Clinical trial NCT05364580: The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Frown Lines
Keywords: Glabellar Lines
Botulinum toxin
Botulinum toxin type A
Lead sponsor: Protox Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-06
Enrollment: 269
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

  1. Subjects with Neuromuscular Junction Disorder that may affect neuromuscular action
  2. Subjects with previous history of weakness or paralysis in the forehead area
  3. 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

Primary outcomes:
measure: 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
timeFrame: 4 weeks post injection compared to baseline
Secondary outcomes:
measure: Investigator-rated improvement rate of glabellar lines at maximum frown
timeFrame: Week 8, 12, 16
measure: Participant-rated improvement rate of glabellar lines at maximum frown
timeFrame: Week 4, 8, 12, 16
measure: Investigator-rated improvement rate of glabellar lines at rest
timeFrame: Week 4, 8, 12, 16
measure: Participant-rated improvement rate of glabellar lines at rest
timeFrame: Week 4, 8, 12, 16
measure: Independent photo evaluator-rated improvement rate of glabellar lines at frown
timeFrame: Week 4, 8, 12, 16
measure: Independent photo evaluator-rated improvement rate of glabellar lines at rest
timeFrame: Week 4, 8, 12, 16
measure: Participant-rated satisfaction after treatment
timeFrame: Week 4, 8, 12, 16
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
state: Dongdaemun-gu
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
state: Gwangjin-gu
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
state: Gwangjin-gu
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center
state: Nowon-gu
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Seo-gu
Study officials:
affiliation: Chung-Ang University Hospital, Chung-Ang University College of Medicine
name: Kim Beomjoon
role: PRINCIPAL_INVESTIGATOR
affiliation: Konkuk University Medical Center
name: Lee Yangwon
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Hospital
name: Kim Moonbeom
role: PRINCIPAL_INVESTIGATOR
affiliation: Nown Eulji Medical Center, Eulji University
name: Lee Jonghoon
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyunghee University Medical Center
name: Shin Minkyung
role: PRINCIPAL_INVESTIGATOR
References: