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This study design is a parallel, active drug controlled, double blind, randomized, multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus BOTOX® in treatment of glabella line.
This study design is a parallel, active drug controlled, double blind, randomized, multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus BOTOX® in treatment of glabella line. 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 at 4 weeks, 10 weeks, 16 weeks and the efficacy and safety assessments will be conducted for a total of 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox (Botulinum toxin type A) | Active Comparator | 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. |
|
| MT10107 (Botulinum toxin type A) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox (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 at 4 weeks after the injection. | 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 at 10, 16 weeks after the injection | 10, 16 weeks after the injection |
| Investigator's live assessment of glabella line improvement rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huh Changhun, M.D. | Seoul National University Bundang Hospital | Study Chair |
| Yangwon Lee, M.D. | Konkuk University Hospital | Principal Investigator |
| Jonghee Lee, M.D. | Samsung Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C000710873 | coretox |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| MT10107 (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. |
|
Glabella line improvement rate determined by investigator's live assessment of glabella line severity at rest. |
| 4, 10, 16 weeks after the injection |
| Investigator's photographic assessment of glabella line improvement rate at maximum frown | Glabella line improvement rate determined by investigator's photographic assessment of glabella line severity at maximum frown at 4 weeks after the injection. | 4 weeks after the injection |
| Investigator's photographic assessment of glabella line improvement rate at rest | Glabella line improvement rate determined by investigator's photographic assessment of glabella line severity at rest. | 4 weeks after the injection |
| Subject's satisfaction questionnaire to assess treatment efficacy | Subject's satisfaction questionnaire from score 1 to 7, with 7 being the most satisfied, to assess the glabella line improvement at 4, 10, 16 weeks after the injection. | 4, 10, 16 weeks after the injection |
| Glabella line improvement rate of subject's assessment | Subject's assessment of glabella line improvement rate at 4, 10, 16 weeks after the injection. | 4, 10, 16 weeks after the injection |
| The number of participants with adverse events determined by MedDra ver 17.0 for assessment of safety in IP | The number of participants with adverse events determined by MedDra ver 17.0 for assessment of safety in IP from the study start date to the end of study. | Through study completion, approximately 8 months |
| 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 |