Status:
COMPLETED
To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines
Lead Sponsor:
Hugel
Conditions:
Skin Aging
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT01791920
Start Date
August 1 2011
End Date
March 1 2012
Last Update
April 15 2022
Active Locations (6)
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1
Chung-Ang University Hopspital
Seoul, Dongjak-gu, South Korea
2
Seoul National University Hospital
Seoul, Jongno-Gu, South Korea
3
National Medical Center
Seoul, Jung-Gu, South Korea
4
Eulji General Hospital
Seoul, Nowon-Gu, South Korea