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

Phase 2

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Drug: MBA-P01 (Botulinum toxin A); Drug: Placebo

• Registration Number: NCT04143815
• Lead Sponsor: Medy-Tox

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-20
• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-29
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBA-P01 20U	MBA-P01 (Botulinum toxin A)	Experimental group, Dose: 20U
Placebo	Placebo	Placebo group, Normal saline
MBA-P01 30U	MBA-P01 (Botulinum toxin A)	Experimental group, Dose: 30U
MBA-P01 10U	MBA-P01 (Botulinum toxin A)	Experimental group, Dose: 10U

Primary Outcome Measures

Name	Time	Method
Facial Wrinkle Scale(FWS) change	4 weeks	Proportion of subjects achieving at least a 2-grade decrease from baseline in score of Facial Wrinkle Scale (FWS) (0:none to 3: severe) of Glabellar line at maximum frown

Trial Locations

Locations (1)

Maroubra MEdical Centre; 🇦🇺 Maroubra, New South Wales, Australia