Head Lice
Conditions
Keywords
Lice
Brief summary
* To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric population. * To evaluate the safety of LiceMD in a pediatric population.
Detailed description
Head lice, or Pediculus humanus capitis, cause an estimated 6 to 12 million infestations per year in the U.S., most commonly affecting children 3 to 11 years of age. Despite common perceptions, head lice crawl, and cannot hop or fly. For this reason, transmission occurs most often by human head-to-head contact, and much less commonly by the sharing of personal items such as hats, coats, combs, or towels. Because head lice feed on human blood, they cannot live on pets and are only viable 1-2 days on surfaces other than the human head.
Interventions
DRUGLICEMD
Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. Participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application.
DRUGStandard Head lice product
The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products.After baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may purchase any other head lice treatment of their choice. All treatments are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any examination, the school nurse will instruct the parent/guardian to retreat.
Sponsors
Hackensack Meridian Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Subject Inclusion Criteria * Current lice infestation, confirmed by school nurse. Must have live lice - not just eggs. A minimum of one live louse and 10 viable eggs must be seen or three live lice. * Male or female child; age 3 - 12 * Willing to participate in study, and parent/guardian sign informed consent * Parent/guardian must be able to read and follow directions and complete all questionnaires * For children/parents who agree to the experimental arm of the study, agree not to use any other head lice product or home remedy lice treatment during the study.
Exclusion criteria
* No live lice, only eggs. * Less than three live lice observed with less than ten viable eggs * No hair on the head * Buzz cut or crew cut * Use of other lice treatment or home remedy lice treatment within the past 4 weeks * Chronic scalp disorder (such as psoriasis) that would limit the school nurse's ability to detect lice and/or identify adverse events * Currently taking an antibiotic * Does not follow instructions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Free of Live Head Lice and Free of Viable Eggs | Day after first treatment and Day 14 of study | A determination of head lice effectiveness, measured by number of subjects free of live lice and by number of subjects free of viable eggs, was calculated using two week post-treatment data as the primary study outcome. Measurements were calculated at Day 1 (day after first treatment) and Day 14. At diagnosis, 55 subjects had viable eggs with three subjects meeting enrollment criteria for three or more live lice. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LiceMD Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.
LiceMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at day seven and day fourteen after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat. | 58 |
| Standard Head Lice Product Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.
Standard head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at day seven and day fourteen after the first application. | 0 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not have Live Lice | 8 | 0 |
| Overall Study | Did not meet Inclusion Criteria | 6 | 0 |
| Overall Study | Did not Return to School | 5 | 0 |
| Overall Study | Documentation Issue at Enrollment | 1 | 0 |
| Overall Study | Documentation Issue during Study | 10 | 0 |
| Overall Study | Had another Treatment during the Study | 3 | 0 |
| Overall Study | Protocol was not Followed at Enrollment | 5 | 0 |
| Overall Study | Protocol was not Followed during Study | 1 | 0 |
Baseline characteristics
| Characteristic | Total | LiceMD |
|---|---|---|
| Age, Categorical <=18 years | 58 participants | 58 participants |
| Age, Categorical >=65 years | 0 participants | 0 participants |
| Age, Categorical Between 18 and 65 years | 0 participants | 0 participants |
| Age, Continuous | 6.98 Years STANDARD_DEVIATION 1.73 | 6.98 Years STANDARD_DEVIATION 1.73 |
| Gender Female | 45 participants | 45 participants |
| Gender Male | 13 participants | 13 participants |
| Region of Enrollment United States | 58 participants | 58 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 97 | 0 / 0 |
| serious Total, serious adverse events | 0 / 97 | 0 / 0 |
Outcome results
Primary
Number of Participants Free of Live Head Lice and Free of Viable Eggs
A determination of head lice effectiveness, measured by number of subjects free of live lice and by number of subjects free of viable eggs, was calculated using two week post-treatment data as the primary study outcome. Measurements were calculated at Day 1 (day after first treatment) and Day 14. At diagnosis, 55 subjects had viable eggs with three subjects meeting enrollment criteria for three or more live lice.
Time frame: Day after first treatment and Day 14 of study
Population: There were 58 evaluable subjects in the experimental (LiceMD) arm of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LiceMD | Number of Participants Free of Live Head Lice and Free of Viable Eggs | Day 1 Free of live lice | 57 Participants |
| LiceMD | Number of Participants Free of Live Head Lice and Free of Viable Eggs | Day 14 Free of live lice | 55 Participants |
| LiceMD | Number of Participants Free of Live Head Lice and Free of Viable Eggs | Day 1 Free of viable eggs | 32 Participants |
| LiceMD | Number of Participants Free of Live Head Lice and Free of Viable Eggs | Day 14 Free of viable eggs | 46 Participants |