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Completed

NCT Number: NCT07622004

Evaluate the Efficacy and Safety of INI101 Compared to BOTOX® in Subjects With Moderate to Severe Glabellar Lines.

To evaluate the efficacy and safety of botulinum toxin type A for injection INI101 compared to BOTOX® in subjects with moderate to severe glabellar lines.

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Key information

Conditions

Glabellar Lines

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

INIBIO Co., Ltd.

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult male or female participants aged between 19 and 65 years old.
  • Participants whose glabellar line score was 2 (moderate) or higher of glabellar line score at maximum frown based on the investigator's judgment at screening and randomization.
  • Participants who voluntarily gave a consent in writing to participate in the clinical study with full knowledge of details of the study after listening to them.
  • Participants who can understand and comply with the procedures and visit schedules of the study.

Exclusion criteria

  • Systemic neuromuscular junction disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, hereditary motor neuropathy, etc.)
  • History of blepharoplegia or ptosis
  • Prominent facial asymmetry
  • Glabellar lines that are physically difficult to be improved, such as the case where the lines are not removed by hands
  • Participants who have received any drugs that can act as a systemic muscle relaxant within 4 weeks prior to screening
  • Participants who have received anticoagulants, anti-platelet agents, or systemic NSAIDs within 7 days prior to administration of investigational products (however, low-dose aspirin [325 mg/day or less] administered for antithrombotic purposes is acceptable)
  • Participants who have participated in other clinical trials of a drug/medical device within 30 days from participating in this clinical study and have been administered/treated with the investigational product/medical device
  • Participants deemed ineligible for this study for other reasons based on the investigator's judgment

Treatment and study plan

Botulinum Toxin Type A Injection [INI101]

Drug

Single administration, Day 0, 20 units

Botulinum Toxin Type A Injection [Botox]

Drug

Single administration, Day 0, 20 units

Primary outcomes

  1. Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment

    Time frame: Baseline to week 4

    Investigator assessed the subject's glabellar lines 'At maximum frown' on a 4-point facial wrinkle scale (FWS) after 4 weeks of the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.

Secondary outcomes

  1. Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment

    Time frame: Baseline to week 8, 12, 16

    Investigator assessed the subject's glabellar lines 'At maximum frown' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.

  2. Improvement rate of glabellar lines at rest according to the investigator's on-site assessment

    Time frame: Baseline to week 4, 8, 12, 16

    Investigator performed on-site assessment of the subject's glabellar lines 'At rest' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.

  3. Improvement rate of glabellar lines at maximum frown according to the independent assessor's photo assessment

    Time frame: Baseline to week 4, 8, 12, 16

    Independent assessor assessed the subject's glabellar lines 'At maximum frown' ' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation. An independent assessor separately conducted the FWS assessment subsequently based on the photographs taken.

  4. Improvement rate of glabellar lines at rest according to the independent assessor's photo assessment

    Time frame: Baseline to week 4, 8, 12, 16

    Independent assessor assessed the subject's glabellar lines 'At rest' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation. An independent assessor separately conducted the FWS assessment subsequently based on the photographs taken.

  5. Improvement rate of glabellar lines as assessed by the subject

    Time frame: Baseline to week 4, 8, 12, 16

    Subjects assessed their glabellar lines at each time point after the administration of the investigational product compared to baseline.

  6. Subject's satisfaction

    Time frame: Baseline to week 4, 8, 12, 16

    Subject's satisfaction score for the improvement of glabellar lines was investigated at each time point after the administration of the investigational product compared to before administration.

Sponsors and collaborators

Lead sponsor

INIBIO Co., Ltd.

Industry

Registry information

Official study title

A Multi-center, Double-blind, Randomized, Parallel, Active-controlled Phase III Trial to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection INI101 Compared to BOTOX® in Subjects With Moderate to Severe Glabellar Lines.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 2, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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