Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Glabellar Lines

Medytox

Status and phase: Completed; Phase 2

Conditions: Glabellar Frown Lines

Treatments: Drug: Placebo; Drug: MBA-P01 (Botulinum toxin A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04143815

MT14-AU18GBL208

Details and patient eligibility

About

This study will determine the effect of MBA-P01 in subjects with glabellar lines at a range of doses compared with placebo.

This study includes two treatment period; 1) Dose-ranging period, Day0 to 16weeks and 2) Open-label extension period, 16 weeks to 52.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female over 18 years of age
• Bilaterally symmetrical moderate to severe GL at maximum frown as assessed by both investigator and subject using FWS

Exclusion criteria

• History of facial nerve paralysis
• Any eyebrow or eyelied ptosis as determined by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups, including a placebo group

MBA-P01 30U

Experimental group

Description:

Experimental group, Dose: 30U

Treatment:

Drug: MBA-P01 (Botulinum toxin A)

MBA-P01 20U

Experimental group

Description:

Experimental group, Dose: 20U

Treatment:

Drug: MBA-P01 (Botulinum toxin A)

MBA-P01 10U

Experimental group

Description:

Experimental group, Dose: 10U

Treatment:

Drug: MBA-P01 (Botulinum toxin A)

Placebo

Placebo Comparator group

Description:

Placebo group, Normal saline

Treatment:

Drug: Placebo