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Completed

NCT Number: NCT05364580

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

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.

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Key information

Conditions

Glabellar Frown Lines

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kyung Hee University Hospital, Seoul, Dongdaemun-gu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Pregnant or lactating women
  • Subjects with severe comorbidities or acute diseases that does not suitable for participation in clinical trials
  • Those who participated in other clinical trials/clinical medical device trials within 30 days prior to screening and who received Investigational product/medical devices/procedures, or those who had less than 5 times the half-life of the Investigational product
  • Subjects who are not eligible for this study based on the judgment of an investigator

Treatment and study plan

PROTOXIN

Biological

Botulinum toxin Type A

BOTOX®

Biological

Botulinum toxin Type A

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

    Time frame: 4 weeks post injection compared to baseline

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

Secondary outcomes

  1. Investigator-rated improvement rate of glabellar lines at maximum frown

    Time frame: Week 8, 12, 16

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

  2. Participant-rated improvement rate of glabellar lines at maximum frown

    Time frame: Week 4, 8, 12, 16

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

  3. Investigator-rated improvement rate of glabellar lines at rest

    Time frame: Week 4, 8, 12, 16

    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. Participant-rated improvement rate of glabellar lines at rest

    Time frame: Week 4, 8, 12, 16

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

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

    Time frame: Week 4, 8, 12, 16

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

  6. Independent photo evaluator-rated improvement rate of glabellar lines at rest

    Time frame: Week 4, 8, 12, 16

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

  7. Participant-rated satisfaction after treatment

    Time frame: Week 4, 8, 12, 16

    Participant evaluate the level of satisfaction by Patient Satisfaction(PS) 7-grade score(1 to 7) where 1 = very dissatisfied and 7 = very satisfied

Sponsors and collaborators

Lead sponsor

Protox Inc.

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Compare the Efficacy and Safety of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 6, 2022
Registry last updated
Nov 18, 2023

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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