Clinical trial NCT05217355: A Phase II Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glabellar Frown Lines
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2022-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Facial Wrinkle Scale(FWS) change
timeFrame: 4 weeks
Secondary outcomes:
measure: Investigator-rated improvement rate of glabellar lines at maximum frown
timeFrame: Week 8, 12, 16
measure: Investigator-rated improvement rate of glabellar lines at rest
timeFrame: Week 4, 8, 12, 16
measure: Participant-rated improvement rate of glabellar lines at maximum frown
timeFrame: Week 4, 8, 12, 16
measure: Participant-rated improvement rate of glabellar lines at rest
timeFrame: Week 4, 8, 12, 16
measure: Participant-rated satisfaction after treatment
timeFrame: Week 4, 8, 12, 16
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-And Univ. Hospital
state: Dongjak-gu
Study officials:
References: