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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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