Phase 1
Completed N=30
A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age
Head Lice
Source: ClinicalTrials.gov NCT00988533 ↗
Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Apr 2012
Primary outcomePrimary: Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points — 0.00000; 0.02528; 0.08192; 0.20075 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points |
0.00000; 0.02528; 0.08192; 0.20075; 0.16325; 0.05767 | — |
| PRIMARY Summary of Pharmacokinetic Parameters Following Ivermectin Application. |
0.08708; 6.701; 3.972 | — |
| PRIMARY Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application. |
0.241 | — |
| PRIMARY Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application. |
15.9 | — |
| SECONDARY Number of Participants Reporting Adverse Events Following Ivermectin Treatment |
1; 0; 1; 0; 1; 0 | — |
| SECONDARY Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin. |
97; 90; 89 | — |
| SECONDARY Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin. |
97; 86 | — |
| SECONDARY Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application |
257.9; 258.0; 4.2; 259.1; -2.2; 258.3 | — |
| SECONDARY Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application |
0.3; 0.3; -0.0; 0.3; -0.0; 0.3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00988533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.