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

NCT07622004 | Completed Phase 3

• 1 other identifier: NI101-PLN-CO-002
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glabellar Lines

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline to week 4

Secondary Outcomes (6)

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

  Baseline to week 8, 12, 16

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

  Baseline to week 4, 8, 12, 16

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

  Baseline to week 4, 8, 12, 16

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

  Baseline to week 4, 8, 12, 16

• Improvement rate of glabellar lines as assessed by the subject

  Baseline to week 4, 8, 12, 16

Study Arms (2)

Botulinum toxin type A (INI101)

EXPERIMENTAL

Drug: Botulinum Toxin Type A Injection [INI101]

Botulinum toxin type A (BOTOX®)

ACTIVE COMPARATOR

Drug: Botulinum Toxin Type A Injection [Botox]

Interventions

Botulinum Toxin Type A Injection [INI101] DRUG

Single administration, Day 0, 20 units

Botulinum toxin type A (INI101)

Botulinum Toxin Type A Injection [Botox] DRUG

Single administration, Day 0, 20 units

Botulinum toxin type A (BOTOX®)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• INIBIO Co., Ltd.: lead

Study Sites (1)

INIBIO Co., Ltd.

Seoul, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start: May 27, 2021
• Primary Completion: January 30, 2022
• Study Completion: March 5, 2022
• Last Updated: June 3, 2026

Record last verified: 2026-06

Locations

KR (1)