To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines
NCT ID: NCT01791920
Last Updated: 2022-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
262 participants
INTERVENTIONAL
2011-08-31
2012-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines
NCT03408236
Efficacy and Safety Study of Botulinum Toxin Type A to Treat Glabellar Lines
NCT01237977
Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines
NCT02236312
Evaluate the Safety and Explore the Efficacy of DWP712 With Moderate to Severe Glabellar Lines
NCT06212960
The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines
NCT05364580
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Botulinum toxin type A(Botox®)
Botulinum toxin type A
Botulinum toxin type A(Botulax®)
Single administration, Day 0, 20 units
Botulinum toxin type A (Botulax®)
Botulinum toxin type A
Botulinum toxin type A(Botox®)
Single administration, Day 0, 20units
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Botulinum toxin type A(Botulax®)
Single administration, Day 0, 20 units
Botulinum toxin type A(Botox®)
Single administration, Day 0, 20units
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Subjects who participated in other studies within 30 days or were not passed over 5 times of half life for investigational product
* Subjects who are having trouble with acute disease
* Subjects who have taken any treatment that can affect to glabellar lines and/or any lines around forehead within the previous 6 months
* Subjects who are unable to communicate or follow the instructions
* Subjects who are not eligible for this study based on investigator's judgement
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hugel
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HG-11-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.