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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005901-29 | EudraCT Number |
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The purpose of this study is to evaluate the distribution of IncobotulinumtoxinA (Xeomin) in healthy subjects at different volumes, concentrations and doses when administered intradermally and subcutaneously using different delivery methods (conventional needle and microneedles).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LMRC (left with micro-/right with conv- needle) | Experimental |
| |
| RMLC (right with micro-/left with conv- needle) | Experimental |
| |
| LCRM (left with conv-/ right with micro-needles) | Experimental |
| |
| RCLM (right with conv-/left with micro-needles) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IncobotulinumtoxinA | Drug | Intradermal injections using different delivery methods (conventional needle and microneedles) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area of anhidrosis on contralateral points of the forehead four weeks after intradermal injections of NT 201 with fixed dose and volume, using different delivery methods | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Injection pain intensity as assessed by a 0-10 numeric pain rating scale directly after the intradermal injection of NT 201 applied via different delivery methods in the forehead | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz Therapeutics GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Investigational Site #0490385 | Hamburg | 20095 | Germany |
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Intra-individual comparison
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|
| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
| 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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