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Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head 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: NCT00752973
Recruitment Status : Completed
First Posted : September 16, 2008
Results First Posted : April 3, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pediculosis
Intervention: Drug: MALG (malathion) Treatment

  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
Malathion Gel 0.5% Treatment Arm

Malathion Gel 0.5% treatment

MALG (Malathion Gel 0.5%) Treatment: MALG applied for 30 minutes


Participant Flow:   Overall Study
    Malathion Gel 0.5% Treatment Arm
STARTED   12 
COMPLETED   12 
NOT COMPLETED   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.
No text entered.

Reporting Groups
  Description
MALG Treatment Arm

MALG treatment

MALG (malathion) Treatment: MALG applied for 30 minutes


Baseline Measures
   MALG Treatment Arm 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Months]
Mean (Standard Deviation)
 17.5  (4.64) 
Gender 
[Units: Participants]
 
Female   10 
Male   2 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   9 
More than one race   1 
Unknown or Not Reported   2 


  Outcome Measures

1.  Primary:   Participants With a Change in Cholinesterase Level at 1 Hour (Day 0).   [ Time Frame: Change from Baseline to 1 hour ]

2.  Primary:   Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day).   [ Time Frame: Change from baseline to 24 hrs (1 day) ]

3.  Primary:   Participants With the Clinical Evidence of Cholinesterase Inhibition   [ Time Frame: at Baseline ]

4.  Primary:   Participants With the Clinical Evidence of Cholinesterase Inhibition   [ Time Frame: at 1 hr (Day 0) ]

5.  Primary:   Participants With the Clinical Evidence of Cholinesterase Inhibition   [ Time Frame: at 24 hrs (Day 1) ]

6.  Primary:   Participants Clinically Cured of Head Lice 14 Days After Last Treatment   [ Time Frame: Day 7±1 and Day 14 or Day 21 ]

7.  Secondary:   Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions.   [ Time Frame: Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments) ]


  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
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  More Information

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: Director, Clinical Research
Organization: Taro Pharmaceuticals U.S.A., Inc.
phone: 914 345 9001
e-mail: natalie.yantovskiy@taro.com


Publications of Results:

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00752973     History of Changes
Other Study ID Numbers: MALG-0813
First Submitted: September 15, 2008
First Posted: September 16, 2008
Results First Submitted: February 19, 2014
Results First Posted: April 3, 2014
Last Update Posted: August 7, 2014