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| ID | Type | Description | Link |
|---|---|---|---|
| 396936 | Other Identifier | CEP00/11 | |
| CEP001/11 | Other Identifier | Research Ethics Committee, Brazil |
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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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This study evaluates the diffusion area (cephalic, lateral, medial and caudal points) of the botulinum toxin type A in the frontal muscle for usual concentrations and dilutions of the drug. A basal line control and After the application control will be made, and the investigators will evaluate the drug effects, based on clinical aspects, photographic registers and through electromyography exam (EMG).
Considering the results of our investigation, the investigators may propose a pattern of application of BOTULINUM TOXIN TYPE-A Botox® in the frontal area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin Type-A 1U | Other |
| |
| Botulinum Toxin Type-A 2U | Other |
| |
| Botulinum Toxin Type-A 3U | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type-A (day 0) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Area | Radial area (cephalic, lateral, medial and caudal points) of physioelectric activity of the frontal muscle, measured with electromyography (EMG). Clinical and Photographical register evaluation of the dynamical wrinkles in the treatment area. | Change from baseline at day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Treatment Phase | Quantity of Botulinum Toxin used in every subject to aim to complete the treatment to the rest of the frontal area, based on the results of the primary outcomes. | Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ivo Pitanguy Institute | Rio de Janeiro | Rio de Janeiro | 22280-020 | Brazil |
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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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| Botulinum Toxin Type-A (day 0) | Drug |
|
|
| Botulinum Toxin Type-A (day 0) | Drug | Botulinum Toxin Type-A 3 units. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
|
|
| 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 |