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The aim of this study is to investigate the efficacy and safety of 1% GPB cream after 4 weeks of treatment compared with placebo with a sufficient number of patients to obtain statistically significant results, and to assess the long-term safety of 1% GPB cream.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WO3970 | Experimental | Formulation containing WO3979 for topical application |
|
| Placebo of WO3988 | Placebo Comparator | Formulation containing Placebo of WO3988 for topical application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WO3970 | Drug | Application of cream to each axilla |
| |
| Placebo (WO3988) |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-confirming part: Absolute change in sweat production assessed by gravimetric measurement (GM) from Baseline (Day 1a) to Day 29 in the 1% GPB group compared with the placebo group. | Baseline (Day 1a), Day 29 | |
| Long-term part (only for newly recruited patients): Absolute change in sweat production assessed by GM from Baseline (Day 1b) to Week 12 | Baseline (Day 1b), Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-confirming part: Percentage of responders assessed by the Hyperhidrosis Disease Severity Scale (HDSS) (≥2-point improvement from Baseline) on Day 29 in the 1% GPB group compared with the placebo group | The Hyperhidrosis Disease Severity Scale (HDSS) is a disease-specific, quick, and easily-understood diagnostic tool that provides a qualitative measure of the severity of the patient's condition based on how it affects daily activities. HDSS is a four item scale. A score of 1 or 2 indicates mild or moderate Hyperhidrosis. A score of 3 or 4 indicates severe Hyperhidrosis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Rolf-Markus Szeimies, MD | Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Harald Brüning | Kiel | 24148 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37280417 | Derived | Donhauser T, Apfelbacher C, Kann G, Masur C, Kamudoni P, Salek S, Abels C, Gabes M. Hyperhidrosis quality of life index (HidroQoL): further validation by applying classical test theory and item response theory using data from a phase III clinical trial. J Patient Rep Outcomes. 2023 Jun 6;7(1):55. doi: 10.1186/s41687-023-00596-6. |
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| Drug |
Application of cream to each axilla |
|
| Day 29 |
| Dose-confirming part: Percentage of responders assessed by GM at Day 29 (defined by sweat reduction of ≥50%, ≥75%, and ≥90% compared with Baseline) in the 1% GPB group compared with the placebo group | Day 29 |
| Long-term part: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12 | Week 12 |
| Long-term part: Percentage of responders assessed by GM at Week 4 and Week 12 (defined by sweat reduction of ≥50%, ≥75%, and ≥90% compared with Baseline | Week 4, Week 12 |
| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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