Trial Outcomes & Findings for Neem Lotion With Combing for Lice (NCT NCT02974088)

NCT ID: NCT02974088

Last Updated: 2024-03-19

Results Overview

Recruitment at Day 0. Success of treatment = No lice present at Day 14 and no lice present at Day 10

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: 15 days
• Results posted on: 2024-03-19

Participant Flow

Recruitment between 26 May 2006 and 31 August 2006. Community recruitment with domiciliary visits

None defined

Participant milestones

Measure	Neem-based Lotion Plus Louse Comb Neem-based conditioning lotion plus head louse detection and removal comb Neem-based lotion plus louse comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb	Neem-based Lotion Plus Grooming Comb Neem-based conditioning lotion plus regular grooming comb Neem-based lotion plus grooming comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb
Overall Study STARTED	23	24
Overall Study COMPLETED	23	21
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	Neem-based Lotion Plus Louse Comb Neem-based conditioning lotion plus head louse detection and removal comb Neem-based lotion plus louse comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb	Neem-based Lotion Plus Grooming Comb Neem-based conditioning lotion plus regular grooming comb Neem-based lotion plus grooming comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb
Overall Study Lost to Follow-up	0	2
Overall Study Adverse Event	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Neem-based Lotion Plus Louse Comb n=23 Participants Neem-based conditioning lotion plus head louse detection and removal comb Neem-based lotion plus louse comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb	Neem-based Lotion Plus Grooming Comb n=24 Participants Neem-based conditioning lotion plus regular grooming comb Neem-based lotion plus grooming comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb	Total n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=23 Participants	19 Participants n=24 Participants	39 Participants n=47 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=23 Participants	5 Participants n=24 Participants	8 Participants n=47 Participants
Age, Categorical >=65 years	0 Participants n=23 Participants	0 Participants n=24 Participants	0 Participants n=47 Participants
Sex: Female, Male Female	19 Participants n=23 Participants	22 Participants n=24 Participants	41 Participants n=47 Participants
Sex: Female, Male Male	4 Participants n=23 Participants	2 Participants n=24 Participants	6 Participants n=47 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	23 participants n=23 Participants	22 participants n=24 Participants	45 participants n=47 Participants

PRIMARY outcome

Timeframe: 15 days

Population: All participants who completed the 15 study days

Recruitment at Day 0. Success of treatment = No lice present at Day 14 and no lice present at Day 10

Outcome measures

Measure	Neem-based Lotion Plus Louse Comb n=23 Participants Neem-based conditioning lotion plus head louse detection and removal comb Neem-based lotion plus louse comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb	Neem-based Lotion Plus Grooming Comb n=22 Participants Neem-based conditioning lotion plus regular grooming comb Neem-based lotion plus grooming comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb
Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing	23 Participants	22 Participants

SECONDARY outcome

Timeframe: 15 days

It was expected that the louse comb group would show a high level of success (elimination of infestation). The measure of efficacy of the neem-based lotion was the relative efficacy observed in the grooming comb group compared with the louse comb group

Outcome measures

Measure	Neem-based Lotion Plus Louse Comb n=23 Participants Neem-based conditioning lotion plus head louse detection and removal comb Neem-based lotion plus louse comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb	Neem-based Lotion Plus Grooming Comb n=24 Participants Neem-based conditioning lotion plus regular grooming comb Neem-based lotion plus grooming comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb
Difference in Number of Participants Free From Head Louse Infestation According to Comb Type Used	23 Participants	22 Participants

SECONDARY outcome

Timeframe: 15 days

Number of participants with application site reactions such as irritation, erythema, or other events related to treatment

Outcome measures

Outcome data not reported

Adverse Events

Neem-based Lotion Plus Louse Comb

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Neem-based Lotion Plus Grooming Comb

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Neem-based Lotion Plus Louse Comb n=23 participants at risk Neem-based conditioning lotion plus head louse detection and removal comb Neem-based lotion plus louse comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb	Neem-based Lotion Plus Grooming Comb n=24 participants at risk Neem-based conditioning lotion plus regular grooming comb Neem-based lotion plus grooming comb: Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb
Skin and subcutaneous tissue disorders Application site reaction	4.3% 1/23 • Number of events 1 • 15 days	4.2% 1/24 • Number of events 1 • 15 days

Additional Information

Ian Burgess

Medical Entomology Centre

Phone: +44 1223 810070

Email: ian@insectresearch.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place