The purpose of this study is to compare the safety and efficacy of a 0. 5% ivermectin cream
to a placebo in subjects infested with head lice when used in an "at home" environment.
Inclusion Criteria:
- Subject 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 weighs at least 15kg (33 lbs).
- 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 a (above), they must be willing and able
to participate in the study. No more than one working male per family may be
excluded from evaluation if he is self-assessed as being lice free 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 they are participating in the study.
- Following application and rinsing of Study Treatment, subject agrees not to shampoo,
wash, or rinse their hair or scalp until the 24-hour post-treatment evaluation has
been completed.
- Subject agrees that they will not cut or chemically treat their hair while they are
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 on the
skin/scalp.
- Treatment with a marketed pediculicide (Over the counter [OTC] 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, Intra Uterine Devices, 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.
- 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).
Cactus Kids Pediatrics, Yuma, Arizona 85364, United States
Impact Clinical Trials, Los Angeles, California 90057, United States
Lice Cleanique, LLC, Delray Beach, Florida 33484, United States
Hill-Top Research Corp, St Petersburg, Florida 33710, United States
LSRN, West Palm Beach, Florida 33407, United States
Minnesota Clinical Study Center, Fridley, Minnesota 55432, United States
Lovelace Scientific Resources, Inc., Albuquerque, New Mexico 87108, United States
Haywood Pediatric Adolescent Medicine Group, PA, Clyde, North Carolina 28721, United States
Hill Top Research Corp., Miamiville, Ohio 45147, United States
LSRN, Nashville, Tennessee 37206, United States
Northeast Houston Pediatric Clinic, Houston, Texas 77015, United States
Virgina Clinical Research, Inc., Norfolk, Virginia 23507, United States
