Skip to main content
OpenTrials
Completed

NCT Number: NCT05217355

A Phase II Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines

This study is intended to evaluate the efficacy and safety of MBA-P01 compared to placebo in treatment of glabellar lines.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chung-And Univ. Hospital

Seoul, Dongjak-gu, 156-755, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women aged between 19 and 65
  • Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
  • Patients who voluntarily sign the informed consent

Exclusion criteria

  • Patients with the history of facial nerve paralysis
  • Patients with the symptoms of eyelid ptosis determined by the investigator
  • Marked facial asymmetry, dermatochalasis, deep dermal scarring in the glabellar area, excessively thick sebaceous skin, or the inability to substantially lessen glabellar lines even by physically spreading them apart, as determined by the investigator
  • Active skin disease or infection in the treatment area
  • History of surgery which may habe altered the anatomy of the corrugator supercilia muscle or the procerus muscle or related nerve
  • Prior treatment with permanent filers, synthetic implantation, and/or autologous fat transplantation in the treatment area
  • Subject who received the following drugs within 4 weeks prior to the screening
  • muscle relaxant: Peripherally acting relaxants, Centrally acting muscle relaxants, skeletal muscle relaxants
  • benzodiazepine: Diazepam, Chlodiazepoxide, Medazepam, Oxazepam, Potassium clorazepate, Lorazepam etc.
  • Subject who takes Muscle relaxants and benzodiazepine stably for 4 weeks can participate the study
  • Subject who reveived any of the below facial aesthetic treatments that, in the investigator's opinion, could interfere the evaluation of efficacy
  • Prior treatment with fillers in the treatment area within 1 year prior to screening (CaHA, Hyaluronic acid, PLLA, PCL etc.)
  • Facial resurfacing or skin tightening procedure with lase, light or radiofrequency-based system; or any medium depth or deep depth facial chemical peels in the upper face within 6 months prior to screening
  • Subject who received Retinois following period
  • Systemic drug delivery : within 6 months prior to the screening
  • Local drug delivery : within 3 months prior to the screening
  • Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
  • Known immunization or hypersensitivity to any botulinum toxin preparations
  • Subject who had botulinum toxin treatment within 6 months prior to the screening or planning to receive botulinum toxic treatment during the study period other than study treatment
  • Female subjects who are pregnant or nursing, or planning a pregnancy during the study and female subjects of childbearing potential who are not willing to use acceptable form of sontraception
  • Subject who are participating in other interventional clinical study or have participated in such a study within 30 dyas prior to screening
  • Subjects who are not eligible for this study at the discretion of the investigator

Treatment and study plan

MBA-P01 (Botulinum toxin A)

Drug

MBA-P01 will be injected into the Glabellar line

Placebo

Drug

Placebo will be injected into the Glabellar line

Primary outcomes

  1. Facial Wrinkle Scale(FWS) change

    Time frame: 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

Secondary outcomes

  1. Investigator-rated improvement rate of glabellar lines at maximum frown

    Time frame: Week 8, 12, 16

    The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

  2. Investigator-rated improvement rate of glabellar lines at rest

    Time frame: Week 4, 8, 12, 16

    The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

  3. Participant-rated improvement rate of glabellar lines at maximum frown

    Time frame: Week 4, 8, 12, 16

    The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

  4. Participant-rated improvement rate of glabellar lines at rest

    Time frame: Week 4, 8, 12, 16

    The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

  5. Participant-rated satisfaction after treatment

    Time frame: Week 4, 8, 12, 16

    Proportion of subject achieving at least 5 score in Participant-rated satisfaction

Sponsors and collaborators

Lead sponsor

Medytox Korea

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2022
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.