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
Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if 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 All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF). | 3 weeks | 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 |
| Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment. | 3 weeks | 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)) |
| Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment | 3 weeks | 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). |
| Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment | 3 weeks | 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. |
| Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF) | 3 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF)) | 3 weeks | 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. |
| Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF)) | 3 weeks | 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. |
| Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP | 3 weeks | 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. |
| Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF) | 3 weeks | 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. |
| Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF) | 3 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited at 2 dermatology clinical practices
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. | 126 |
| 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. | 128 |
| Total | 254 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 6 |
| Overall Study | Post treatment Assessment out of window | 0 | 4 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 10 | 11 |
Baseline characteristics
| Characteristic | Malathion Gel | Nix Creme Rinse | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 95 Participants | 97 Participants | 192 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 31 Participants | 62 Participants |
| Age, Continuous | 13.91 years STANDARD_DEVIATION 11.79 | 14.02 years STANDARD_DEVIATION 11.88 | 13.96 years STANDARD_DEVIATION 11.68 |
| Region of Enrollment United States | 126 participants | 128 participants | 254 participants |
| Sex: Female, Male Female | 101 Participants | 104 Participants | 205 Participants |
| Sex: Female, Male Male | 25 Participants | 24 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 126 | 8 / 128 |
| serious Total, serious adverse events | 1 / 126 | 0 / 128 |
Outcome results
Primary
Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(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
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Malathion Gel | Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF) | 91.74 percentage of subjects |
| Nix Creme Rinse | Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF) | 72.97 percentage of subjects |
p-value: 0.0003t-test, 2 sided
Primary
Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (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
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Malathion Gel | Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF). | 86.78 percentage of subjects |
| Nix Creme Rinse | Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF). | 68.47 percentage of subjects |
p-value: 0.0012t-test, 2 sided
Primary
Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment.
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
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
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Malathion Gel | Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment. | 82.98 percentage of subjects | 3.25 |
| Nix Creme Rinse | Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment. | 62.50 percentage of subjects | 4.95 |
p-value: 0.0386t-test, 2 sided
Primary
Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Malathion Gel | Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment | 91.30 percentage of subjects |
| Nix Creme Rinse | Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment | 71.70 percentage of subjects |
p-value: 0.0002t-test, 2 sided
Primary
Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Malathion Gel | Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment | 78.72 percentage of subjects |
| Nix Creme Rinse | Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment | 58.33 percentage of subjects |
p-value: 0.049t-test, 2 sided
Secondary
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF))
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Malathion Gel | Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF)) | 80.95 percentage of subjects |
| Nix Creme Rinse | Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF)) | 70.00 percentage of subjects |
p-value: 0.3675t-test, 2 sided
Secondary
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF))
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Malathion Gel | 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 |
| Nix Creme Rinse | Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF)) | 65.00 percentage of subjects |
p-value: 0.3817t-test, 2 sided
Secondary
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF)
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Malathion Gel | Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF) | 90.91 percentage of subjects |
| Nix Creme Rinse | Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF) | 82.02 percentage of subjects |
p-value: 0.1088t-test, 2 sided
Secondary
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF)
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Malathion Gel | 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 |
| Nix Creme Rinse | Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF) | 76.40 percentage of subjects |
p-value: 0.1527t-test, 2 sided
Secondary
Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Malathion Gel | Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP | 90.38 percentage of subjects |
| Nix Creme Rinse | Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP | 80.95 percentage of subjects |
p-value: 0.1059t-test, 2 sided