Trial Outcomes & Findings for Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice (NCT NCT00927472)

Last Updated: 2014-08-04

Results Overview

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))

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

254 participants

Primary outcome timeframe

3 weeks

Results posted on

2014-08-04

Participant Flow

Subjects were recruited at 2 dermatology clinical practices

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 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.
Overall Study STARTED	126	128
Overall Study COMPLETED	115	106
Overall Study NOT COMPLETED	11	22

Reasons for withdrawal

Reasons for withdrawal
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 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.
Overall Study Withdrawal by Subject	10	11
Overall Study Lost to Follow-up	1	6
Overall Study Protocol Violation	0	1
Overall Study Post treatment Assessment out of window	0	4

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=126 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 Creme Rinse n=128 Participants 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 n=254 Participants Total of all reporting groups
Age, Continuous	13.91 years STANDARD_DEVIATION 11.79 • n=5 Participants	14.02 years STANDARD_DEVIATION 11.88 • n=7 Participants	13.96 years STANDARD_DEVIATION 11.68 • n=5 Participants
Age, Categorical <=18 years	95 Participants n=5 Participants	97 Participants n=7 Participants	192 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	104 Participants n=7 Participants	205 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Region of Enrollment United States	126 participants n=5 Participants	128 participants n=7 Participants	254 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Population: 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

Outcome measures

Outcome measures
Measure	Malathion Gel n=47 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 Creme Rinse n=48 Participants 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.
Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment.	82.98 percentage of subjects 3.25	62.50 percentage of subjects 4.95

PRIMARY outcome

Timeframe: 3 weeks

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Malathion Gel n=47 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 Creme Rinse n=48 Participants 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.
Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment	78.72 percentage of subjects	58.33 percentage of subjects

PRIMARY outcome

Timeframe: 3 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Malathion Gel n=115 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 Creme Rinse n=106 Participants 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.
Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment	91.30 percentage of subjects	71.70 percentage of subjects

PRIMARY outcome

Timeframe: 3 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	Malathion Gel n=121 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 Creme Rinse n=111 Participants 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.
Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF)	91.74 percentage of subjects	72.97 percentage of subjects

PRIMARY outcome

Timeframe: 3 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	Malathion Gel n=121 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 Creme Rinse n=111 Participants 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.
Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF).	86.78 percentage of subjects	68.47 percentage of subjects

SECONDARY outcome

Timeframe: 3 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Malathion Gel n=42 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 Creme Rinse n=40 Participants 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.
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF))	80.95 percentage of subjects	70.00 percentage of subjects

SECONDARY outcome

Timeframe: 3 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Malathion Gel n=42 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 Creme Rinse n=40 Participants 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.
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF))	76.19 percentage of subjects	65.00 percentage of subjects

SECONDARY outcome

Timeframe: 3 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Malathion Gel n=104 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 Creme Rinse n=84 Participants 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.
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP	90.38 percentage of subjects	80.95 percentage of subjects

SECONDARY outcome

Timeframe: 3 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Malathion Gel n=110 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 Creme Rinse n=89 Participants 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.
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF)	90.91 percentage of subjects	82.02 percentage of subjects

SECONDARY outcome

Timeframe: 3 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Malathion Gel n=110 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 Creme Rinse n=89 Participants 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.
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF)	85.45 percentage of subjects	76.40 percentage of subjects

Adverse Events

Malathion Gel

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Nix Creme Rinse

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Malathion Gel n=126 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 Creme Rinse n=128 participants at risk 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.
Eye disorders Conjunctival irritation	0.79% 1/126 • Number of events 1	0.00% 0/128

Other adverse events

Other adverse events
Measure	Malathion Gel n=126 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 Creme Rinse n=128 participants at risk 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.
Eye disorders Conjunctival irritation	0.79% 1/126 • Number of events 1	0.00% 0/128
Eye disorders Eye irritation	2.4% 3/126 • Number of events 3	0.00% 0/128
Eye disorders Eye pain	0.79% 1/126 • Number of events 1	0.00% 0/128
Gastrointestinal disorders Nausea	0.79% 1/126 • Number of events 1	0.00% 0/128
Gastrointestinal disorders Toothache	0.00% 0/126	0.78% 1/128 • Number of events 1
General disorders Application site erythema	0.79% 1/126 • Number of events 1	0.00% 0/128
General disorders Application site irritation	4.8% 6/126 • Number of events 7	0.00% 0/128
General disorders Application site oedema	0.79% 1/126 • Number of events 1	0.00% 0/128
Infections and infestations Otitis media	0.00% 0/126	1.6% 2/128 • Number of events 2
Injury, poisoning and procedural complications Chemical eye injury	0.79% 1/126 • Number of events 1	0.00% 0/128
Musculoskeletal and connective tissue disorders Joint swelling	0.79% 1/126 • Number of events 1	0.00% 0/128
Respiratory, thoracic and mediastinal disorders Asthma	0.79% 1/126 • Number of events 1	0.00% 0/128
Skin and subcutaneous tissue disorders Erythema	0.79% 1/126 • Number of events 1	0.00% 0/128
Skin and subcutaneous tissue disorders Pyoderma	1.6% 2/126 • Number of events 2	0.00% 0/128
Skin and subcutaneous tissue disorders Scab	0.00% 0/126	3.1% 4/128 • Number of events 4
Skin and subcutaneous tissue disorders Scratch	0.00% 0/126	0.78% 1/128 • Number of events 1

Additional Information

Director, Clinical Research

Taro Pharmaceuticals U.S.A.,

Phone: 914-345-9001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place