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This study design is multi-center, randomized, double-blind, parallel group, active controlled, phase 3 clinical trial(Including randomized, double-blind, parallel group, active controlled, preliminary study). Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the comparator at a total of 20U(4U/0.1ml each)in five sites of the glabella line. Thereafter, follow-up visits will be made 4 weeks, 10weeks, 16weeks and efficacy and safety assessments will be conducted for total 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT10109L(Botulinum toxin type A) | Experimental |
| |
| BOTOX® 50U(Botulinum toxin type A) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Drug | 20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's live assessment of glabella line improvement rate | Glabella line improvement rate determined by investigator's live assessment of glabella line severity at maximum frown | 4 weeks after the injection |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's live assessment of glabella line improvement rate | Glabella line improvement rate determined by investigator's live assessment of glabella line severity at maximum frown | 16 weeks after the injection |
| Investigator's live assessment of glabella line improvement rate |
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Inclusion Criteria:
Main inclusion criteria
1. Patients attaining ≥grade 2(moderate) in the investigator's rating of the severity of glabella line at maximum frown
Other inclusion criteria
Exclusion Criteria:
Patients with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis)
Patients who have bleeding tendency or taking anti-coagulant
Patients suffering from acute diseases
Patients who have been injected with botulinum toxin within past 3 months before the injection
Patients with allergy or hypersensitivity to the investigational products or their components
Patients who are pregnant or lactating or found pregnancy through the urine or serum test or disagreed to avoid pregnancy during 16 weeks study period
* All childbearing female subjects, excepting who had amenorrhea over 12 months or sterilization operation(bilateral tubal ligation, bilateral oophorrectomy or hysterectomy), shouldn't be enrolled the study until they tested negative on pregnancy test(urine or serum). The contraceptions which are medically allowable are spermicides, oral contraceptives, barrier method, intrauterine contrace, complete sexual abstinence
Patients who have been given any of the following drugs within previous 4 weeks at screening
Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
Patients with skin damage or infection at the injection site.
Patients who have received or have a plan to receive other procedures which may affect glabella and forehead lines within 6 months
* These treatments include soft tissue augmentation in the range of glabella (e.g. hyaluronic acid or collagen-type implants), medium depth peels, facial lifting, dermal photorejuvenation et cetera.
Patients whose glabella lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands
Patients who are participating in other clinical trials or have participated in other clinical trials within 30days of the screening date.
Patients who are unable to communicate or follow the instructions
Patients who are not eligible for this study at the discretion of the investigator
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| Name | Affiliation | Role |
|---|---|---|
| Hoon Kang, M.D. | Catholic University of Korea Saint Paul's Hospital | Principal Investigator |
| Gwang Seong Choi, M.D., Ph.D. | Inha University Hospital | Principal Investigator |
| Woo Young Sim, M.D. | Kyung Hee University Hospital at Gangdong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, St. Paul's Hospital | Seoul | Dongdaemun-gu | South Korea | |||
| Inha University Hospital |
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Glabella line improvement rate determined by investigator's live assessment of glabella line severity at rest. |
| 4, 16 weeks after the injection |
| Investigator's photographic assessment of glabella line improvement rate | Glabella line improvement rate determined by investigator's photographic assessment of glabella line severity at maximum frown | 4 weeks after the injection |
| Investigator's photographic assessment of glabella line improvement rate | Glabella line improvement rate determined by investigator's photographic assessment of glabella line severity at rest. | 4 weeks after the injection |
| Subject's assessment of glabella line improvement rate | Glabella line improvement rate determined by subject's assessment of glabella line severity. | 4, 10, 16 weeks after the injection |
| Subject's satisfaction questionnaire | Subject's satisfaction of glabella line improvement at 4, 10, 16 weeks after the injection. | 4, 10, 16 weeks after the injection |
| Number of adverse events in subjects | Number of adverse events occuring in all subject for the entire study period. | Up to 16 weeks |
| Incheon |
| Jung-gu |
| South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | Kangdong-gu | South Korea |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| 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 |
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