RecruitingNCT07870694Updated Oct 13, 2026

To Evaluate HU-045 With Moderate to Severe Glabellar Lines

A Phase 3 interventional study of HU-045 and Xeomin® in Glabellar Lines, sponsored by Huons Biopharma. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Huons Biopharma (part of Huons Global) · Phase 3, Interventional, and Treatment

From the registry’s dates

Started Sep 2026; still recruiting 1 month later.

Updated Oct 13, 2026Newly registeredGo to Updates ↓

Phase: Phase 3
Study type: Interventional
Enrollment: 390
Allocation: Randomized
Ages: 19 Years to 65 Years
Sex: All

Study 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

Conditions studied

Glabellar Lines

In context

Lead sponsor

Huons Biopharma is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Browse Huons Biopharma studies →All Huons Global studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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
1. Collagen dermal fillers within 16 weeks prior to screening
2. Permanent soft tissue augmentation, face Lifting, implant, or fat grafting within 24 weeks prior to screening
3. Hyaluronic acid dermal fillers, dermal resurfacing, chemical or mechanical peeling, skin peeling, or dermal photorejuvenation within 52 weeks prior to screening
4. Dermal fillers other than hyaluronic acid or collagen, or nonpermanent soft tissue fillers within 104 weeks prior to screening
5. 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
1. Oral or other systemic formulations within 24 weeks prior to screening
2. 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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 390 participants (estimated)

Study arms

Experimental
HU-045
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.
Drug: HU-045
Active comparator
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.
Drug: Xeomin®

Interventions

DrugHU-045
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
DrugXeomin®
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

What researchers measure

Primary outcomes

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.
Time frame: Week4

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 4, Week 8, Week 12, and Week 16

Study locations

1 of 1 sites recruiting

Chung-Ang University Hospital
Seoul, South Korea
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

1 registry update since Sep 25, 2026

Registered

First appeared on the registry. No changes since

Oct 13, 2026

Show all 1 update

Oct 13, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07870694
Lead sponsor: Huons Biopharma
Responsible party: Sponsor
First posted: Oct 13, 2026
Start date: Sep 3, 2026
Primary completion: May 2027 (estimated)
Completion: Aug 2027 (estimated)
Last update: Oct 13, 2026

Study contacts

Saeroarum Han

Contact

saeroarum@huonsbiopharma.com

82-70-7492-6032

Minji Han

Contact

huonshmj@huonsbiopharma.com

82-70-7492-6074

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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