To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines

Hugel

Status and phase

Completed

Phase 3

Conditions

Skin Aging

Treatments

Drug: Botulinum toxin type A(Botox®)

Drug: Botulinum toxin type A(Botulax®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01791920

HG-11-01

Details and patient eligibility

About

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

Enrollment

262 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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