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 determine the bioavailability of 0.5% ivermectin cream in a pediatric population aged 6 months to 3 years.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5% Ivermectin Cream | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5% Ivermectin Cream | Drug | Topical 0.5% ivermectin cream applied to scalp and hair on day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points | Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods with a sensitivity of 0.05 ng/mL before application and on Day 1 (0.5, 1, and 6 hours), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application). | Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application |
| Summary of Pharmacokinetic Parameters Following Ivermectin Application. | Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application). | Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application |
| Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application. | Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application). | Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application |
| Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application. | Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application). | Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Adverse events were assessed at each visit and during the follow up phone call on Day 28. | Day 1 up Day 28 post-application |
| Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin. |
Not provided
Inclusion Criteria:
Subject must be 6 months to 3 years of age, inclusive, when informed consent is signed.
Subject must be infested with head lice as demonstrated by the presence of at least 1 live louse prior to treatment.
Subject is in general good health.
Subject's parent/guardian (caregiver) must be willing and able to bring subject to all study visits as scheduled.
Subject's caregiver must have provided written informed consent (assent is not required due to the young age of the subjects).
Subject's caregiver must agree to comply with the following study restrictions:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Topaz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Investigational Research Program | Bentonville | Arkansas | 72712 | United States | ||
| Universal BioPharma Research, Inc |
A total of 30 participants who met the inclusion and exclusion criteria were enrolled and treated.
Participants were enrolled and treated from 22 September 2009 to 18 November 2009 at 3 US clinical centers.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 0.5% Ivermectin | Participants received a single application of 0.5% ivermectin on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 0.5% Ivermectin | Participants received a single application of 0.5% ivermectin on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points | Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods with a sensitivity of 0.05 ng/mL before application and on Day 1 (0.5, 1, and 6 hours), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application). | Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population. | Posted | Mean | Standard Deviation | ng/mL | Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application |
|
Adverse event data were collected from the day of application (Day 1) through Day 28 post-application
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 | 0.5% Ivermectin | Participants received a single application of 0.5% ivermectin on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Topaz | RegistryContactUs@sanofipasteur.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Eradication of live lice was assessed by visual examination of the scalp and hair. |
| Day 2, Day 8 and Day 15 post-application |
| Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin. | Eradication of live lice was assessed by visual examination of the scalp and hair before and following application of Ivermectin. | Day 2, Day 8 and Day 15 post-application |
| Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Liver function tests (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase) were performed before Ivermectin application on Day 1 (baseline) and on Days 2, 8, and 15 after application. | Day 1, Day 2, Day 8 and Day 15 post-application |
| Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Liver function test (total bilirubin) was performed before treatment Day 1 (baseline) and following Ivermectin application on Days 2, 8, and 15 Post-application, respectively. | Day 1, Day 2, Day 8 and Day 15 post-application |
| Dinuba |
| California |
| 93618 |
| United States |
| Impact Clinical Trials | Los Angeles | California | 90036 | United States |
| Lice Source Solutions Inc | Plantation | Florida | 33313 | United States |
