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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005570-38 | EudraCT Number |
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| Name | Class |
|---|---|
| Nuvisan GmbH | UNKNOWN |
| FGK Clinical Research GmbH | INDUSTRY |
| Charles River Biopharmaceutical Services GmbH | UNKNOWN |
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The aim of the study is to assess the safety, tolerability, pharmacokinetics (PK) and efficacy of escalating concentrations of GPB in subjects with axillary hyperhidrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WO3979 | Experimental | Formulation containing WO3979 for topical application |
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| WO3970 | Experimental | Formulation containing WO3970 for topical application |
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| WO3992 | Experimental | Formulation containing WO3992 for topical application |
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| Placebo of WO3988 | Placebo Comparator | Formulation containing Placebo of WO3988 for topical application |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WO3979 | Drug | Application of cream to each axilla |
| |
| WO3970 |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability and safety assessed through adverse events and local skin reactions | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gravimetric measurement of sweat production | 3 weeks | |
| Dermatology Life Quality Index (DLQI) | 3 weeks | |
| Hyperhidrosis Disease Severity Scale (HDSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Christoph Abels, MD, PhD | Dr. August Wolff GmbH & Co. KG Arzneimittel | Study Director |
| Horst Jürgen Heuer, MD | Nuvisan GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuvisan GmbH | Neu-Ulm | 89231 | Germany |
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| Drug |
Application of cream to each axilla |
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| WO3992 | Drug | Application of cream to each axilla |
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| Placebo (WO3988) | Drug | Application of cream to each axilla |
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| 3 weeks |
| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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