ClinicalTrials.gg
CompletedNCT05380154Updated May 24, 2022

Efficacy and Safety Assessment of Botulax® and BOTOX® for Improvement of Glabellar Lines.

A Phase 3 interventional study of Botulinum Toxin A type for injection (Botulax®) and Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®) in Glabellar Lines, sponsored by Hugel. Completed at 1 site in South Korea. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-24.

Sponsored by Hugel · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years after the study started (first participant enrolled May 2017, registered May 2022).
Phase
Phase 3
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study is a phase 3 clinical trial of multi-center, random, blinded*, parallel control, and positive control to evaluate the efficacy and safety of Botulax® Injection compared to BOTOX® for improving moderate to severe glabellar wrinkles.

Read the detailed description

The case test of 500 qualified test subjects was conducted in 13 institutions nationwide in China. Those who meet all selection criteria and do not meet any of the exclusion criteria are selected as suitable test subjects. The selected test subjects are blinded and divided into the Botulax test group or the BOTOX test group.

02

Conditions studied

  • Glabellar Lines

Keywords

  • botulinum toxin type A
  • Glabellar lines
  • wrinkles
03

In context

Lead sponsor

Hugel is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  1. Aged 18 - 65 years (inclusive), no gender preference
  2. The evaluator at each institution assesses the severity level of glabellar wrinkles at the site in the field when the test subject frowns as much as possible according to the 4-point photographic evaluation table and classifies the subjects with a rating of ≥ 2 (medium or severe).
  3. Persons who can follow the test well, fully understand the clinical trial, rationally foresee the cost-effectiveness of injection, and adhere to the study procedure until the end of the clinical trial are selected.
  4. The test subjects fully understand the test requirements and voluntarily sign the consent form.

Exclusion criteria

Exclusion Criteria:

  1. Subjects who have a history of oversensitivity to the Botulinum Toxin A type, Botulinum Toxin B type, or other control groups of the tested drug substance.
  2. Subjects with clear scars, infections, a carcinogenic or cancerous metastatic lesion on the upper part of the face and/or unrecovered wounds on the face.
  3. Subjects with skin disease, such as dermatitis and acne, or scar on the face, which the investigator judges can affect the evaluation of treatment effectiveness or safety of the test subject.
  4. Subjects who took anticoagulant drugs (e.g., aspirin, nonsteroidal anti-inflammatory drugs, clopidogrel, warfarin, etc.) within two weeks prior to selection; the test subjects who are menstruating can avoid it by delaying the injection of studied products as needed.
  5. Subjects who took drugs with muscle relaxation effects (e.g., muscle relaxants, Curare-like substances, anticholinergic drugs, spectinomycin hydrochloride, aminoglycoside-based drugs, polypeptide antibiotics, tetracycline, lincomycin-based drugs, anticholinergics, benzodiazepines and similar drugs, or benzamide drugs) within 4 weeks prior to selection, anticholinergics, benzodiazepines and similar drugs, or benzamide drugs) or are foreseen to use the above drugs during the study period (for 16 weeks after the injection treatment).
  6. Subjects who have used external medications (e.g., glucocorticoids or tretinoin ointment) on the upper part of the face within 4 weeks prior to the selection or are foreseen to use the drug on the upper part of the face during the study period (for 16 weeks after the injection treatment).
  7. Subjects who have a history of injecting drugs similar to the study drug within 6 months prior to selection or are foreseen to use during the study period (Botulinum Toxin A type or Botulinum Toxin B type).
  8. Subjects who have undergone eye shape correction, laser skin transplantation, skin surgery, IPL, frequency surgery, dermabrasion, chemical dermabrasion, or other laser resolution and nonresolution surgery within 6 months prior to selection or are foreseen to do so during the study period.
  9. Subjects who have had injected hyaluronic acid in the upper part of their face within 12 months prior to selection or plan to do it.
  10. Subjects who have a history of surgery to remove wrinkles on the face above the eyes or a permanent filling injection.
  11. Subjects who plan to undergo a wrinkle removal surgery on their face during the study period, an injection filling of soft tissue for wrinkle removal, or other facial plastic surgeries.
  12. Subjects whom the investigator judges to be unsuitable to participate in this study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
500 participants (actual)

Study arms

  • Experimental
    Test group

    Botulinum Toxin A type for injection (Botulax®)

    Drug: Botulinum Toxin A type for injection (Botulax®)

  • Active comparator
    control group

    Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®)

    Drug: Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®)

Interventions

  • DrugBotulinum Toxin A type for injection (Botulax®)

    Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects

  • DrugBotulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®)

    Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects.

06

What researchers measure

Primary outcomes

  1. Responder rate of improvement in glabellar lines with Physician's rating of line severity

    The rate of test subjects receiving 0 or 1 point by the institution evaluator who assesses the glabellar wrinkles (at maximum frown) at the site in week 4.

    Time frame: Week 4

Secondary outcomes

  1. Responder rate of improvement in glabellar lines with Physician's rating of line severity

    The rate of test subjects receiving 0 or 1 point by the institution evaluator who assesses the glabellar wrinkles (at maximum frown)at the site in weeks 1, 8, 12, and 16 after the treatment

    Time frame: weeks 1, 8, 12, and 16 after the treatment

  2. Responder rate of improvement in glabellar lines at rest with Physician's assessment of severity

    The rate of test subjects receiving 0 or 1 point by the institution evaluator who assesses the glabellar wrinkles (when at rest) at the site in weeks 1, 4, 8, 12, and 16 after the treatment

    Time frame: weeks 1, 4, 8, 12, and 16 after the treatment

  3. Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment

    The rate of test subjects receiving 0 or 1 point by the Independent Evaluation Committee based on the photo of the glabellar wrinkles (at maximum frown) in weeks 1, 4, 8, 12, and 16 after the treatment

    Time frame: weeks 1, 4, 8, 12, and 16 after the treatment

  4. Responder rate of improvement in glabellar lines at rest with investigator's photo assessment

    The rate of test subjects receiving 0 or 1 point by the Independent Evaluation Committee based on the photo of the glabellar wrinkles (when at rest) in weeks 1, 4, 8, 12, and 16 after the treatment

    Time frame: weeks 1, 4, 8, 12, and 16 after the treatment

  5. Responder rate of improvement in glabellar lines with Subject's improvement assessment

    The rate of test subjects who self-assess that the treatment is effective (by giving a score of "+2" or higher) in weeks 1, 4, 8, 12, and 16 after the treatment

    Time frame: weeks 1, 4, 8, 12, and 16 after the treatment

  6. Subject's satisfaction rate

    The rate of test subjects who are satisfied with the treatment effect (test subject's satisfaction rating of 6 - 7) in weeks 1, 4, 8, 12, and 16 after the treatment

    Time frame: weeks 1, 4, 8, 12, and 16 after the treatment

07

Study locations

1 site
  • Hugel Inc.
    Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2017 to primary completion in Jan 2018, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2022
First posted
May 18, 2022
StartActual
May 9, 2017
Primary completionActual
Jan 22, 2018
CompletionActual
Jul 6, 2018
Last update
May 24, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05380154
Lead sponsor
Hugel
Collaborators
Sihuan Pharmaceutical Limited
Responsible party
Sponsor
First posted
May 18, 2022
Start date
May 9, 2017
Primary completion
Jan 22, 2018
Completion
Jul 6, 2018
Last update
May 24, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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