Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 19 to 65

See if HU-045 works for moderate to severe glabellar lines

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

Run by Huons Biopharma · NCT07870694 · Data updated 2026-11-12

This study tests HU-045 against Xeomin® in adults with moderate to severe glabellar lines to see which treatment works better and is safe.

More Glabellar Lines trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages19 Years to 65 Years
SexAll
Enrollment390 (estimated)
SponsorHuons Biopharma
Industry-sponsored
Locations1 site (Seoul)
StatusRecruiting
StartedSeptember 3, 2026
Main results expectedMay 2027
Study endsAugust 2027
Registry record updatedOctober 13, 2026
Trial IDNCT07870694 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 19–65 with moderate to severe glabellar lines at maximum frown and who can comply with visit schedules.

Probably not a fit

Individuals without a meaningful response to treatment or with contraindicating conditions may not experience skin improvements.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, double-blind, randomized, parallel, active-controlled Phase 3 trial comparing HU-045 with Xeomin® in adults aged 19–65 who have moderate to severe glabellar lines. Participants are randomly assigned to receive HU-045 or Xeomin®, and neither participants nor investigators know which treatment is given. The study aims to evaluate efficacy and safety over a defined follow-up period, using standardized facial line assessments. Key eligibility requires stable health status, ability to attend visits, and no history of hypersensitivity to study products. Exclusion criteria include neuromuscular disorders, active skin conditions at injection sites, and certain structural facial features that could affect outcomes.

Why it matters

Potential benefit: If successful, participants could experience improvements in the appearance of glabellar lines with a treatment that may offer a favorable safety profile.

How similar studies have gone: Previous studies in similar botulinum toxin products have shown benefit for glabellar lines, though results can vary by product and patient.

Who can join: the full rules

Show full inclusion / exclusion criteria
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:

* 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.

Where it's running

  • Chung-Ang University Hospital
    Seoul, South Korea
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Combination of two botulinum toxins for upper facial lines in adults

    This study tests whether a single treatment that combines trenibotulinumtoxinE with onabotulinumtoxinA can improve moderate to severe upper facial lines in adults.

    Recruiting at 21 sites Phase 2 AbbVie · Birmingham, Alabama and 20 other locations · NCT07871513

  • Corabotase for glabellar lines in adults

    A single-dose injection of corabotase (IPN10200) or placebo will be tested in adults with moderate to severe wrinkle-like lines between the eyebrows to see if it improves the lines and remains safe.

    Recruiting at 2 sites Phase 3 Ipsen · Guangzhou, Guangdong and 8 other locations · NCT07779252

  • Eveotox injections for moderate to severe glabellar lines

    This trial tests whether Eveotox injections can reduce moderate to severe glabellar lines in adults aged 18–65 compared with Botox and a placebo.

    Recruiting at 15 sites Phase 3 JHM BioPharma (Tonghua) Co. , Ltd. · Beijing, Beijing Municipality and 14 other locations · NCT06937944

  • Head-to-Head Comparison of BoNT-A Treatments for Glabellar Lines

    A multicenter, triple-blind study will test all FDA-approved Botulinum Neurotoxin Type A products to see which best reduces glabellar frown lines and lasts the longest.

    Recruiting at 3 sites Phase 4 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam and 2 other locations · NCT06448676

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.