Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation
Condition: Pediculus Humanus Capitis (Head Lice)
MeSH terms: Lice Infestations
Intervention: ivermectin treatment conditioner; Placebo, vehicle control
Intervention description: Application followed by thorough rinsing of the hair and scalp with water.; Application followed by thorough rinsing of the hair and scalp with water.
Intervention MeSH terms: Ivermectin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No
Keywords: head lice; Pediculus humanus capitis; ivermectin

Summary:

      This is a Phase 2 single center study designed to compare the safety, local tolerability, and
      efficacy of 3 strengths of ivermectin treatment conditioner to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are at least 6 months old and weighing at least 15 kg.

          -  Infestation with head lice and viable nits.

          -  Are otherwise in a normal state of health.

          -  Willing and able to attend all study visits as scheduled.

          -  Agree not to cut or chemically treat their hair in the period between treatment and
             the final visit.

          -  The subject and/or his/her parent/legal guardian have provided written informed
             consent, and, if appropriate, the child has provided assent.

          -  Females of childbearing potential must have a negative urine pregnancy test at
             screening and agree to take reasonable precautions against becoming pregnant during
             the study period.

        Exclusion Criteria:

          -  Subjects who have received any over the counter or prescription treatment for head
             lice in the last 2 weeks.

          -  Subjects unable to comply with the study obligations and all study visits.

          -  Subjects with eczema or other chronic conditions of the scalp and skin.

          -  Subjects in a household with more than 5 infested members.

          -  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 neurologic conditions including a seizure disorder or history of
             seizures.

          -  Subjects with an infestation of body lice or pubic lice (determined by questioning).

          -  Subjects suffering from a condition likely to require medical attention, including
             administration of oral or systemic antibiotics, oral or systemic corticosteroids, or
             any other treatment, which in the opinion of the Investigator and visiting physician
             could influence the results of the study.

          -  Subjects with other diagnoses which, in the opinion of the Investigator, would
             interfere with efficacy or safety assessments or would preclude study participation.

          -  Subjects with very short (shaved) hair.

          -  Subjects who have been treated with a systemic antibiotic within the previous 2 weeks
             before screening.

          -  Subjects who have been previously enrolled in any clinical study within the past 30
             days; subjects may not participate in another study while participating in this study.

          -  Pregnant and/or nursing females.