Clinical trial NCT01791920: To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Aging
Lead sponsor: Hugel
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Responder rate of improvement in glabellar lines with Physician's rating of line severity
timeFrame: at 4 weeks post-injection
Secondary outcomes:
measure: Safety evaluation in experimental drug treatment group
timeFrame: 4, 8, 12, 16 weeks post-injection
measure: Responder rate of improvement in glabellar lines with Physician's rating of line severity
timeFrame: 8, 12, 16 weeks post-injection
measure: Responder rate of improvement in glabellar lines at rest with investigator's live assessment of severity
timeFrame: 4, 8, 12, 16 weeks post-injection
measure: Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment
timeFrame: 4, 8, 12, 16 weeks post-injection
measure: Responder rate of improvement in glabellar lines at rest with investigator's photo assessment
timeFrame: 4, 8, 12, 16 weeks post inejection
measure: Responder rate of improvement in glabellar lines with Subject's improvement assessment
timeFrame: 4, 8, 12, 16 weeks post-injections
measure: Subject's satisfaction rate
timeFrame: 4, 8, 12, 16 weeks post-injection
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hopspital
state: Dongjak-gu
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-Gu
city: Seoul
country: Korea, Republic of
facility: National Medical Center
state: Jung-Gu
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
state: Nowon-Gu
city: Seoul
country: Korea, Republic of
facility: The catholic university of Korea, Seoul ST. Mary's Hospital
state: Seocho-Gu
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seongbuk-Gu
Study officials:
References: