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This study is intended to evaluate the efficacy and safety of MBA-P01 compared to placebo in treatment of glabellar lines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBA-P01 | Experimental | Experimental group, Dose: 20U |
|
| Placebo | Placebo Comparator | Placebo gorup, Normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBA-P01 (Botulinum toxin A) | Drug | MBA-P01 will be injected into the Glabellar line |
| |
| 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 |
| 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 |
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Inclusion Criteria:
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 reveived any of the below facial aesthetic treatments that, in the investigator's opinion, could interfere the evaluation of efficacy
Subject who received Retinois following period
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-And Univ. Hospital | Seoul | Dongjak-gu | 156-755 | South Korea |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Placebo |
| Drug |
Placebo will be injected into the Glabellar line |
|
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 |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |