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

NCT05217355 | Completed Phase 2

• 1 other identifier: MT14-KR21GBL201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Investigator-rated improvement rate of glabellar lines at maximum frown

  Week 8, 12, 16

• Investigator-rated improvement rate of glabellar lines at rest

  Week 4, 8, 12, 16

• Participant-rated improvement rate of glabellar lines at maximum frown

  Week 4, 8, 12, 16

• Participant-rated improvement rate of glabellar lines at rest

  Week 4, 8, 12, 16

• Participant-rated satisfaction after treatment

  Week 4, 8, 12, 16

Study Arms (2)

MBA-P01

EXPERIMENTAL

Experimental group, Dose: 20U

Drug: MBA-P01 (Botulinum toxin A)

Placebo

PLACEBO COMPARATOR

Placebo gorup, Normal saline

Drug: Placebo

Interventions

MBA-P01 (Botulinum toxin A) DRUG

MBA-P01 will be injected into the Glabellar line

MBA-P01

Placebo DRUG

Placebo will be injected into the Glabellar line

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medytox Korea: lead

Study Sites (1)

Chung-And Univ. Hospital

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

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: February 1, 2022
• Study Start: December 28, 2021
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

KR (1)