| Spence Medical Research L.L.C | Picayune | Mississippi | 39466 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Summary of Pharmacokinetic Parameters Following Ivermectin Application. | Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application). | Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population. | Posted | Mean | Standard Deviation | ng/h/mL | Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application |
|
|
|
| Secondary | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Adverse events were assessed at each visit and during the follow up phone call on Day 28. | Adverse events were assessed in the intent-to-treat population. | Posted | Number | Participants | Day 1 up Day 28 post-application |
|
|
|
| Secondary | Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin. | Eradication of live lice was assessed by visual examination of the scalp and hair. | Eradication of live lice was assessed in the intent-to-treat population. | Posted | Number | Percent of Participants | Day 2, Day 8 and Day 15 post-application |
|
|
|
| Secondary | Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin. | Eradication of live lice was assessed by visual examination of the scalp and hair before and following application of Ivermectin. | Eradication of live lice was assessed in the intent to treat population. | Posted | Number | Percent of Participants | Day 2, Day 8 and Day 15 post-application |
|
|
|
| Secondary | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Liver function tests (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase) were performed before Ivermectin application on Day 1 (baseline) and on Days 2, 8, and 15 after application. | Liver function tests were performed in the intent to treat population. | Posted | Mean | Standard Deviation | U/L | Day 1, Day 2, Day 8 and Day 15 post-application |
|
|
|
| Secondary | Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Liver function test (total bilirubin) was performed before treatment Day 1 (baseline) and following Ivermectin application on Days 2, 8, and 15 Post-application, respectively. | Liver function tests were performed in the intent to treat population. | Posted | Mean | Standard Deviation | mg/dL | Day 1, Day 2, Day 8 and Day 15 post-application |
|
|
|
| Primary | Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application. | Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application). | Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population. | Posted | Mean | Standard Deviation | ng/mL | Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application |
|
|
|
| Primary | Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application. | Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application). | Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population. | Posted | Mean | Standard Deviation | hour | Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application |
|
|
|
| 1 |
| 30 |
| 11 |
| 30 |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Dermatitis Diaper | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA 10.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
|
|
| Severe Vomiting |
|
| Gastroenteritis |
|
| Severe Gastroenteritis |
|
| Nasopharyngitis |
|
| Severe Nasopharyngitis |
|
| Upper Respiratory Tract Infection |
|
| Severe Upper Respiratory Tract Infection |
|
| Alanine Aminotransferase Increased |
|
| Severe Alanine Aminotransferase Increased |
|
| Aspartate Aminotransferase Increased |
|
| Severe Aspartate Aminotransferase Increased |
|
| Dehydration |
|
| Severe Dehydration |
|
| Dermatitis Diaper |
|
| Severe Dermatitis Diaper |
|
| Erythema |
|
| Severe Erythema |
|
| Pruritus |
|
| Severe Pruritus |
|
| Title | Measurements |
|---|
|
|
| Alkaline Phosphatase Day 8 |
|
| Alkaline Phosphatase Change from Day 1 to 8 |
|
| Alkaline Phosphatase Day 15 |
|
| Alkaline Phosphatase Change from Day 1 to 15 |
|
| Alanine Aminotransferase Day 1 |
|
| Alanine Aminotransferase Day 2 |
|
| Alanine Aminotransferase Change from Day 1 to 2 |
|
| Alanine Aminotransferase Day 8 |
|
| Alanine Aminotransferase Change from Day 1 to 8 |
|
| Alanine Aminotransferase Day 15 |
|
| Alanine Aminotransferase Change from Day 1 to 15 |
|
| Aspartate Aminotransferase Day 1 |
|
| Aspartate Aminotransferase Day 2 |
|
| Aspartate Aminotransferase Change from Day 1 to 2 |
|
| Aspartate Aminotransferase Day 8 |
|
| Aspartate Aminotransferase Change from Day 1 to 8 |
|
| Aspartate Aminotransferase Day 15 |
|
| Aspartate Aminotransferase Change from Day 1 to 15 |
|
| Lactate Dehydrogenase Day 1 |
|
| Lactate Dehydrogenase Change Day 2 |
|
| Lactate Dehydrogenase Change from Day 1 to 2 |
|
| Lactate Dehydrogenase Day 8 |
|
| Lactate Dehydrogenase Change from Day 1 to 8 |
|
| Lactate Dehydrogenase 15 |
|
| Lactate Dehydrogenase Change from Day 1 to 15 |
|
| Title | Measurements |
|---|---|
|
| Total Bilirubin Day 8 |
|
| Total Bilirubin Change from Day 1 to 8 |
|
| Total Bilirubin Day 15 |
|
| Total Bilirubin Change from Day 1 to 15 |
|