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Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

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ClinicalTrials.gov Identifier: NCT00963508
Recruitment Status : Completed
First Posted : August 21, 2009
Results First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

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 (Nix Crème)
Enrollment 403
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Malathion Gel Nix Crème Rinse
Hide Arm/Group Description

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 Crème Rinse applied to scalp for 10 minutes

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

Period Title: Overall Study
Started 206 197
Completed 196 169
Not Completed 10 28
Arm/Group Title Malathion Gel Nix Crème Rinse Total
Hide Arm/Group Description

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 Crème Rinse applied to scalp for 10 minutes

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

Total of all reporting groups
Overall Number of Baseline Participants 206 197 403
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 197 participants 403 participants
<=18 years
161
  78.2%
154
  78.2%
315
  78.2%
Between 18 and 65 years
45
  21.8%
42
  21.3%
87
  21.6%
>=65 years
0
   0.0%
1
   0.5%
1
   0.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 206 participants 197 participants 403 participants
13.45  (11.81) 13.85  (12.80) 13.66  (12.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 197 participants 403 participants
Female
181
  87.9%
168
  85.3%
349
  86.6%
Male
25
  12.1%
29
  14.7%
54
  13.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 206 participants 197 participants 403 participants
206 197 403
1.Primary Outcome
Title Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF)
Hide Description

The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7)

Treatment Success in the Efficacy ITT (LOCF)

index subjects: 150 from 403 randomized (the youngest subject in the household that met the index case criteria (having nits and at least 3 live lice))

Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy: index subjects who had at least one application of treatment mITT: treated subjects who had at least one post-treatment visit Subjects with missing efficacy data were included first LOCF and then with non-LOCF PP: subjects who complied with the protocol, completed all required visits Safety: all subjects who had at least one treatment
Arm/Group Title Malathion Gel Nix Crème Rinse
Hide Arm/Group Description:

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 Crème Rinse applied to scalp for 10 minutes

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

Overall Number of Participants Analyzed 75 75
Measure Type: Number
Unit of Measure: percentage of subjects
86.67 45.33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Malathion Gel, Nix Crème Rinse
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF).
Hide Description

The secondary efficacy variable was the proportion of subjects who were considered a Treatment Success 14 days after their first treatment.

Treatment Success in the Efficacy ITT (LOCF)

Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Proportion of subjects that are lice free 14 days after their first treatment
Arm/Group Title Malathion Gel Nix Crème Rinse
Hide Arm/Group Description:

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 Crème Rinse applied to scalp for 10 minutes

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

Overall Number of Participants Analyzed 198 184
Measure Type: Number
Unit of Measure: percentage of subjects
89.90 55.43
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Malathion Gel, Nix Crème Rinse
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Malathion Gel Nix Crème Rinse
Hide Arm/Group Description

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 Crème Rinse applied to scalp for 10 minutes

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

All-Cause Mortality
Malathion Gel Nix Crème Rinse
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Malathion Gel Nix Crème Rinse
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/206 (0.00%)      0/197 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Malathion Gel Nix Crème Rinse
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/206 (10.19%)      37/197 (18.78%)    
Eye disorders     
CONJUNCTIVAL IRRITATION  1  0/206 (0.00%)  0 3/197 (1.52%)  3
EYE IRRITATION  1  0/206 (0.00%)  0 1/197 (0.51%)  1
Gastrointestinal disorders     
VOMITING  1  1/206 (0.49%)  1 0/197 (0.00%)  0
General disorders     
INFLUENZA  1  1/206 (0.49%)  1 2/197 (1.02%)  2
Respiratory, thoracic and mediastinal disorders     
CHEST DISCOMFORT  1  0/206 (0.00%)  0 1/197 (0.51%)  1
Skin and subcutaneous tissue disorders     
APPLICATION SITE EROSION  1  1/206 (0.49%)  1 5/197 (2.54%)  5
APPLICATION SITE ERYTHEMA  1  10/206 (4.85%)  11 5/197 (2.54%)  5
APPLICATION SITE PRURITUS  1  4/206 (1.94%)  4 19/197 (9.64%)  19
APPLICATION SITE IRRITATION  1  4/206 (1.94%)  4 0/197 (0.00%)  0
RASH  1  0/206 (0.00%)  0 1/197 (0.51%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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
Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00963508     History of Changes
Other Study ID Numbers: MALG-0816
First Submitted: August 14, 2009
First Posted: August 21, 2009
Results First Submitted: January 31, 2014
Results First Posted: June 13, 2014
Last Update Posted: June 13, 2014