Pediculus Capitis
Conditions
Keywords
lice comb, human head lice infestations, combing solution
Brief summary
A one day study to demonstrate that Resultz Lice and Egg Elimination Kit is statistically superior to a sham control with one hour of combing.
Detailed description
Resultz Lice and Egg Elimination Kit will be efficacious in the removal of human head lice infestations in children and adult subjects under simulated real world conditions.
Interventions
DEVICEApply Liquid Then Comb Out
Apply liquid to dry hair, wait for 5 minutes, then comb out lice and eggs for up to one hour
Sponsors
Lice Solutions Resource Network (LSRN) Research
Piedmont Pharmaceuticals, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Must have active head lice infestations (at least 1 live louse and eggs) * Good general health based on medical history * Each subject has to be consented
Exclusion criteria
* Subjects with any condition that would compromise the study * History of irritation or sensitivity to pediculicides or hair care products * Subjects with cranial or facial implants * Subjects who have received radiation within the last 6 months * Subjects with history of heart disease * Subjects with history of epilepsy or seizure disorders * Subjects with neuro-stimulator or pacemaker * Subject with hair that staff cannot comb * Subject previously treated in study in last 30 days * Use of lice treatment in past 2 weeks * Subject unable to sense pain * Subject unable to communicate pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing | 1 hour | A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Lice Removed, Total Number of Eggs Removed | 1 hour | Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Resultz Lice and Egg Removal Kit Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb | 51 |
| Sham Lice and Egg Removal Kit 20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour
Resultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb | 49 |
| Total | 100 |
Baseline characteristics
| Characteristic | Resultz Lice and Egg Removal Kit | Sham Lice and Egg Removal Kit | Total |
|---|---|---|---|
| Age, Continuous | 16.3 years STANDARD_DEVIATION 13.5 | 17.8 years STANDARD_DEVIATION 12.1 | 16.9 years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 40 Participants | 37 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 12 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 51 Participants | 49 Participants | 100 Participants |
| Sex: Female, Male Female | 37 Participants | 44 Participants | 81 Participants |
| Sex: Female, Male Male | 14 Participants | 5 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 49 |
| other Total, other adverse events | 0 / 51 | 0 / 49 |
| serious Total, serious adverse events | 0 / 51 | 0 / 49 |
Outcome results
Primary
The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing
A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control.
Time frame: 1 hour
Population: Intent To Treat; including all subjects who were enrolled in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resultz Lice and Egg Elimination Kit | The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing | 71.3 number of lice and eggs removed | Standard Deviation 61.2 |
| Sham Lice and Egg Elimination Kit | The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing | 26.1 number of lice and eggs removed | Standard Deviation 25.6 |
Comparison: Ho: Total Number of lice and eggs removed with Resultz® ≤ Total number of lice and eggs removed with sham control Ha: Total Number of lice and eggs removed with Resultz® \> Total Number of lice and eggs removed with sham controlp-value: <0.000195% CI: [0.5829, 1.4288]ANOVA
Secondary
Total Number of Lice Removed, Total Number of Eggs Removed
Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately
Time frame: 1 hour
Population: Intent To Treat; including all subjects enrolled
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resultz Lice and Egg Elimination Kit | Total Number of Lice Removed, Total Number of Eggs Removed | 40.3 Number of Lice or Number of Eggs | Standard Deviation 43.6 |
| Sham Lice and Egg Elimination Kit | Total Number of Lice Removed, Total Number of Eggs Removed | 12 Number of Lice or Number of Eggs | Standard Deviation 15.1 |
| Number of Eggs Removed by Resultz | Total Number of Lice Removed, Total Number of Eggs Removed | 31 Number of Lice or Number of Eggs | Standard Deviation 22.3 |
| Number of Eggs Removed by Control | Total Number of Lice Removed, Total Number of Eggs Removed | 14.1 Number of Lice or Number of Eggs | Standard Deviation 11.8 |
Comparison: Comparison of total number of lice removed and total number of eggs removed were analyzed separatelyp-value: <0.000195% CI: [1.1157, 1.3011]GLIMMX
p-value: <0.000195% CI: [0.6993, 0.8805]GLIMMX