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Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older 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: NCT00927472
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pediculosis
Interventions: Drug: Malathion gel 0.5%
Drug: Permethrin 1% rinse

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited at 2 dermatology clinical practices

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

Malathion gel 0.5% 30 minute application

Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.

Nix Creme Rinse

Nix applied to scalp for 10 minutes

Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.


Participant Flow:   Overall Study
    Malathion Gel   Nix Creme Rinse
STARTED   126   128 
COMPLETED   115   106 
NOT COMPLETED   11   22 
Withdrawal by Subject                10                11 
Lost to Follow-up                1                6 
Protocol Violation                0                1 
Post treatment Assessment out of window                0                4 



  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.
Baseline characteristics were evaluated to identify differences between treatment groups which were not eliminated by randomization.

Reporting Groups
  Description
Malathion Gel

Malathion gel 0.5% 30 minute application

Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.

Nix Creme Rinse

Nix applied to scalp for 10 minutes

Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.

Total Total of all reporting groups

Baseline Measures
   Malathion Gel   Nix Creme Rinse   Total 
Overall Participants Analyzed 
[Units: Participants]
 126   128   254 
Age 
[Units: Years]
Mean (Standard Deviation)
 13.91  (11.79)   14.02  (11.88)   13.96  (11.68) 
Age 
[Units: Participants]
     
<=18 years   95   97   192 
Between 18 and 65 years   31   31   62 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   101   104   205 
Male   25   24   49 
Region of Enrollment 
[Units: Participants]
     
United States   126   128   254 


  Outcome Measures

1.  Primary:   Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment.   [ Time Frame: 3 weeks ]

2.  Primary:   Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment   [ Time Frame: 3 weeks ]

3.  Primary:   Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment   [ Time Frame: 3 weeks ]

4.  Primary:   Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF)   [ Time Frame: 3 weeks ]

5.  Primary:   Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF).   [ Time Frame: 3 weeks ]

6.  Secondary:   Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF))   [ Time Frame: 3 weeks ]

7.  Secondary:   Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF))   [ Time Frame: 3 weeks ]

8.  Secondary:   Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP   [ Time Frame: 3 weeks ]

9.  Secondary:   Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF)   [ Time Frame: 3 weeks ]

10.  Secondary:   Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF)   [ Time Frame: 3 weeks ]


  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:  
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.,
phone: 914-345-9001
e-mail: Natalie.Yantovskiy@Taro.com


Publications:

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00927472     History of Changes
Other Study ID Numbers: MALG-0817
First Submitted: June 23, 2009
First Posted: June 25, 2009
Results First Submitted: January 17, 2014
Results First Posted: August 4, 2014
Last Update Posted: August 4, 2014