 16 weeks prior to screening
- Permanent soft tissue augmentation, face Lifting, implant, or fat grafting within 24 weeks prior to screening
- Hyaluronic acid dermal fillers, dermal resurfacing, chemical or mechanical peeling, skin peeling, or dermal photorejuvenation within 52 weeks prior to screening
- Dermal fillers other than hyaluronic acid or collagen, or nonpermanent soft tissue fillers within 104 weeks prior to screening
- Subjects who are planning to undergo facial aesthetic procedures or surgeries (such as dermal fillers, dermal photorejuvenation, chemical or mechanical peeling, facial plastic surgery, etc.) during the study
- Subjects who have received retinoid products (such as isotretinoin, alitretinoin, etc.) during the following period
- Oral or other systemic formulations within 24 weeks prior to screening
- Topical formulations applied to the face within 12 weeks prior to screening
- Pregnant and lactating women
- Subjects who are planning to become pregnant during the study, or who do not agree to use medically acceptable methods of contraception.
- Subjects with any comorbid conditions or diseases that, in the opinion of the investigator, would interfere with study participation (such as malignant tumors or immunodeficiency)
- Subjects who have received anticoagulants, antiplatelets, or systemic non-steroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to administration of the investigational product (low-dose aspirin of 325 mg/day or less administered for antithrombotic purposes is permitted).
- Subjects who has physically untreatable glabellar lines like that can't be spread out even if someone forces it to spread out
- Subjects who are not eligible for this study based on investigator's judgement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chung-Ang University Hospital
Seoul
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. 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 | 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® | 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 as Assessed by the Investigator
Investigators will assess participant's glabellar lines with Facial Wrinkle Scale(FWS) at maximal frown; 0=none, 1=mild, 2=moderate or3=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 (6)
Percentage of Participants Whose Glabellar Lines at Maximal Frown Are Improved as Assessed by the Investigator
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: Week 8, Week 12, and Week 16
Percentage of Participants Whose Glabellar Lines at Rest Are Improved as Assessed by the Investigator
Investigators will assess participant's glabellar lines with Facial Wrinkle Scale(FWS) at rest; 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: Week 4, Week 8, Week 12, and Week 16
Percentage of Participants Whose Glabellar Lines at Maximal Frown Are Improved Based on Independent Evaluators' Photographic Assessment
Independent evaluators will assess participant's glabellar lines using photographs taken at rest with Facial Wrinkle Scale (FWS); 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: Week 4, Week 8, Week 12, and Week 16
Percentage of Participants Whose Glabellar Lines at Rest Are Improved Based on Independent Evaluators' Photographic Assessment
Independent evaluators will assess participant's glabellar lines using photographs taken at rest with Facial Wrinkle Scale (FWS); 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: Week 4, Week 8, Week 12, and Week 16
Percentage of Participants Whose Glabellar Lines are Improved as Assessed by Participants
Participants will evaluate the improvement of their glabellar lines compared to baseline using the Subject Global Assessment (SGA) scale; -4 = very markedly worse to +4 = completely improved. Only the participants who achieve a score of +2 or higher will be defined as having improved glabellar lines.
Measured: Week 4, Week 8, Week 12, and Week 16
Percentage of Participants Satisfied with Treatment
Participants will evaluate their overall satisfaction with the treatment using the Participant Satisfaction (PS) scale; 1 = very dissatisfied to 7 = very satisfied. Only the participants who achieve a satisfaction score of 6 or higher will be defined as satisfied with the treatment.
Measured: Week 4, Week 8, Week 12, and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start3 Sep 2026
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (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
- 390 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
- NCT07870694
- Sponsor's protocol ID
- HU-045_P3_GL
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No