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

Medytox

Status and phase: Completed; Phase 2

Conditions: Glabellar Frown Lines

Treatments: Biological: MT10109

Study type: Interventional

Funder types: Industry

Identifiers

NCT01485601

MT-GPRT-GL01

Details and patient eligibility

About

The purpose of this study is to find an optimal dose to determine the safety and tolerability of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular injection in subjects with glabellar lines compared with the standard dose of BOTOX®

Enrollment: 121 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged between 18 and 75 years with glabellar facial lines of at least moderate severity at maximum frown by investigator's assessment.
• Women of childbearing potential must have a negative serum pregnancy test at screening

Exclusion criteria

• Patients with an inability to substantially lessen glabellar lines by physically spreading them apart.
• Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
• Patients with an anaphylactic response history to botulinum toxin type A.
• Patients who have been administered botulinum toxin type A within the previous 6 months.
• Pregnant or lactating women.
• Participation in any research study involving drug administration within 90 days preceding enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 2 patient groups

MT10109

Experimental group

Description:

Clostridium botulinum toxin type A

Treatment:

Biological: MT10109

Botox (registered trade mark)

Active Comparator group

Description:

Clostridium botulinum toxin type A

Treatment:

Biological: MT10109