A Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects

Study Overview
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Brief Summary
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The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective treatment for head lice infestations.

Official Title
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A Double-Blind Randomized Study to Compare the Efficacy, Safety, and Local Tolerability of a 0.5% Ivermectin Cream Compared to a Topical Vehicle Control in Subjects With Pediculus Humanus Capitis Infestation

Conditions
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Head Lice

Intervention / Treatment
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* Drug: 0.5% Ivermectin Cream
* Drug: Placebo control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Index subjects must have an active head lice infestation defined as: At least 3 live lice (adults and/or nymphs) present on the scalp and/or hair, as determined by a trained evaluator. The index subject must be the youngest family member presenting with at least 3 live lice. After the index subject has been identified, additional infested household members (see b below) will be enrolled. Household subjects must have an active head lice infestation defined as: At least 1 live louse (adult and/or nymph) present on the scalp and/or hair, as determined by a trained evaluator (with the exception of the male head of household who may self-assess as being lice free). Subject is male or female. Subject is at least 6 months of age at time of enrollment. Subject is in good general health based on medical history. Each subject must have an appropriately signed Informed Consent agreement. A caregiver must sign an Informed Consent agreement for children not old enough to do so. Children of a specified age will be administered a child's assent form. The caregiver of a subject must be willing to allow all household members to be screened for head lice. If other household members are found to have an active head lice infestation, according to the criteria b (above), they must be willing and able to participate in the study. No more than one working male per household may be excluded from evaluation if he is assessed as being lice free by himself or the caregiver and cannot come in due to his work schedule. If this individual may have lice, he must come to the test facility; otherwise the entire household will be excluded from study participation. Subject and/or their caregiver must be physically able and willing to apply the test article. Subject agrees not to use any other form of lice treatments (commercial, community-anecdotal, or mechanical/manual) while participating in the study. Following application and rinsing of the test article, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24-hour post-treatment evaluation has been completed. Subject agrees to not cut or chemically treat their hair while participating in the study. Subject agrees to follow all study instructions. Female subjects of childbearing potential (including a female caregiver even if she is not being treated) must be willing to have a urine pregnancy test. In the event of a subject judged to be incapable of self-treating, the household must have a caregiver willing to apply the treatment at home. Exclusion Criteria: History of irritation or sensitivity to ivermectin or the cream components, pediculicides or hair care products. Presentation at the treatment site with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is >2, blisters, vesicles which, in the opinion of the investigative personnel or sponsor, will interfere with safety and/or efficacy evaluations. Presentation at the treatment site with eczema or atopic dermatitis. Treatment for head lice (over-the-counter [OTC], home remedy and/or Prescription) in the last 7 days. Any condition or illness that, in the opinion of the investigator, may compromise the objective of the protocol. Is receiving any other treatment which, in the opinion of the investigator or study monitor, may interfere with the study results. Females (including caregivers who come in contact with the investigational product) who are pregnant, nursing or planning a pregnancy. (NOTE: female caregivers and all enrolled females of childbearing potential must have a negative urine pregnancy test prior to treatment). If a household has a pregnant female who has an active case of lice, the entire household is excluded from participation. If this pregnant household member does not have an active infestation, this individual must NOT be the caregiver (one who provides treatment to other household members). Is of child-bearing potential and unwilling to use an adequate method of contraception for the duration of the study. Adequate methods of contraception include: abstinence, vasectomized partner, oral birth control pills, birth control injections or patches, intrauterine device, condoms with a spermicidal jelly or a diaphragm with spermicidal jelly, surgical sterilization. Participation in a previous investigational drug study within the past 30 days. Prior participation in any ivermectin trials. Does not understand the requirements for study participation and/or may likely exhibit poor compliance, in the opinion of the investigator. Does not have a known household affiliation with their household members (i.e., do not stay in one household consistently, sleeping at one place several nights and then at another place or location). Household is defined as living in a shared area or space (for example the same house or apartment unit).

Ages Eligible for Study
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Minimum Age: 5 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: 0.5% Ivermectin Cream<br>Up to 4 ounces of topical Ivermectin Cream applied to hair and scalp on day 1 | Drug: 0.5% Ivermectin Cream<br>* Up to 4 ounces of 0.5% Ivermectin Cream applied to hair and scalp on day 1.<br>|
| Placebo Comparator: Vehicle control<br>Up to 4 ounces of topical control applied to hair and scalp on day 1. | Drug: Placebo control<br>* up to 4 ounces of topical vehicle control to head and scalp on day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Treatment success, defined as absence of live lice, was assessed in index subjects, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation. | Day 2 up to Day 15 post-application | 
| Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Treatment success, defined as absence of live lice, was assessed in all subjects. Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation. | Day 2 up to Day 15 post-application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Adverse events were defined and classified as follows: 'Mild' - Awareness of signs or symptoms, but easily tolerated; 'Moderate' - Discomfort to a degree that adverse event/adverse drug reaction causes interference with normal daily life activities and/or requires medication; 'Severe' - Incapacity with regard to work or usual daily life activities. Requires medical attention/intervention. | Day 2 up to Day 15 post-application | 
| Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) | Severe skin/scalp irritations were defined as follows: Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - large areas of the scalp are red; Severe Excoriation - Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp. | Day 2 up to Day 15 post-application | 

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