CompletedPhase 3

A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice

United States296 participantsStarted 2017-10-02

Plain-language summary

This is a phase 3 randomized, multi-center, double-blind, placebo controlled, parallel group design study.

Who can participate

Age range6 Months – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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, through the age of 18, presenting with an active head lice infestation.
✓. Household members that 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) will receive the Standard of Care with an over-the-counter head lice treatment product. Up to 3 infested household members may receive treatment, if more than 3 household members are infested, the entire household will be excluded from the study.
✓. Subject is male or female.
✓. Index subject is at least 6 months through 18 years 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 ages 6-17 years of 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, they must be willing and able to participate in receiving the Standard of Care. 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 product according to established treatment methods.

Exclusion criteria

✕. Index subjects with greater than 3 household members with at least 1 live louse (adult and/or nymph) present on the scalp and/or hair, as determined by a trained evaluator will be automatically excluded from the trial.
✕. Youngest household member is over 18 years of age.
✕. History of irritation or sensitivity to ivermectin or the lotion 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 medical monitor, 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 15 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 medical monitor, may interfere with the study results.

What they're measuring

The Proportion of Index Subjects Who Are Lice Free at Day 15

Timeframe: 15 Days

Trial details

NCT IDNCT03337490

SponsorMayne Pharma International Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-12-04

Results submitted2020-08-13

View on ClinicalTrials.gov More Head Lice trials