Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of Licefreee Spray in eradicating head lice as compared to Nix, both are available over-the-counter lice treatments.
Head lice is a worldwide problem. Many treatments for lice appear to be losing their effectiveness; therefore products are needed that safely and effectively eradicate lice.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Licefreee Spray | Experimental |
| |
| Nix Creme Rinse, 1% Permethrin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Licefreee Spray | Drug | Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice | No live lice 15 days following initial treatment | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of participants with adverse events | 15 days |
Not provided
Inclusion Criteria:
Must be 4 years of age or older
Exclusion Criteria:
Used any form of head lice treatment, prescription, OTC or home remedy for at least four weeks prior to their visit
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lidia Serrano | South Florida Family Health and Research Centers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lice Source Services Inc. | Plantation | Florida | 33313 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Licefreee Spray | Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present. |
| FG001 | Nix Creme Rinse, 1% Permethrin | 1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Licefreee Spray | Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present. |
| BG001 | Nix Creme Rinse, 1% Permethrin |
| 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 Proportion Within Each Treatment Group of Subjects Who Have no Live Lice | No live lice 15 days following initial treatment | Posted | Number | participants | 15 days |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Licefreee Spray | Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Langley | Tec Laboratories, Inc. | 5419264577 | 338 | wendy@teclabsinc.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1% permethrin creme rinse | Drug | Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present. |
|
1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hair Length | Number | participants |
|
| Hair Texture | Number | participants |
|
| Hair Curliness | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Adverse Events | Number of participants with adverse events | Posted | Number | participants | 15 days |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Nix Creme Rinse, 1% Permethrin | 1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present. | 0 | 20 | 0 | 20 |
Not provided
Not provided