Trial Outcomes & Findings for Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice (NCT NCT00963508)

Last Updated: 2014-06-13

Results Overview

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))

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

403 participants

Primary outcome timeframe

3 weeks

Results posted on

2014-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	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 Crème Rinse 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 Study STARTED	206	197
Overall Study COMPLETED	196	169
Overall Study NOT COMPLETED	10	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Malathion Gel n=206 Participants 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 n=197 Participants 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 n=403 Participants Total of all reporting groups
Age, Categorical <=18 years	161 Participants n=5 Participants	154 Participants n=7 Participants	315 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	42 Participants n=7 Participants	87 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	13.45 years STANDARD_DEVIATION 11.81 • n=5 Participants	13.85 years STANDARD_DEVIATION 12.80 • n=7 Participants	13.66 years STANDARD_DEVIATION 12.30 • n=5 Participants
Sex: Female, Male Female	181 Participants n=5 Participants	168 Participants n=7 Participants	349 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Region of Enrollment United States	206 participants n=5 Participants	197 participants n=7 Participants	403 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Population: 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

Outcome measures

Outcome measures
Measure	Malathion Gel n=75 Participants 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 n=75 Participants 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.
Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF)	86.67 percentage of subjects	45.33 percentage of subjects

SECONDARY outcome

Timeframe: 3 weeks

Population: Proportion of subjects that are lice free 14 days after their first treatment

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)

Outcome measures

Outcome measures
Measure	Malathion Gel n=198 Participants 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 n=184 Participants 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.
Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF).	89.90 percentage of subjects	55.43 percentage of subjects

Adverse Events

Malathion Gel

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Nix Crème Rinse

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Malathion Gel n=206 participants at risk 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 n=197 participants at risk 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.
Skin and subcutaneous tissue disorders APPLICATION SITE EROSION	0.49% 1/206 • Number of events 1 • 7 months	2.5% 5/197 • Number of events 5 • 7 months
Skin and subcutaneous tissue disorders APPLICATION SITE ERYTHEMA	4.9% 10/206 • Number of events 11 • 7 months	2.5% 5/197 • Number of events 5 • 7 months
Skin and subcutaneous tissue disorders APPLICATION SITE PRURITUS	1.9% 4/206 • Number of events 4 • 7 months	9.6% 19/197 • Number of events 19 • 7 months
Skin and subcutaneous tissue disorders APPLICATION SITE IRRITATION	1.9% 4/206 • Number of events 4 • 7 months	0.00% 0/197 • 7 months
Respiratory, thoracic and mediastinal disorders CHEST DISCOMFORT	0.00% 0/206 • 7 months	0.51% 1/197 • Number of events 1 • 7 months
Eye disorders CONJUNCTIVAL IRRITATION	0.00% 0/206 • 7 months	1.5% 3/197 • Number of events 3 • 7 months
Eye disorders EYE IRRITATION	0.00% 0/206 • 7 months	0.51% 1/197 • Number of events 1 • 7 months
General disorders INFLUENZA	0.49% 1/206 • Number of events 1 • 7 months	1.0% 2/197 • Number of events 2 • 7 months
Skin and subcutaneous tissue disorders RASH	0.00% 0/206 • 7 months	0.51% 1/197 • Number of events 1 • 7 months
Gastrointestinal disorders VOMITING	0.49% 1/206 • Number of events 1 • 7 months	0.00% 0/197 • 7 months

Additional Information

Director, Clinical Research

Taro Pharmaceuticals U.S.A., Inc.

Phone: 914 -345-9001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place