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

Medytox

Status and phase

Completed

Phase 2

Conditions

Glabellar Frown Lines

Treatments

Drug: MBA-P01 (Botulinum toxin A)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05217355

MT14-KR21GBL201

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

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