Head Lice
Conditions
Keywords
Head Lice, Pediculus
Brief summary
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.
Interventions
Topical 0.5% ivermectin cream applied to scalp and hair on day 1
Sponsors
Topaz Pharmaceuticals Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 3 Years
Healthy volunteers
No
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: * will not use any other form of lice treatment (eg, commercial, community/anecdotal, or mechanical/manual) on the subject for the duration of the study, unless directed to do so by study personnel. * will not shampoo, wash, or rinse the subject's hair or scalp until the Day 2 treatment evaluation has been completed. * will not cut or chemically treat subject's hair in the period between screening and follow-up on Day 15. * will use only study-provided shampoo on the subject for the duration of the study. * will follow all study instructions.
Exclusion criteria
* Subjects who have received any OTC or prescription treatment for head lice in the last 2 weeks. * Subjects or subjects' caregivers who are unable to comply with the study obligations and all study visits. * Subjects whose caregivers do not understand the requirements for participation and/or may be likely to exhibit poor compliance, in the opinion of the Investigator. * Subjects with eczema, atopic dermatitis, or other chronic conditions of the scalp and skin. * Subjects with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is \> 2, blisters, or any other condition that, in the opinion of the investigative personnel or Sponsor, would interfere with the PK, safety and/or efficacy evaluations. * Subjects with a history of allergy to ivermectin or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids. * Subjects with other diagnoses that, in the opinion of the Investigator, would interfere with the PK, safety, and/or efficacy assessments or would preclude study participation. * Subjects who have been treated with a systemic antibiotic within 2 weeks before screening. * Subject currently taking warfarin sodium (Coumadin®) or has taken within 2 weeks before screening. * Subjects who have been enrolled in any clinical study within the past 30 days; subjects may not participate in another study while participating in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points | Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application | 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). |
| Summary of Pharmacokinetic Parameters Following Ivermectin Application. | Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-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). |
| Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application. | Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-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). |
| Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application. | Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Day 1 up Day 28 post-application | Adverse events were assessed at each visit and during the follow up phone call on Day 28. |
| Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Day 1, Day 2, Day 8 and Day 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. |
| Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin. | Day 2, Day 8 and Day 15 post-application | Eradication of live lice was assessed by visual examination of the scalp and hair. |
| Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin. | Day 2, Day 8 and Day 15 post-application | Eradication of live lice was assessed by visual examination of the scalp and hair before and following application of Ivermectin. |
| Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Day 1, Day 2, Day 8 and Day 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. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled and treated from 22 September 2009 to 18 November 2009 at 3 US clinical centers.
Pre-assignment details
A total of 30 participants who met the inclusion and exclusion criteria were enrolled and treated.
Participants by arm
| Arm | Count |
|---|---|
| 0.5% Ivermectin Participants received a single application of 0.5% ivermectin on Day 1. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | 0.5% Ivermectin |
|---|---|
| Age, Categorical <=18 years | 30 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 25.8 Months STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 30 |
| serious Total, serious adverse events | 1 / 30 |
Outcome results
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).
Time frame: Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application
Population: Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5% Ivermectin | Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points | 0 Hour (N = 20) | 0.00000 ng/mL | Standard Deviation 0 |
| 0.5% Ivermectin | Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points | 0.5 Hour (N = 19) | 0.02528 ng/mL | Standard Deviation 0.11018 |
| 0.5% Ivermectin | Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points | 1 Hour (N = 19) | 0.08192 ng/mL | Standard Deviation 0.22695 |
| 0.5% Ivermectin | Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points | 6 Hours (N = 19) | 0.20075 ng/mL | Standard Deviation 0.20456 |
| 0.5% Ivermectin | Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points | 24 Hours (N = 18) | 0.16325 ng/mL | Standard Deviation 0.08983 |
| 0.5% Ivermectin | Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points | 168 Hours (N = 2) | 0.05767 ng/mL | — |
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).
Time frame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application
Population: Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.5% Ivermectin | Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application. | 0.241 ng/mL | Standard Deviation 0.23372 |
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).
Time frame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application
Population: Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5% Ivermectin | Summary of Pharmacokinetic Parameters Following Ivermectin Application. | Time Averaged Plasma Concentration | 0.08708 ng/h/mL | Standard Deviation 0.11102 |
| 0.5% Ivermectin | Summary of Pharmacokinetic Parameters Following Ivermectin Application. | Area Under Plasma Concentration Last | 6.701 ng/h/mL | Standard Deviation 11.23 |
| 0.5% Ivermectin | Summary of Pharmacokinetic Parameters Following Ivermectin Application. | Area Under Plasma Concentration 0 to 24 | 3.972 ng/h/mL | Standard Deviation 3.5142 |
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).
Time frame: Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application
Population: Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.5% Ivermectin | Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application. | 15.9 hour | Standard Deviation 10 |
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.
Time frame: Day 1, Day 2, Day 8 and Day 15 post-application
Population: Liver function tests were performed in the intent to treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5% Ivermectin | Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Total Bilirubin - Day 1 | 0.3 mg/dL | Standard Deviation 0.3 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Total Bilirubin Day 2 | 0.3 mg/dL | Standard Deviation 0.3 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Total Bilirubin Change from Day 1 to 2 | -0.0 mg/dL | Standard Deviation 0.1 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Total Bilirubin Day 8 | 0.3 mg/dL | Standard Deviation 0.3 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Total Bilirubin Change from Day 1 to 8 | -0.0 mg/dL | Standard Deviation 0.1 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Total Bilirubin Day 15 | 0.3 mg/dL | Standard Deviation 0.3 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Total Bilirubin Change from Day 1 to 15 | -0.1 mg/dL | Standard Deviation 0.2 |
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.
