CLINICAL TRIALS PROFILE FOR MALATHION
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505(b)(2) Clinical Trials for MALATHION
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT00244439 ↗ | Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice | Completed | Taro Pharmaceuticals USA | Phase 3 | 2005-12-01 | Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product. |
| New Formulation | NCT00927472 ↗ | Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice | Completed | Taro Pharmaceuticals USA | Phase 3 | 2009-08-01 | 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. |
| New Formulation | NCT00963508 ↗ | Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice | Completed | Taro Pharmaceuticals USA | Phase 3 | 2009-08-01 | 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. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for MALATHION
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00244439 ↗ | Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice | Completed | Taro Pharmaceuticals USA | Phase 3 | 2005-12-01 | Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product. |
| NCT00291057 ↗ | Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice | Terminated | Taro Pharmaceuticals USA | Phase 2 | 2006-02-01 | 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. |
| NCT00752973 ↗ | Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice | Completed | Taro Pharmaceuticals USA | Phase 2/Phase 3 | 2008-09-01 | 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. |
| NCT00819520 ↗ | Ivermectin in the Treatment of Head Lice | Completed | Johnson & Johnson Consumer and Personal Products Worldwide | Phase 3 | 2004-02-01 | The purpose of this study is to compare 2 single doses of ivermectin as tablets with 2 single applications of malathion 0.5% lotion (Days 1 and 8) in clearing head lice, in patients who have recently used standard head lice treatments without success. |
| NCT00927407 ↗ | Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice | Completed | Taro Pharmaceuticals USA | Phase 1 | 2009-07-01 | In this study, 24 adult patients with head lice will be treated with a topical malathion head lice treatment; 12 patients will be treated with a novel product, Malathion Gel, 0.5%, and other 12 patients will be treated with Ovide Lotion 0.5% marketed by Taro Pharmaceuticals USA, Inc. The primary objective of this study is to compare the blood level exposure of Malathion 0.5% Gel to that of the OVIDE Lotion 0.5%. |
| NCT00927472 ↗ | Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice | Completed | Taro Pharmaceuticals USA | Phase 3 | 2009-08-01 | 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. |
| NCT00963508 ↗ | Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice | Completed | Taro Pharmaceuticals USA | Phase 3 | 2009-08-01 | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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