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In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population.
The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | MALG treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MALG (malathion) Treatment | Drug | MALG applied for 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With a Change in Cholinesterase Level at 1 Hour (Day 0). | Each patient (aged 6 - 24 months) was assessed at 1 hour (Day 0). The mean percent change (reduction) in plasma and RBC cholinesterase activity from baseline to 1 hr after application was calculated and accompanied by 95% confidence intervals. If the half-widths of the derived confidence intervals are sufficiently narrow, it will demonstrate that any observed reductions in plasma and RBC cholinesterase activity fall within established safety guidelines. Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment. Mean percent change (reduction) = (Post treatment value - Baseline)/ Baseline x100. | Change from Baseline to 1 hour |
| Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day). | Each patient was assessed at Day 1 and the mean percent reduction in plasma and RBC cholinesterase activity from baseline to 24 hr after application was calculated and accompanied by 95% confidence intervals. Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment. Mean percent reduction = (Post treatment value - Baseline)/ Baseline x100. | Change from baseline to 24 hrs (1 day) |
| Participants With the Clinical Evidence of Cholinesterase Inhibition | Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition.
One participant had wheezing as medical history which continued without increase in severity throughout the treatment. | at Baseline |
| Participants With the Clinical Evidence of Cholinesterase Inhibition |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions. | To evaluate the safety of Malathion Gel, 0.5% based upon reported adverse events and observed scalp reactions. Additional safety assessments included eye Irritation. | Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments) |
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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 | 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 0.5% Treatment Arm | Malathion Gel 0.5% treatment MALG (Malathion Gel 0.5%) Treatment: MALG applied for 30 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MALG Treatment Arm | MALG treatment MALG (malathion) Treatment: MALG applied for 30 minutes |
| 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 | Participants With a Change in Cholinesterase Level at 1 Hour (Day 0). | Each patient (aged 6 - 24 months) was assessed at 1 hour (Day 0). The mean percent change (reduction) in plasma and RBC cholinesterase activity from baseline to 1 hr after application was calculated and accompanied by 95% confidence intervals. If the half-widths of the derived confidence intervals are sufficiently narrow, it will demonstrate that any observed reductions in plasma and RBC cholinesterase activity fall within established safety guidelines. Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment. Mean percent change (reduction) = (Post treatment value - Baseline)/ Baseline x100. | 10 subjects with obtained blood sample. subject 01-003: Study coordinator was unable to obtain blood sample post treatment at Visit 1, Day 0. subject 01-004: At Visit 1 Day 0 (post treatment), Blood sample could not be obtained even after two attempts. | Posted | Mean | 95% Confidence Interval | percentage change in cholinesterase | Change from Baseline to 1 hour |
|
22 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 | MALG Treatment Arm | MALG treatment MALG (malathion) Treatment: MALG applied for 30 minutes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal 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 |
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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 |
|---|---|
| D008294 | Malathion |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D063086 | Organothiophosphates |
| D010755 | Organophosphates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence cholinesterase inhibition :
One participants had wheezing as medical history which continued without increase in severity throughout the treatment.
| at 1 hr (Day 0) |
| Participants With the Clinical Evidence of Cholinesterase Inhibition | Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition :
One participants had wheezing as medical history which continued without increase in severity throughout the treatment. | at 24 hrs (Day 1) |
| Participants Clinically Cured of Head Lice 14 Days After Last Treatment | No live lice (including adults and nymphs) and nits at Day 7±1 and final lice assessment on either Day 14 (subjects not requiring retreatment) or Day 21 (for retreated subjects). | Day 7±1 and Day 14 or Day 21 |
| Jonesboro |
| Arkansas |
| United States |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | MALG (Malathion Gel, 0.5% )Treatment Arm | MALG (Malathion Gel, 0.5% ) treatment MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes Two subjects had out of range RBC cholinesterase values. One subject had out of range (low) value at baseline and One subject had out of range (low) value 1 h post treatment. Both these values were considered to be not clinically significant by the investigator. |
|
|
| Primary | Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day). | Each patient was assessed at Day 1 and the mean percent reduction in plasma and RBC cholinesterase activity from baseline to 24 hr after application was calculated and accompanied by 95% confidence intervals. Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment. Mean percent reduction = (Post treatment value - Baseline)/ Baseline x100. | 11 subjects with obtained blood sample. subject 01-004: At Visit 2, Day 1 Lab could not perform testing due to sample not suitable for testing. Because only 2ml blood was able to collected after multiple attempts. | Posted | Mean | 95% Confidence Interval | percentage change in cholinesterase | Change from baseline to 24 hrs (1 day) |
|
|
|
| Primary | Participants With the Clinical Evidence of Cholinesterase Inhibition | Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition.
One participant had wheezing as medical history which continued without increase in severity throughout the treatment. | Posted | Number | percentage of participants | at Baseline |
|
|
|
| Primary | Participants With the Clinical Evidence of Cholinesterase Inhibition | Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence cholinesterase inhibition :
One participants had wheezing as medical history which continued without increase in severity throughout the treatment. | Posted | Number | percentage of participants | at 1 hr (Day 0) |
|
|
|
| Primary | Participants With the Clinical Evidence of Cholinesterase Inhibition | Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition :
One participants had wheezing as medical history which continued without increase in severity throughout the treatment. | Posted | Number | percentage of participants | at 24 hrs (Day 1) |
|
|
|
| Primary | Participants Clinically Cured of Head Lice 14 Days After Last Treatment | No live lice (including adults and nymphs) and nits at Day 7±1 and final lice assessment on either Day 14 (subjects not requiring retreatment) or Day 21 (for retreated subjects). | No statistical analysis provided for Clinical Cure | Posted | Number | participants cured of lice | Day 7±1 and Day 14 or Day 21 |
|
|
|
| Secondary | Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions. | To evaluate the safety of Malathion Gel, 0.5% based upon reported adverse events and observed scalp reactions. Additional safety assessments included eye Irritation. | A total of 12 subjects were enrolled. All of them used the study drug for at least one dose of the treatment. At Day 0 the study drug was to be used. At Day 7 if subject presented with live lice they were provided a second treatment. The subjects may used it for 1 (for subjects not requiring retreatment) or 2 (for retreated subjects). | Posted | Number | participants | Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments) |
|
|
|
| 0 |
| 12 |
| 3 |
| 12 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0). | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 10.0). | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D012874 |
| Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009946 |
| Organothiophosphorus Compounds |
| D013457 | Sulfur Compounds |
| Title | Measurements |
|---|---|
|