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

Medytox

Status and phase: Completed; Phase 2

Conditions: Lateral Canthal Lines

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04143854

MT14-AU18LCL209

Details and patient eligibility

About

This phase 2 study includes two treatment period; 1)Dose- ranging period, Day 0 to 16 weeks, which will assess dose-related safety/tolerance, and the potential to improve the appearance of lateral canthal lines and 2) open-label extension period, 16 weeks to 52 weeks, which will evaluate the long term-safety of MBA-P01

Enrollment: 150 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged 18 to 65
• Bilaterally symmetrical moderate to severe lateral canthal lines(LCLs) at maximum smile 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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150 participants in 3 patient groups, including a placebo group

MBA-P01 24U

Experimental group

Description:

Experimental group; Dose: 24U

Treatment:

Drug: MBA-P01(Botulinum toxin A)

MBA-P01 12U

Experimental group

Description:

Experimental group; Dose: 12U

Treatment:

Drug: MBA-P01(Botulinum toxin A)

Placebo

Placebo Comparator group

Description:

Placebo group; normal saline

Treatment:

Drug: Placebo