Long-term Extension Study to Evaluate MBA-P01 in Subjects With Moderate to Severe Glabellar Lines

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Medytox

Status and phase

Completed
Phase 3

Conditions

Glabellar Frown Lines

Treatments

Drug: MBA-P01

Study type

Interventional

Funder types

Industry

Identifiers

NCT05321979
MT14-KR21GBL1202

Details and patient eligibility

About

This study is intended to evaluate long-term safety and efficacy of MBA-P01 in treatment of glabellar lines.

Enrollment

253 patients

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who completed the phase III trial (MT14-KR20GBL309)
  • Patients who were capable of understanding and complying with the protocol and have signed the informed consent form voluntarily

Exclusion criteria

  • Patients who have received other procedures which may affect glabellar lines within 6 months (except of MBA-P01 or BOTOX® treated in phase III trial, MT14-KR20GBL309)
  • Female patients who are pregnant or lactating. Female patients of childbearing age who have a plan to get pregnant during the study period.
  • Patient who do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
  • Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
  • Patients who are not eligible for this study based on the judgment of an investigator

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

253 participants in 1 patient group

MBA-P01
Experimental group
Description:
MBA-P01 will be injected into GL:
Treatment:
Drug: MBA-P01

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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