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

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.

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.

Study Overview

• Status: Completed
• Conditions: Glabellar Lines
• Intervention / Treatment: Drug: Botulinum Toxin Type A Injection [Botox]; Drug: Botulinum Toxin Type A Injection [INI101]

• Study Type: Interventional
• Enrollment (Actual): 292
• Phase: Phase 3

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, South Korea
      • INIBIO Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Adult male or female participants aged between 19 and 65 years old.
2. 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.
3. 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.
4. Participants who can understand and comply with the procedures and visit schedules of the study.

Exclusion Criteria:

1. Systemic neuromuscular junction disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, hereditary motor neuropathy, etc.)
2. History of blepharoplegia or ptosis
3. Prominent facial asymmetry
4. Glabellar lines that are physically difficult to be improved, such as the case where the lines are not removed by hands
5. Participants who have received any drugs that can act as a systemic muscle relaxant within 4 weeks prior to screening
6. 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)
7. 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
8. Participants deemed ineligible for this study for other reasons based on the investigator's judgment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botulinum toxin type A (INI101)	Drug: Botulinum Toxin Type A Injection [INI101]; Single administration, Day 0, 20 units
Active Comparator: Botulinum toxin type A (BOTOX®)	Drug: Botulinum Toxin Type A Injection [Botox]; Single administration, Day 0, 20 units

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment	'Improvement' is defined as a case where the glabellar line score is improved by 2 points or more from baseline	Baseline to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment	'Improvement' is defined as a case where the glabellar line score is improved by 2 points or more from baseline	Baseline to week 8, 12, 16
Improvement rate of glabellar lines at rest according to the investigator's on-site assessment	'Improvement' is defined as a case where the glabellar line score is improved by 2 points or more from baseline	Baseline to week 4, 8, 12, 16
Improvement rate of glabellar lines at maximum frown according to the independent assessor's photo assessment	'Improvement' is defined as a case where the glabellar line score is improved by 2 points or more from baseline	Baseline to week 4, 8, 12, 16
Improvement rate of glabellar lines at rest according to the independent assessor's photo assessment	'Improvement' is defined as a case where the glabellar line score is improved by 2 points or more from baseline	Baseline to week 4, 8, 12, 16
Improvement rate of glabellar lines as assessed by the subject	'Improvement' is defined as a case where the glabellar line score is +2, or +3, or +4.	Baseline to week 4, 8, 12, 16
Participant-rated satisfaction after treatment	'Satisfied' is defined as a satisfaction assessment score of 6 or 7 on the improvement of the glabellar line.	Baseline to week 4, 8, 12, 16

Collaborators and Investigators

• Sponsor: INIBIO Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): March 5, 2022

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Botulinum Toxins, Type A
• Other Study ID Numbers: NI101-PLN-CO-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No