Status:
COMPLETED
A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age
Lead Sponsor:
Topaz Pharmaceuticals Inc
Conditions:
Head Lice
Eligibility:
All Genders
6-3 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00988533
Start Date
September 1 2009
End Date
November 1 2009
Last Update
April 25 2012
Active Locations (5)
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1
Children's Investigational Research Program
Bentonville, Arkansas, United States, 72712
2
Universal BioPharma Research, Inc
Dinuba, California, United States, 93618
3
Impact Clinical Trials
Los Angeles, California, United States, 90036
4
Lice Source Solutions Inc
Plantation, Florida, United States, 33313