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

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

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

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Drug: MBA-P01 (Botulinum toxin A); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dongjak-gu
    • Seoul, Dongjak-gu, Korea, Republic of, 156-755
      • Chung-And Univ. Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

  1. muscle relaxant: Peripherally acting relaxants, Centrally acting muscle relaxants, skeletal muscle relaxants

  2. 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

  1. Prior treatment with fillers in the treatment area within 1 year prior to screening (CaHA, Hyaluronic acid, PLLA, PCL etc.)
  2. 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

  1. Systemic drug delivery : within 6 months prior to the screening
  2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBA-P01; Experimental group, Dose: 20U	Drug: MBA-P01 (Botulinum toxin A); MBA-P01 will be injected into the Glabellar line
Placebo Comparator: Placebo; Placebo gorup, Normal saline	Drug: Placebo; Placebo will be injected into the Glabellar line

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial Wrinkle Scale(FWS) change	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	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator-rated improvement rate of glabellar lines at maximum frown	The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.	Week 8, 12, 16
Investigator-rated improvement rate of glabellar lines at rest	The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.	Week 4, 8, 12, 16
Participant-rated improvement rate of glabellar lines at maximum frown	The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.	Week 4, 8, 12, 16
Participant-rated improvement rate of glabellar lines at rest	The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.	Week 4, 8, 12, 16
Participant-rated satisfaction after treatment	Proportion of subject achieving at least 5 score in Participant-rated satisfaction	Week 4, 8, 12, 16

Collaborators and Investigators

• Sponsor: Medytox Korea

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2021
• Primary Completion (Actual): June 22, 2022
• Study Completion (Actual): June 22, 2022

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: MT14-KR21GBL201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No