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| Name | Class |
|---|---|
| Lice Solutions Resource Network (LSRN) Research | UNKNOWN |
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A one day study to demonstrate that Resultz Lice and Egg Elimination Kit is statistically superior to a sham control with one hour of combing.
Resultz Lice and Egg Elimination Kit will be efficacious in the removal of human head lice infestations in children and adult subjects under simulated real world conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resultz Lice and Egg Elimination Kit | Experimental | Resultz combing solution, head lice comb and instructions for use in a kit: apply liquid then comb out for 1 hour |
|
| Placebo Lice and Egg Elimination Kit | Placebo Comparator | 20% glycerin combing solution, comb and instructions for use in a kit: apply liquid then comb out for 1 hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apply Liquid Then Comb Out | Device | Apply liquid to dry hair, wait for 5 minutes, then comb out lice and eggs for up to one hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing | A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Lice Removed, Total Number of Eggs Removed | Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katie Shepherd | Lice Solutions Resource Network Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lice Solution Resource Network Research | West Palm Beach | Florida | 33407 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Resultz Lice and Egg Removal Kit | Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb |
| FG001 | Sham Lice and Egg Removal Kit | 20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Resultz Lice and Egg Removal Kit | Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb |
| BG001 | Sham Lice and Egg Removal Kit |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing | A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control. | Intent To Treat; including all subjects who were enrolled in the study. | Posted | Mean | Standard Deviation | number of lice and eggs removed | 1 hour |
|
1 Day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Resultz Lice and Egg Removal Kit | Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathy Palma | Piedmont Pharmaceuticals | 336 544 0320 | 202 | kpalma@piedmontpharma.com |
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|
20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb |
|
|
|
| Secondary | Total Number of Lice Removed, Total Number of Eggs Removed | Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately | Intent To Treat; including all subjects enrolled | Posted | Mean | Standard Deviation | Number of Lice or Number of Eggs | 1 hour |
|
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Sham Lice and Egg Removal Kit | 20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb | 0 | 49 | 0 | 49 | 0 | 49 |
Not without sponsor permission
| GLIMMX |
| <0.0001 |
| Least Squares Mean Difference |
| 0.7899 |
| Standard Error of the Mean |
| 0.04565 |
| 2-Sided |
| 95 |
| 0.6993 |
| 0.8805 |
| Superiority |