Trial Outcomes & Findings for A Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit on Pediatric and Adult Subjects (NCT NCT02997904)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

1 hour

Results posted on

2017-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	51	49
Overall Study COMPLETED	51	49
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit on Pediatric and Adult Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Resultz Lice and Egg Removal Kit n=51 Participants 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	Sham Lice and Egg Removal Kit n=49 Participants 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	Total n=100 Participants Total of all reporting groups
Age, Continuous	16.3 years STANDARD_DEVIATION 13.5 • n=93 Participants	17.8 years STANDARD_DEVIATION 12.1 • n=4 Participants	16.9 years STANDARD_DEVIATION 12.9 • n=27 Participants
Sex: Female, Male Female	37 Participants n=93 Participants	44 Participants n=4 Participants	81 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	5 Participants n=4 Participants	19 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=93 Participants	37 Participants n=4 Participants	77 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=93 Participants	12 Participants n=4 Participants	23 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	51 Participants n=93 Participants	49 Participants n=4 Participants	100 Participants n=27 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: Intent To Treat; including all subjects who were enrolled in the study.

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.

Outcome measures

Outcome measures
Measure	Resultz Lice and Egg Elimination Kit n=51 Participants 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	Sham Lice and Egg Elimination Kit n=49 Participants 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	Number of Eggs Removed by Resultz Total number of eggs removed after one hour of combing, analyzed separately	Number of Eggs Removed by Control Total number of eggs removed after one hour of combing by control, analyzed separately
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	26.1 number of lice and eggs removed Standard Deviation 25.6	—	—

SECONDARY outcome

Timeframe: 1 hour

Population: Intent To Treat; including all subjects enrolled

Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately

Outcome measures

Outcome measures
Measure	Resultz Lice and Egg Elimination Kit n=51 Participants 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	Sham Lice and Egg Elimination Kit n=49 Participants 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	Number of Eggs Removed by Resultz n=51 Participants Total number of eggs removed after one hour of combing, analyzed separately	Number of Eggs Removed by Control n=49 Participants Total number of eggs removed after one hour of combing by control, analyzed separately
Total Number of Lice Removed, Total Number of Eggs Removed	40.3 Number of Lice or Number of Eggs Standard Deviation 43.6	12 Number of Lice or Number of Eggs Standard Deviation 15.1	31 Number of Lice or Number of Eggs Standard Deviation 22.3	14.1 Number of Lice or Number of Eggs Standard Deviation 11.8

Adverse Events

Resultz Lice and Egg Removal Kit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Lice and Egg Removal Kit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kathy Palma

Piedmont Pharmaceuticals

Phone: 336 544 0320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Not without sponsor permission
Publication restrictions are in place

Restriction type: OTHER