Time frame: Day 1, Day 2, Day 8 and Day 15 post-application
Population: Liver function tests were performed in the intent to treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Alkaline Phosphatase - Day 1 | 257.9 U/L | Standard Deviation 59.5 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Alkaline Phosphatase Day 2 | 258.0 U/L | Standard Deviation 58.4 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Alkaline Phosphatase Change from Day 1 to 2 | 4.2 U/L | Standard Deviation 16.5 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Alkaline Phosphatase Day 8 | 259.1 U/L | Standard Deviation 51 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Alkaline Phosphatase Change from Day 1 to 8 | -2.2 U/L | Standard Deviation 28.4 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Alkaline Phosphatase Day 15 | 258.3 U/L | Standard Deviation 52.6 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Alkaline Phosphatase Change from Day 1 to 15 | -2.9 U/L | Standard Deviation 32.3 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Alanine Aminotransferase Day 1 | 25.0 U/L | Standard Deviation 20.5 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Alanine Aminotransferase Day 2 | 25.7 U/L | Standard Deviation 20.9 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Alanine Aminotransferase Change from Day 1 to 2 | 0.2 U/L | Standard Deviation 20.9 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Alanine Aminotransferase Day 8 | 25.1 U/L | Standard Deviation 22.1 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Alanine Aminotransferase Change from Day 1 to 8 | -0.2 U/L | Standard Deviation 5.3 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Alanine Aminotransferase Day 15 | 24.1 U/L | Standard Deviation 15.5 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Alanine Aminotransferase Change from Day 1 to 15 | -1.1 U/L | Standard Deviation 8.9 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Aspartate Aminotransferase Day 1 | 42.6 U/L | Standard Deviation 15.4 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Aspartate Aminotransferase Day 2 | 41.1 U/L | Standard Deviation 11.5 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Aspartate Aminotransferase Change from Day 1 to 2 | -2.0 U/L | Standard Deviation 15.4 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Aspartate Aminotransferase Day 8 | 40.3 U/L | Standard Deviation 14 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Aspartate Aminotransferase Change from Day 1 to 8 | -2.3 U/L | Standard Deviation 6.8 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Aspartate Aminotransferase Day 15 | 39.5 U/L | Standard Deviation 9.6 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Aspartate Aminotransferase Change from Day 1 to 15 | -2.7 U/L | Standard Deviation 10.2 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Lactate Dehydrogenase Day 1 | 308.0 U/L | Standard Deviation 87.5 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Lactate Dehydrogenase Change Day 2 | 295.2 U/L | Standard Deviation 35.8 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Lactate Dehydrogenase Change from Day 1 to 2 | -16.8 U/L | Standard Deviation 95.1 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Lactate Dehydrogenase Day 8 | 295.1 U/L | Standard Deviation 54 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Lactate Dehydrogenase Change from Day 1 to 8 | -10.7 U/L | Standard Deviation 80.2 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Lactate Dehydrogenase 15 | 294.5 U/L | Standard Deviation 61.3 |
| 0.5% Ivermectin | Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application | Lactate Dehydrogenase Change from Day 1 to 15 | -9.2 U/L | Standard Deviation 69 |
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.
Time frame: Day 1 up Day 28 post-application
Population: Adverse events were assessed in the intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Diarrhea | 1 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Severe Diarrhea | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Vomiting | 1 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Severe Vomiting | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Gastroenteritis | 1 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Severe Gastroenteritis | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Nasopharyngitis | 2 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Severe Nasopharyngitis | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Upper Respiratory Tract Infection | 2 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Severe Upper Respiratory Tract Infection | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Alanine Aminotransferase Increased | 2 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Severe Alanine Aminotransferase Increased | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Aspartate Aminotransferase Increased | 1 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Severe Aspartate Aminotransferase Increased | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Dehydration | 1 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Severe Dehydration | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Dermatitis Diaper | 1 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Severe Dermatitis Diaper | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Erythema | 5 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Severe Erythema | 0 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Pruritus | 1 Participants |
| 0.5% Ivermectin | Number of Participants Reporting Adverse Events Following Ivermectin Treatment | Severe Pruritus | 0 Participants |
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.
Time frame: Day 2, Day 8 and Day 15 post-application
Population: Eradication of live lice was assessed in the intent to treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.5% Ivermectin | Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin. | Eradication by Day 2 (N = 30) | 97 Percent of Participants |
| 0.5% Ivermectin | Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin. | Eradication Maintained Through Day 8 and 15 (N=29) | 86 Percent of Participants |
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.
Time frame: Day 2, Day 8 and Day 15 post-application
Population: Eradication of live lice was assessed in the intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.5% Ivermectin | Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin. | Day 15 (N = 28) | 89 Percent of Participants |
| 0.5% Ivermectin | Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin. | Day 2 (N = 30) | 97 Percent of Participants |
| 0.5% Ivermectin | Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin. | Day 8 (N = 29) | 90 Percent of Participants |