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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: 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):
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
Enrollment 254
Recruitment Details Subjects were recruited at 2 dermatology clinical practices
Pre-assignment Details  
Arm/Group Title Malathion Gel Nix Creme 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 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.

Period Title: Overall Study
Started 126 128
Completed 115 106
Not Completed 11 22
Reason Not Completed
Withdrawal by Subject             10             11
Lost to Follow-up             1             6
Protocol Violation             0             1
Post treatment Assessment out of window             0             4
Arm/Group Title Malathion Gel Nix Creme 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 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 of all reporting groups
Overall Number of Baseline Participants 126 128 254
Hide Baseline Analysis Population Description
Baseline characteristics were evaluated to identify differences between treatment groups which were not eliminated by randomization.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 126 participants 128 participants 254 participants
13.91  (11.79) 14.02  (11.88) 13.96  (11.68)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 128 participants 254 participants
<=18 years
95
  75.4%
97
  75.8%
192
  75.6%
Between 18 and 65 years
31
  24.6%
31
  24.2%
62
  24.4%
>=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 126 participants 128 participants 254 participants
Female
101
  80.2%
104
  81.3%
205
  80.7%
Male
25
  19.8%
24
  18.8%
49
  19.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 126 participants 128 participants 254 participants
126 128 254
1.Primary Outcome
Title Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment.
Hide Description

Treatment Success was evaluated using the Efficacy Intention to Treat (eITT) (LOCF) Efficacy ITT (eITT) was considered definitive.

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).

Index subject: 95 from 254 randomized (the youngest subject in the household who met index case criteria( having nits and at least 3 live lice))

Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

The Efficacy Intention to Treat (eITT) population was the primary population for demonstrating the superiority of the Malathion product to the active control Nix® Crème Rinse.

eITT population: included all index subjects with at least one application of treatment.

Proportion of Subjects that are lice-free 14 days after their last treatment

Arm/Group Title Malathion Gel Nix Creme 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 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.

Overall Number of Participants Analyzed 47 48
Measure Type: Number
Unit of Measure: percentage of subjects
82.98 62.50
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Malathion Gel, Nix Creme Rinse
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0386
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment
Hide Description

Treatment Success in the Efficacy Intention to Treat (eITT) (No LOCF)

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).

Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment Success in the Efficacy ITT (No LOCF) The Efficacy ITT population was the primary population for demonstrating the superiority of the Malathion product to the active control Nix® Crème Rinse.
Arm/Group Title Malathion Gel Nix Creme 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 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.

Overall Number of Participants Analyzed 47 48
Measure Type: Number
Unit of Measure: percentage of subjects
78.72 58.33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Malathion Gel, Nix Creme Rinse
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0490
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment
Hide Description

Treatment Success in the Per Protocol Population (PPP)

The PPP included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive.

Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-Protocol Population (PPP) included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive.
Arm/Group Title Malathion Gel Nix Creme 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 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.

Overall Number of Participants Analyzed 115 106
Measure Type: Number
Unit of Measure: percentage of subjects
91.30 71.70
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Malathion Gel, Nix Creme Rinse
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF)
Hide Description

Treatment Success in the Modified Intention to Treat (Modified ITT) (LOCF)

The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF

Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment Success in the Modified Intention to Treat ( Modified ITT) (LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF.
Arm/Group Title Malathion Gel Nix Creme 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 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.

Overall Number of Participants Analyzed 121 111
Measure Type: Number
Unit of Measure: percentage of subjects
91.74 72.97
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Malathion Gel, Nix Creme Rinse
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Primary Outcome
Title Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF).
Hide Description

Treatment Success in the Modified ITT (non-LOCF)

The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit.

Subjects with missing efficacy data were included first with LOCF and then with non-LOCF

Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment Success in the Modified ITT (LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF.
Arm/Group Title Malathion Gel Nix Creme 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 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.

Overall Number of Participants Analyzed 121 111
Measure Type: Number
Unit of Measure: percentage of subjects
86.78 68.47
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Malathion Gel, Nix Creme Rinse
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF))
Hide Description

Treatment Success in the Efficacy ITT (LOCF)

The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.

Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment Success in the Efficacy ITT (LOCF). The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment. Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 82; frequency missing = 13.
Arm/Group Title Malathion Gel Nix Creme 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 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.

