Clinical Endpoint Study of Ivermectin 0.5% Lotion

Inclusion Criteria:

1. Signed Institutional Review Board (IRB)-approved informed consent form that meets all
criteria of current Food and Drug Administration regulations. For patients who are
considered minors in the state the study is being conducted (< 18 years in most
states), the parent or legal guardian should sign the consent form and the child will
be required to sign a patient "assent" form, as appropriate. Patients 11-17 years of
age will read and sign an IRB-approved assent form and patients 6-10 years of age will
provide verbal assent. Patients 6 months-5 years of age will be exempt from providing
assent based on the child's comprehension and cognitive skills.

2. The patient and/or the patient's parent (legal guardian) is willing to apply the study
product as directed, comply with study instructions and commit to all follow-up visits
for the duration of the study.

3. Male or non-pregnant, non-lactating female, 6 months of age or older.

4. Females of childbearing potential must not be pregnant or lactating at Visit 1 (as
confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/mL
or equivalent units of human chorionic gonadotropin). Women of childbearing potential
must agree to the use of a reliable method of contraception. (e.g., total abstinence,
intrauterine device, a double-barrier method, oral, transdermal, injected, or
implanted non-hormonal or hormonal contraceptive) throughout the study. Female
patients using hormonal contraceptives should have been on the same product/dosing
regimen for at least 28 days before Visit 1 and should not change this regimen during
the study. A sterile sexual partner is not considered an adequate form of birth
control.

5. Index patients (i.e., the youngest household member) must have an active head lice
infestation, defined as ≥ 3 live lice (i.e., live adults and/or nymphs), at Visit 1.

6. Household members participating in the study must have at least one live louse (i.e.,
live adults and/or nymphs) at Visit 1.

7. All members of the household must be present for examination. Any male head of
household who is unable to attend Visit 1 may be assessed by a second member of the
household as being lice free.

Exclusion Criteria:

1. Females who are pregnant, lactating or planning to become pregnant during the study
period.

2. Patients who do 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).

3. Any infested member of the household is unable or unwilling to be treated with the
study product. This includes male heads of household who do not attend Visit 1 but
report infestation with lice.

4. More than three members of the household infested with lice.

5. Presence of visible skin/scalp condition(s) or open wounds at the application site
that are not attributable to head lice infestation and that in the opinion of the
Investigator will interfere with safety and/or efficacy evaluations.

6. Presence of eczema or atopic dermatitis at the application site.

7. Use of any prescription, over-the-counter, or home remedies for the treatment of head
lice within 7 days before Visit 1.

8. Use of pediculicides within four weeks before Visit 1.

9. Use of systemic anti-parasitic agents within four weeks before Visit 1.

10. Patients with very short (shaved) hair or who are planning to shave head during the
study.

11. Use of any hair dye, bleaches, hair straightening or permanent wave solution on the
hair within 14 days before Visit 1.

12. History of allergy or sensitivity to pediculicides or hair care products.

13. History of any drug hypersensitivity or intolerance that, in the opinion of the
Investigator, would compromise the safety of the patient or results of the study.

14. Significant history or current acute or chronic infectious disease, system disorder,
Netherton's Syndrome, organ disorder (e.g., hepatic or renal impairment) or
insufficiency, immunosuppression (from medical treatment or disease), organ
transplant, uncontrolled diabetes, uncontrolled hypertension, current ocular
condition, or other medical condition that, in the Investigator's opinion, would place
the study patient at undue risk by participating in the study.

15. Patients or non-infested household members who would act as the primary caregiver who
are of intellectually competent age but unable to understand the protocol
requirements, instructions, and study-related restrictions, the nature, scope, and
possible consequences of the clinical study.

16. Receipt of any drug as part of a research study within 30 days before Visit 1.

17. The patient is a member of the investigational study staff or a member of the family
of the investigational study staff.

18. Previous participation in this study.