To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines
Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of "Botulax®" Compared to Botox Inj. in Patients With Moderate to Severe Glabellar Lines
1 other identifier
interventional
262
1 country
6
Brief Summary
To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2011
Shorter than P25 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 13, 2013
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedApril 15, 2022
February 1, 2013
4 months
February 13, 2013
April 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Responder rate of improvement in glabellar lines with Physician's rating of line severity
Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 4weeks post injection.
at 4 weeks post-injection
Secondary Outcomes (7)
Safety evaluation in experimental drug treatment group
4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines with Physician's rating of line severity
8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at rest with investigator's live assessment of severity
4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment
4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at rest with investigator's photo assessment
4, 8, 12, 16 weeks post inejection
- +2 more secondary outcomes
Study Arms (2)
Botulinum toxin type A(Botox®)
ACTIVE COMPARATORBotulinum toxin type A
Botulinum toxin type A (Botulax®)
EXPERIMENTALBotulinum toxin type A
Interventions
Single administration, Day 0, 20 units
Single administration, Day 0, 20units
Eligibility Criteria
You may qualify if:
- Men and women aged between 18 and 65
- Patients attaining grade 2 or 3 in the investigator's rating of glabellar lines severity at maximum frown
- Patients who voluntarily sign the informed consent
- Patients who can comply with the study procedures and visit schedule
You may not qualify if:
- Subjects who had facial plastic surgery (tissue augmentation, brow lift, and dermal resurfacing)treatment within 6 months. Those who had peeling or laser therapy
- Subjects with skin disorders, scar or infection around glabellar region
- Subjects who are taking Aspirin, NSAIDS or anti-coagulant
- Subjects with facial palsy or eyelid ptosis
- Subjects who diagnosed as neuromuscular junction disorder (e.g., myasthenia gravis, Lambert-Eaton Syndrome)
- Subjects with history of drug intoxication, alcohol abuse and/or depressive disorder
- Subjects with severe internal diseases (cardiovascular, respiratory, renal disease, liver disorder)
- Subjects who have previously been treated with botulinum toxin within 3 months (Botulinum toxin type A: 3months, type B: 4 months)
- Subject who have administered following drugs within the previous 4 months: Spectinomycin Hydrochloride, Aminoglycoside antibiotics, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics, muscle relaxants, anti-cholinergic agents, benzodiazepine and similar drugs, benzamide drugs, Tubocurarine-type muscle relaxants
- Subjects who have possibility to take the drugs listed above
- Subjects who have a plan to receive facial cosmetic procedures including dermal filler, chemical peeling and dermabrasion during study period
- Subjects who have glabellar lines that are unable to be improved with any physical method
- Subjects who have history of hypersensitivity to Botulinum toxin and other agents
- Subjects who are pregnant or breast-feeding
- Subjects who have a plan to be pregnant in 3months, or who are not doing contraceptive
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hugellead
Study Sites (6)
Chung-Ang University Hopspital
Seoul, Dongjak-gu, South Korea
Seoul National University Hospital
Seoul, Jongno-Gu, South Korea
National Medical Center
Seoul, Jung-Gu, South Korea
Eulji General Hospital
Seoul, Nowon-Gu, South Korea
The catholic university of Korea, Seoul ST. Mary's Hospital
Seoul, Seocho-Gu, South Korea
Korea University Anam Hospital
Seoul, Seongbuk-Gu, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
February 13, 2013
First Posted
February 15, 2013
Study Start
August 1, 2011
Primary Completion
December 1, 2011
Study Completion
March 1, 2012
Last Updated
April 15, 2022
Record last verified: 2013-02