Overall Number of Participants Analyzed 42 40
Measure Type: Number
Unit of Measure: percentage of subjects
80.95 70.00
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Malathion Gel, Nix Creme Rinse
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3675
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF))
Hide Description

Treatment Success in the Efficacy ITT (non LOCF)

The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.

Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Treatment Success was evaluated in the Efficacy ITT(non LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.

Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 82; frequency missing = 13.

Arm/Group Title Malathion Gel Nix Creme 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 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.

Overall Number of Participants Analyzed 42 40
Measure Type: Number
Unit of Measure: percentage of subjects
76.19 65.00
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Malathion Gel, Nix Creme Rinse
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3817
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP
Hide Description

Treatment Success in the PPP

The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.

The evaluations in the PPP was considered supportive.

Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

The evaluations in the PPP was considered supportive The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.

Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 188; frequency missing = 33.

Arm/Group Title Malathion Gel Nix Creme 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 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.

Overall Number of Participants Analyzed 104 84
Measure Type: Number
Unit of Measure: percentage of subjects
90.38 80.95
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Malathion Gel, Nix Creme Rinse
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1059
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF)
Hide Description

Treatment Success in the Modified ITT (LOCF)

The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.

The evaluations in the Modified ITT was considered supportive.

Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

The evaluations was in the Modified ITT was considered supportive. The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.

Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 199; frequency missing = 33.

Arm/Group Title Malathion Gel Nix Creme 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 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.

Overall Number of Participants Analyzed 110 89
Measure Type: Number
Unit of Measure: percentage of subjects
90.91 82.02
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Malathion Gel, Nix Creme Rinse
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1088
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF)
Hide Description

Treatment Success in the Modified ITT (non LOCF)

The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.

The evaluations in the Modified ITT was considered supportive.

Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

The evaluations in the Modified ITT was considered supportive. The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.

Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 199; frequency missing = 33.

Arm/Group Title Malathion Gel Nix Creme 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 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.

Overall Number of Participants Analyzed 110 89
Measure Type: Number
Unit of Measure: percentage of subjects
85.45 76.40
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Malathion Gel, Nix Creme Rinse
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1527
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Malathion Gel Nix Creme 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 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.

All-Cause Mortality
Malathion Gel Nix Creme Rinse
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Malathion Gel Nix Creme Rinse
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/126 (0.79%)      0/128 (0.00%)    
Eye disorders     
Conjunctival irritation * 1  1/126 (0.79%)  1 0/128 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.79%
Malathion Gel Nix Creme Rinse
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/126 (15.87%)      8/128 (6.25%)    
Eye disorders     
Conjunctival irritation * 1  1/126 (0.79%)  1 0/128 (0.00%)  0
Eye irritation * 1  3/126 (2.38%)  3 0/128 (0.00%)  0
Eye pain * 1  1/126 (0.79%)  1 0/128 (0.00%)  0
Gastrointestinal disorders     
Nausea * 1  1/126 (0.79%)  1 0/128 (0.00%)  0
Toothache * 1  0/126 (0.00%)  0 1/128 (0.78%)  1
General disorders     
Application site erythema * 1  1/126 (0.79%)  1 0/128 (0.00%)  0
Application site irritation * 1  6/126 (4.76%)  7 0/128 (0.00%)  0
Application site oedema * 1  1/126 (0.79%)  1 0/128 (0.00%)  0
Infections and infestations     
Otitis media * 1  0/126 (0.00%)  0 2/128 (1.56%)  2
Injury, poisoning and procedural complications     
Chemical eye injury * 1  1/126 (0.79%)  1 0/128 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Joint swelling * 1  1/126 (0.79%)  1 0/128 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/126 (0.79%)  1 0/128 (0.00%)  0
Skin and subcutaneous tissue disorders     
Erythema * 1  1/126 (0.79%)  1 0/128 (0.00%)  0
Pyoderma * 1  2/126 (1.59%)  2 0/128 (0.00%)  0
Scab * 1  0/126 (0.00%)  0 4/128 (3.13%)  4
Scratch * 1  0/126 (0.00%)  0 1/128 (0.78%)  1
*
Indicates events were collected by non-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.,
Phone: 914-345-9001
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