Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of 3 Strengths of Ivermectin Treatment Conditioner and Placebo in Subjects With Pediculus Humanus Capitis (Head Lice) Infestation

Conditions
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Pediculus Humanus Capitis (Head Lice)

Intervention / Treatment
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* Drug: ivermectin treatment conditioner
* Drug: Placebo, vehicle control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.15% ivermectin<br>Participant on 0.15% ivermectin treatment conditioner | Drug: ivermectin treatment conditioner<br>* Application followed by thorough rinsing of the hair and scalp with water.<br>|
| Experimental: 0.25% ivermectin<br>Participants on 0.25% ivermectin treatment conditioner | Drug: ivermectin treatment conditioner<br>* Application followed by thorough rinsing of the hair and scalp with water.<br>|
| Experimental: 0.50% ivermectin<br>Participants on 0.50% ivermectin treatment conditioner | Drug: ivermectin treatment conditioner<br>* Application followed by thorough rinsing of the hair and scalp with water.<br>|
| Placebo Comparator: Placebo<br>participants on Placebo (Vehicle control) | Drug: Placebo, vehicle control<br>* Application followed by thorough rinsing of the hair and scalp with water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Live lice eradication was assessed by visual checks of hair and scalp on Days 1, 2 and 8 and by visual checks and counting both live and dead lice from rinse water on Day 15. Eradication was defined as cessation of motility (antennae and leg movement) in all lice. | Day 1 through Day 15 post-application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Live lice eradication was assessed on Days 1, 2, and 8 by visual checks of hair and scalp. Eradication was defined as cessation of motility (antennae and leg movement) in all lice. | Day 1 through Day 8 post-application | 
| Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) | The severity of lice infestation was determined by visual checks of hair and scalp. Severity was rated as None: no live lice; Mild: 1 to 5 live lice; Moderate: 6 to 10 live lice; Severe: 11 to 20 live lice; or Very severe > 20 live lice. | Day 1 through Day 15 post-application | 
| Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). |  | Day 1 up to Day 28 post-application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head lice, Pediculus humanus capitis, ivermectin