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This Phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing medication and identify the dose or doses that may effectively reduce axillary sweating in hyperhidrotic subjects. The anticholinergic agent being studied is designated WL8713.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WL8713, 6 mg | Experimental | 6 mg WL8713 administered daily |
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| WL8713, 12 mg | Experimental | 12 mg WL8713 administered daily |
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| WL8713, 18 mg | Experimental | 18 mg WL8713 administered daily |
|
| WL8713, 24 mg | Experimental | 24 mg WL8713 administered daily |
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| Placebo | Placebo Comparator | placebo administered daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WL8713, 6 mg | Drug |
| ||
| WL8713, 12 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Gravimetric measurement of sweat production | Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperhidrosis Disease Severity Scale (HDSS) scores | Percentage of subjects with a change from baseline in HDSS scores of at least -2 points at Week 6 (LOCF) | 6 weeks |
| Dermatology Life Quality Index (DLQI) scores |
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Inclusion Criteria:
Healthy volunteers with primary axillary hyperhidrosis
Poor quality of life rating on the Hyperhidrosis Disease Severity Scale (score of 3 or 4)
Has a baseline gravimetric measurement of spontaneous resting sweat production of ≥100 mg/10 min at room at room temperature in at least one axilla
Meets at least two of the following criteria (self-reported):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Watson Clinical Site | San Diego | California | United States |
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| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| WL8713, 18 mg | Drug |
|
| WL8713, 24 mg | Drug |
|
| Placebo | Drug |
|
Change from baseline in DLQI total score at Week 6 (LOCF)
| 6 weeks |
| Global Assessment of Disease State responses | Global Assessment of Disease State score at Week 6 (LOCF) | 6 weeks |