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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Malathion Gel | Experimental | Malathion gel 0.5% 30 minute application |
|
| Nix Creme Rinse | Active Comparator | Nix applied to scalp for 10 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Malathion gel 0.5% | Drug | Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)) | 3 weeks |
| 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). | 3 weeks |
| 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. | 3 weeks |
| 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 | 3 weeks |
| Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Bentonville | Arkansas | United States | |||
| Investigator Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17845167 | Background | Meinking TL, Vicaria M, Eyerdam DH, Villar ME, Reyna S, Suarez G. A randomized, investigator-blinded, time-ranging study of the comparative efficacy of 0.5% malathion gel versus Ovide Lotion (0.5% malathion) or Nix Creme Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol. 2007 Jul-Aug;24(4):405-11. doi: 10.1111/j.1525-1470.2007.00460.x. |
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Subjects were recruited at 2 dermatology clinical practices
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics were evaluated to identify differences between treatment groups which were not eliminated by randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Nix Creme Rinse |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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)) | 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 | Posted | Number | percentage of subjects | 3 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival irritation | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival irritation | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Taro Pharmaceuticals U.S.A., | 914-345-9001 | Natalie.Yantovskiy@Taro.com |
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| ID | Term |
|---|---|
| D010373 | Lice Infestations |
| ID | Term |
|---|---|
| D004478 | Ectoparasitic Infestations |
| D012876 | Skin Diseases, Parasitic |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D026023 | Permethrin |
| ID | Term |
|---|---|
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 |
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| Permethrin 1% rinse | Drug | Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present. |
|
|
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 |
| 3 weeks |
| 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. |
| 3 weeks |
| 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. | 3 weeks |
| 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. | 3 weeks |
| 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. | 3 weeks |
| Jonesboro |
| Arkansas |
| United States |
| Protocol Violation |
|
| Post treatment Assessment out of window |
|
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. |
| OG001 | 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. |
|
|
|
| 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. | 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. | Posted | Number | percentage of subjects | 3 weeks |
|
|
|
|
| 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). | 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. | Posted | Number | percentage of subjects | 3 weeks |
|
|
|
|
| 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. | 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. | Posted | Number | percentage of subjects | 3 weeks |
|
|
|
|
| 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 | 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. | Posted | Number | percentage of subjects | 3 weeks |
|
|
|
|
| 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 | 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. | Posted | Number | percentage of subjects | 3 weeks |
|
|
|
|
| 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. | 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. | Posted | Number | percentage of subjects | 3 weeks |
|
|
|
|
| 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. | 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. | Posted | Number | percentage of subjects | 3 weeks |
|
|
|
|
| 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. | 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. | Posted | Number | percentage of subjects | 3 weeks |
|
|
|
|
| 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. | 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. | Posted | Number | percentage of subjects | 3 weeks |
|
|
|
|
| 1 |
| 126 |
| 20 |
| 126 |
| EG001 | 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. | 0 | 128 | 8 | 128 |
| Eye irritation | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Application site erythema | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Application site irritation | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Application site oedema | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Chemical eye injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pyoderma | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Scratch | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
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| D012874 |
| Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011722 | Pyrethrins |
| D000081004 | Cyclopentane Monoterpenes |
| D039821 | Monoterpenes |
| D013729 | Terpenes |