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The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.
The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 20U in middle of the forehead. The efficacy and safety are evaluated for 16weeks through 4 follow up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin type A(Meditoxin®) | Experimental |
| |
| Botulinum toxin type A(Botox®) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A(Meditoxin®) | Drug | single administration, Day 0, 20U |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment severity | Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity at baseline and 4 weeks after the injection | 0 and 4 weeks after the injection |
| Measure | Description | Time Frame |
|---|---|---|
| Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment | Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment at baseline, 8, 12 and 16 weeks after the injection | 0, 8, 12 and 16 weeks after the injection |
| Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang-Hun Huh, MD, Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Hoon Kang, MD, Ph.D. | St. Paul Hospital | Principal Investigator |
| Won-Seok Kim, MD, Ph.D. | Kang-Buk Samsung Medical Center | Principal Investigator |
| Jong-Hyun Won, MD, Ph.D. | Seoul Asan Medical Center | Principal Investigator |
| Joo-Hee Lee, MD, Ph.D. | Sevrance Medical Center | Principal Investigator |
| Beom-Joon Kim, MD, Ph.D. | Chung-Ang University Yong-San Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyoung-gi Do | 463-707 | South Korea | ||
| Kangbuk Samsung Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12973229 | Result | Carruthers JD, Lowe NJ, Menter MA, Gibson J, Eadie N; Botox Glabellar Lines II Study Group. Double-blind, placebo-controlled study of the safety and efficacy of botulinum toxin type A for patients with glabellar lines. Plast Reconstr Surg. 2003 Sep 15;112(4):1089-98. doi: 10.1097/01.PRS.0000076504.79727.62. | |
| 19416246 | Result |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C050008 | 3-deoxyglycero-galacto-nonulosonic acid |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Botulinum Toxin Type A(Botox®) | Drug | single administration, Day 0, 20U |
|
Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity at baseline, 4, 8, 12 and 16 weeks after the injection |
| 0, 4, 8, 12 and 16 weeks after the injection |
| Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment | Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment at baseline, 4, 8,12, 16 weeks after the injection | 0, 4, 8,12 and 16 weeks after the injection |
| Glabellar line improvement rate at rest confirmed with investigator's photo assessment of glabellar line severity | Glabellar line improvement rate at rest confirmed with investigator's photo assessment of glabellar line severity at baseline, 4, 8, 12 and 16 weeks after the injection | 0, 4, 8, 12 and 16 weeks after the injection |
| Glabellar line improvement rate confirmed with subject's assessment | Glabellar line improvement rate confirmed with subject's assessment at 4, 8, 12 and 16 weeks after the injection | 4, 8, 12 and 16 weeks after the injection |
| Subject satisfaction rate | Subject satisfaction rate at 4, 8, 12 and 16 weeks after the injection | 4, 8, 12 and 16 weeks after the injection |
| Seoul |
| 110-746 |
| South Korea |
| Sevrance Medical Center | Seoul | 120-749 | South Korea |
| St. Paul Hospital | Seoul | 130-709 | South Korea |
| Seoul Asan Medical Center | Seoul | 138-736 | South Korea |
| Chung-Ang University Yong-San Hospital | Seoul | 140-013 | South Korea |
| Kriegl L, Horst D, Kirchner T, Jung A. LEF-1 expression in basal cell carcinomas. Br J Dermatol. 2009 Jun;160(6):1353-6. doi: 10.1111/j.1365-2133.2009.09144.x. Epub 2009 Mar 30. No abstract available. |
| 9463853 | Result | Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998 Jan 15;17(1):101-10. doi: 10.1002/(sici)1097-0258(19980115)17:13.0.co;2-e. |
| 884196 | Result | Landis JR, Koch GG. An application of hierarchical kappa-type statistics in the assessment of majority agreement among multiple observers. Biometrics. 1977 Jun;33(2):363-74. No abstract available. |
| 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 |