Efficacy and Safety Study of Botulinum Toxin Type A to Treat Glabellar Lines

Medytox

Status and phase

Completed

Phase 3

Conditions

Skin Aging

Treatments

Drug: Botulinum Toxin Type A(Botox®)

Drug: Botulinum Toxin Type A(Meditoxin®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01237977

CSP-MDTX-GL-0901

Details and patient eligibility

About

The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.

Full description

The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 20U in middle of the forehead. The efficacy and safety are evaluated for 16weeks through 4 follow up visits.

Enrollment

314 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men and women aged between 20 and 65
Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
Patients who can comply with the study procedures and visit schedule
Patients who voluntarily sign the informed consent

Exclusion criteria

Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
Patients with severe internal diseases (cardiovascular, respiratory, endocrine diseases etc.)
Patients who have bleeding tendency or taking anti-coagulant
Patients who were injected with botulinum toxin within the past 3 months
Patients with allergy or hypersensitivity to the investigational drugs or their components
Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
Patients with skin disorders or infection at the injection site
Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
Patients with the history of treatment of glabellar part(including forehead) like face lifting and permanent implant or with scars which may affect the treatment results
Patients whose glabellar lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands
Patients who have a plan to receive facial cosmetic procedures including dermal filler, photorejuvenation, chemical peeling and dermabrasion during the study period
Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening or the five times the half life of a drug which was given to patient during the previous clinical trials
Patients who are unable to communicate or follow the instructions
Patients who are not eligible for this study based on the judgment of an investigator