A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age

T

Topaz Pharmaceuticals Inc

Status and phase

Completed
Phase 1

Conditions

Head Lice

Treatments

Drug: 0.5% Ivermectin Cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT00988533
TOP008

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

6 months to 3 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

0.5% Ivermectin Cream
Experimental group
Treatment:
Drug: 0.5% Ivermectin Cream

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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