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The purpose of this study was to evaluate the efficacy of a dimethicone foam in the control of head lice and to compare the efficacy to a permethrin based product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 4% dimethicone foam |
|
| 2 | Active Comparator | 1% permethrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4% dimethicone foam | Other | The dimethicone foam is applied to dry hair and left on the hair for approximately 15 minutes. The product is then removed by washing the hair with baby shampoo. The foam is applied two time, separated by an interval of 7-9 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate at the final visit (Day 14 or 15). Cure rate was defined as the number of subjects free of live head lice divided by the total number of subjects in the treatment group (x 100). | 14 or 15 days after 1st treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Any adverse events during or after application of the product | up to 7 or 8 d after product application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lidia Serrano, CRI | Lice Source Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lice Source Services Inc | Plantation | Florida | 33313 | United States |
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| ID | Term |
|---|---|
| D026023 | Permethrin |
| ID | Term |
|---|---|
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 |
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|
| 1% permethrin | Other | Nix® Cream Rinse is applied as indicated on the product labeling. The cream rinse is applied to wet hair and left on the hair for 10 minutes. The hair is then rinsed with tepid water to remove the product, toweled dry, and combed with a detangling comb. The product is applied two times, separated by an interval of 7-9 days. |
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| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011722 | Pyrethrins |
| D000081004 | Cyclopentane Monoterpenes |
| D039821 | Monoterpenes |
| D013729 | Terpenes |