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A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5%
A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5% to Sklice (Ivermectin) Lotion, 0.5% and both active treatment to a placebo control in the treatment of subjects with active infestation with head lice and their Ova
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin Lotion, 0.5% | Experimental | One 10 minute application, under at-home use conditions |
|
| SKLICE (ivermectin) Lotion, 0.5% | Active Comparator | One 10 minute application, under at-home use conditions |
|
| Vehicle of the Test product | Placebo Comparator | One 10 minute application, under at-home use conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin Lotion, 0.5% | Drug | Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration of Bioequivalence in proportion of index subjects who are lice free | Demonstration of Bioequivalence in proportion of index subjects who are lice free | Day 15 (14 days after application of study treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catawba Research | http://catawbaresearch.com/contact/ | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taro Pharmaceuticals USA Inc. | Hawthorne | New York | 10532 | United States |
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| ID | Term |
|---|---|
| D010373 | Lice Infestations |
| ID | Term |
|---|---|
| D004478 | Ectoparasitic Infestations |
| D012876 | Skin Diseases, Parasitic |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| SKLICE (ivermectin) Lotion, 0.5% | Drug | SKLICE (ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC) |
|
|
| Vehicle of the Test product | Drug | Vehicle for Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.) |
|
|
| D012874 |
| Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |