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Trial record 10 of 10 for:    Malathion

Pediatric Head Lice Study Product Comparison

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ClinicalTrials.gov Identifier: NCT02213055
Recruitment Status : Completed
First Posted : August 11, 2014
Results First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Head Lice
Interventions: Drug: LICEMD
Drug: Standard Head lice product

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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 seven and fourteen days 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.

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 seven and fourteen days after the first application.


Participant Flow:   Overall Study
    LICEMD   Standard Head Lice Product
STARTED   97   0 
COMPLETED   58   0 
NOT COMPLETED   39   0 
Protocol was not Followed at Enrollment                5                0 
Protocol was not Followed during Study                1                0 
Documentation Issue at Enrollment                1                0 
Documentation Issue during Study                10                0 
Did not have Live Lice                8                0 
Had another Treatment during the Study                3                0 
Did not meet Inclusion Criteria                6                0 
Did not Return to School                5                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
There were 58 evaluable subjects in the experimental (LiceMD) arm of the study.

Reporting Groups
  Description
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.

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.

Total Total of all reporting groups

Baseline Measures
   LiceMD   Standard Head Lice Product   Total 
Overall Participants Analyzed 
[Units: Participants]
 58   0   58 
Age 
[Units: Participants]
     
<=18 years   58      58 
Between 18 and 65 years   0      0 
>=65 years   0      0 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 6.98  (1.73)      6.98  (1.73) 
[1] There were 58 evaluable subjects in the experimental (LiceMD) arm of the study.
Gender 
[Units: Participants]
     
Female   45      45 
Male   13      13 
Region of Enrollment 
[Units: Participants]
     
United States   58      58 


  Outcome Measures

1.  Primary:   Number of Participants Free of Live Head Lice and Free of Viable Eggs   [ Time Frame: Day after first treatment and Day 14 of study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Project Manager, Environmental Research
Organization: The Deirdre Imus Environmental Health Center at HackensackUMC
phone: 551-996-8071
e-mail: dimuscenter@hackensackumc.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT02213055     History of Changes
Other Study ID Numbers: Pro00000685
First Submitted: August 7, 2014
First Posted: August 11, 2014
Results First Submitted: March 30, 2016
Results First Posted: July 29, 2016
Last Update Posted: July 29, 2016