Pediculosis
Conditions
Keywords
Head Lice
Brief summary
In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.
Detailed description
This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pharmaceuticals.
Interventions
Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.
DRUGPermethrin 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.
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed active head lice infestation
Exclusion criteria
* Allergy to pediculicides or hair care products * Scalp conditions other than head lice * Previous head lice treatment within the past 4 weeks * Current antibiotic treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF) | 3 weeks | 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)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF). | 3 weeks | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 206 |
| 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. | 197 |
| Total | 403 |
Baseline characteristics
| Characteristic | Nix Crème Rinse | Malathion Gel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 154 Participants | 161 Participants | 315 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants | 45 Participants | 87 Participants |
| Age, Continuous | 13.85 years STANDARD_DEVIATION 12.8 | 13.45 years STANDARD_DEVIATION 11.81 | 13.66 years STANDARD_DEVIATION 12.3 |
| Region of Enrollment United States | 197 participants | 206 participants | 403 participants |
| Sex: Female, Male Female | 168 Participants | 181 Participants | 349 Participants |
| Sex: Female, Male Male | 29 Participants | 25 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 206 | 37 / 197 |
| serious Total, serious adverse events | 0 / 206 | 0 / 197 |
Outcome results
Primary
Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (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) 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
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Malathion Gel | Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF) | 86.67 percentage of subjects |
| Nix Crème Rinse | Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF) | 45.33 percentage of subjects |
p-value: <0.0001t-test, 2 sided
Secondary
Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF).
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
Population: Proportion of subjects that are lice free 14 days after their first treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Malathion Gel | 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 |
| Nix Crème Rinse | Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF). | 55.43 percentage of subjects |
p-value: 0.0005t-test, 2 sided