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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 Crème Rinse | Active Comparator | Nix Crème Rinse 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 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)) | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Hot Springs | Arkansas | United States | |||
| Investigator Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17845167 | Result | 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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| 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 Crème Rinse |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Permethrin 1% rinse (Nix Crème) | Drug | Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present. |
|
| Sacramento |
| California |
| United States |
| Investigator Site | Kissimmee | Florida | United States |
| Investigator Site | Miami | Florida | United States |
| Investigator Site | Ormond Beach | Florida | United States |
| Investigator Site | Picayune | Mississippi | United States |
| Investigator Site | San Antonio | Texas | United States |
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.
| COMPLETED |
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| NOT COMPLETED |
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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 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 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)) | 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 | Posted | Number | percentage of subjects | 3 weeks |
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| 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) | Proportion of subjects that are lice free 14 days after their first treatment | Posted | Number | percentage of subjects | 3 weeks |
|
|
7 months
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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. | 0 | 206 | 21 | 206 | ||
| EG001 | 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. | 0 | 197 | 37 | 197 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| APPLICATION SITE EROSION | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| APPLICATION SITE ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| APPLICATION SITE PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| APPLICATION SITE IRRITATION | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHEST DISCOMFORT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONJUNCTIVAL IRRITATION | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EYE IRRITATION | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| INFLUENZA | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Taro Pharmaceuticals U.S.A., Inc. | 914 -345-9001 | natalie.yantovskiy@taro.com |
| ID | Term |
|---|---|
| D010373 | Lice Infestations |
| ID | Term |
|---|---|
| D004478 | Ectoparasitic Infestations |
| D012876 | Skin Diseases, Parasitic |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D026023 | Permethrin |
| ID | Term |
|---|---|
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011722 | Pyrethrins |
| D000081004 | Cyclopentane Monoterpenes |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
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| >=65 years |
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| Male |
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