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

Hugel6 sites in 1 country262 target enrollmentAugust 2011

Overview

Phase: Phase 3
Intervention: Botulinum toxin type A(Botulax®)
Conditions: Skin Aging
Sponsor: Hugel
Enrollment: 262
Locations: 6
Primary Endpoint: Responder rate of improvement in glabellar lines with Physician's rating of line severity
Status: Completed
Last Updated: 4 years ago

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

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

March 2012

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Hugel

Responsible Party

Sponsor

•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

•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

Botulinum toxin type A

Intervention: Botulinum toxin type A(Botulax®)

Botulinum toxin type A

Intervention: Botulinum toxin type A(Botox®)

Responder rate of improvement in glabellar lines with Physician's rating of line severity

Time Frame: at 4 weeks post-injection

Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 4weeks post injection.

Safety evaluation in experimental drug treatment group(4, 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 with Subject's improvement assessment(4, 8, 12, 16 weeks post-injections)
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 photo assessment(4, 8, 12, 16 weeks post inejection)
Subject's satisfaction rate(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)