Clinical trial NCT04996810: The Safety and Efficacy Study of PROTOXIN in Subjects With Moderate to Severe Glabellar Lines
Official title: A Randomized, Double-blinded, Active Comparator, Single-dose, Phase I/II Trial to Evaluate the Safety and Efficacy of Treatment With PROTOXIN as Compared to BOTOX® in Adult Subjects Who Need Improvement of Moderate or Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glabellar Frown Lines
Keywords: Glabellar Lines
Botulinum toxin
Botulinum toxin type A
Lead sponsor: Protox Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-09
Enrollment: 60
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 I/II clinical trials. In Phase I, 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. Safety is assessed after 12 weeks. In Phase II, subjects with moderate to severe glabellar lines are enrolled and will be injected the "PROTOXIN" or the "BOTOX®" at a total of 20U(4U/0.1mL each)in five sites of the glabellar lines. Thereafter, efficacy and safety are assessed by comparing with BOTOX®.


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 glabellar lines at maximum frown
* Fertile women who have properly agreed to contraception during the clinical trial period
* Subjects who voluntarily sign the informed consent

Exclusion Criteria:

* Subjects who answered 'Yes' any of the C-SSRS questions (only Phase I)
* Subjects with the general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome)
* Subjects who suffer from muscle weakness or paralysis in the forehead area
* Subjects with infection, skin disorders, or scars at the glabellar region.
* Subjects with noticeable facial asymmetry
* Subjects with allergy or hypersensitivity to the botulinum toxin or their components
* Subjects who have taken Anti-Coagulant, Anti-Platelet agent, Aspirin and NSAIDs within 7 days prior to administration of the investigational drug
* Subjects who were injected facial with botulinum toxin within the past 6 months or whose dose exceeds 200 U for the whole body
* Subjects with previous treatment of Face Lifting, Permanent Implant, and/or Filler in the glabellar region
* Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks of the screening date.
* A history of drug or alcohol abuse
* Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception
* Subjects who are not eligible for this study based on the judgment of an investigator

Primary outcomes:
measure: Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)
timeFrame: 12 weeks after the injection
measure: Glabellar line improvement rate confirmed with investigator's assessment (Phase II)
timeFrame: 4 weeks after the injection
Secondary outcomes:
measure: Glabellar line improvement rate confirmed with investigator's assessment (Phase II)
timeFrame: 4, 8, 12 weeks after the injection
measure: Glabellar line improvement rate confirmed by subject' satisfaction assessment (Phase II)
timeFrame: 4, 8, 12 weeks after the injection
measure: Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II)
timeFrame: 12 weeks after the injection
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Beomjoon Kim
role: PRINCIPAL_INVESTIGATOR
References: