Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neem Lotion With Combing for Lice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02974088
Recruitment Status : Completed
First Posted : November 28, 2016
Results First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborators:
Leeds Health Protection Unit
PN Lee Statistics and Computing Ltd
Nelsons
Information provided by (Responsible Party):
Ian F Burgess, Medical Entomology Centre

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pediculoses
Head Lice
Interventions Device: Neem-based lotion plus louse comb
Device: Neem-based lotion plus grooming comb
Enrollment 47
Recruitment Details Recruitment between 26 May 2006 and 31 August 2006. Community recruitment with domiciliary visits
Pre-assignment Details  
Arm/Group Title Neem-based Lotion Plus Louse Comb Neem-based Lotion Plus Grooming Comb
Hide Arm/Group Description

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 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

Period Title: Overall Study
Started 23 24
Completed 23 21 [1]
Not Completed 0 3
Reason Not Completed
Lost to Follow-up             0             2
Adverse Event             0             1
[1]
Nurse left without notice and took CRFs and data for 2 subjects.
Arm/Group Title Neem-based Lotion Plus Louse Comb Neem-based Lotion Plus Grooming Comb Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 23 24 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 24 participants 47 participants
<=18 years
20
  87.0%
19
  79.2%
39
  83.0%
Between 18 and 65 years
3
  13.0%
5
  20.8%
8
  17.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 24 participants 47 participants
Female
19
  82.6%
22
  91.7%
41
  87.2%
Male
4
  17.4%
2
   8.3%
6
  12.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 23 participants 24 participants 47 participants
23 22 45
1.Primary Outcome
Title Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing
Hide Description Recruitment at Day 0. Success of treatment = No lice present at Day 14 and no lice present at Day 10
Time Frame 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the 15 study days
Arm/Group Title Neem-based Lotion Plus Louse Comb Neem-based Lotion Plus Grooming Comb
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 23 22
Measure Type: Count of Participants
Unit of Measure: Participants
23
 100.0%
22
 100.0%
2.Secondary Outcome
Title Difference in Number of Participants Free From Head Louse Infestation According to Comb Type Used
Hide Description 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
Time Frame 15 days
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Hide Description Number of participants with application site reactions
Time Frame 15 days
Outcome Measure Data Not Reported
Time Frame 15 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Neem-based Lotion Plus Louse Comb Neem-based Lotion Plus Grooming Comb
Hide Arm/Group Description

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 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

All-Cause Mortality
Neem-based Lotion Plus Louse Comb Neem-based Lotion Plus Grooming Comb
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)      0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Neem-based Lotion Plus Louse Comb Neem-based Lotion Plus Grooming Comb
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Neem-based Lotion Plus Louse Comb Neem-based Lotion Plus Grooming Comb
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/23 (4.35%)      1/24 (4.17%)    
Skin and subcutaneous tissue disorders     
Application site reaction * [1]  1/23 (4.35%)  1 1/24 (4.17%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Rash
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ian Burgess
Organization: Medical Entomology Centre
Phone: +44 1223 810070
Responsible Party: Ian F Burgess, Medical Entomology Centre
ClinicalTrials.gov Identifier: NCT02974088     History of Changes
Other Study ID Numbers: CTNC01
First Submitted: November 21, 2016
First Posted: November 28, 2016
Results First Submitted: November 16, 2018
Results First Posted: March 14, 2019
Last Update Posted: March 14, 2019