The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines

NCT05364580 | Completed Phase 3

• 1 other identifier: PT_BTA_P3_21
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 5

Brief Summary

This study will be conducted in Phase Ⅲ clinical trials. In Phase Ⅲ, subjects with moderate to severe glabellar lines are enrolled and those who are judged to be eligible for this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL each) in five sites of the glabellar lines. The investigational product is administered once, maintaining double-blind for a total of 16 weeks of observation. Thereafter, efficacy and safety are assessed by comparing with BOTOX® after regular visits conducted at 4,8,12 and 16 weeks.

Conditions

Glabellar Frown Lines

Keywords

Glabellar Lines; Botulinum toxin; Botulinum toxin type A

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving at least a 2-grade improvement from baseline on the facial wrinkle scale of GL at maximum frown at Week 4

  The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe

  4 weeks post injection compared to baseline

Secondary Outcomes (7)

• Investigator-rated improvement rate of glabellar lines at maximum frown

  Week 8, 12, 16

• Participant-rated improvement rate of glabellar lines at maximum frown

  Week 4, 8, 12, 16

• Investigator-rated improvement rate of glabellar lines at rest

  Week 4, 8, 12, 16

• Participant-rated improvement rate of glabellar lines at rest

  Week 4, 8, 12, 16

• Independent photo evaluator-rated improvement rate of glabellar lines at frown

  Week 4, 8, 12, 16

Study Arms (2)

PROTOXIN(Phase Ⅲ)

EXPERIMENTAL

PROTOXIN will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL)

Biological: PROTOXIN

Botox® (Phase Ⅲ)

ACTIVE COMPARATOR

Botox® will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL).

Biological: Botox®

Interventions

PROTOXIN BIOLOGICAL

Botulinum toxin Type A

PROTOXIN(Phase Ⅲ)

Botox® BIOLOGICAL

Botulinum toxin Type A

Botox® (Phase Ⅲ)

Eligibility Criteria

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

You may qualify if:

• Men and women aged between 19 to 65 years old
• Subjects attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
• Those who understand and comply with clinical trial procedures and visit schedules
• Subjects who voluntarily decides to participate and signs the consent form after hearing the explanation of this clinical trial.

You may not qualify if:

• Those with or accompanied by the following diseases at the time of screening
• Subjects with Neuromuscular Junction Disorder that may affect neuromuscular action
• Subjects with previous history of weakness or paralysis in the forehead area
• Subjects with infection, skin disorders, or scars at the glabellar region
• Subjects with wrinkles that physically prevent wrinkles from spreading, such as when wrinkles are not spread out by hand
• Subjects who is administering a drug with muscle relaxation within four weeks of screening.
• Subjects who have taken Aspirin and NSAIDs within 7 days prior to administration of the investigational drug
• Subjects with surgical history who may affect wrinkles around the forehead or glabellar region
• Subjects who have planned facial cosmetic procedure during the clinical trial
• Subjects who have been administered similar drugs within 12 weeks (Botulinum toxin type A) or within 16 weeks (Botulinum toxin type B) before screening
• Subjects who are expected to administer botulinum toxin preparations other than Investigational product during the clinical trial period
• Subjects with allergy or hypersensitivity to the botulinum toxin or their components
• A history of drug or alcohol abuse
• Anxiety disorders or other significant mental disorders based on the judgment of an investigator
• Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception

Sponsors & Collaborators

• Protox Inc.: lead

Study Sites (5)

Kyung Hee University Hospital

Seoul, Dongdaemun-gu, South Korea

Location

Chung-Ang University Hospital

Seoul, Gwangjin-gu, South Korea

Location

Konkuk University Hospital

Seoul, Gwangjin-gu, South Korea

Location

Nowon Eulji Medical Center

Seoul, Nowon-gu, South Korea

Location

Pusan National University Hospital

Pusan, Seo-gu, South Korea

Location

Related Publications (1)

• Son HS, Shin MK, Lee JH, Kim MB, Yoo KH, Choi SY, Han HS, Seok J, Kim BJ, Lee YW. Efficacy and Safety of Novel Botulinum Toxin Type A (Protoxin) in the Treatment of Moderate to Severe Glabellar Lines: A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Study. Ann Dermatol. 2026 Feb;38(1):33-41. doi: 10.5021/ad.25.124.

  PMID: 41607140 DERIVED

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 Officials

• Kim Beomjoon

  Chung-Ang University Hospital, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

• Lee Yangwon

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

• Kim Moonbeom

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

• Lee Jonghoon

  Nown Eulji Medical Center, Eulji University

  PRINCIPAL INVESTIGATOR

• Shin Minkyung

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

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: April 19, 2022
• First Posted: May 6, 2022
• Study Start: March 6, 2023
• Primary Completion: June 20, 2023
• Study Completion: October 6, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)