Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice
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ClinicalTrials.gov Identifier: NCT00927407 |
Recruitment Status :
Completed
First Posted : June 25, 2009
Last Update Posted : December 24, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pediculosis | Drug: Malathion gel 0.5% Drug: Malathion lotion 0.5% | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Single-Dose, Parallel Group, Comparative Pharmacokinetic (PK) Study to Evaluate Malathion Gel 0.5% Versus Ovide (Malathion) Lotion 0.5% in Patients With Pediculosis Capitis |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | August 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Malathion gel 0.05%
Malathion gel 0.5% topical treatment for head lice
|
Drug: Malathion gel 0.5%
Malathion gel 0.5% applied to the scalp for 30 minutes
Other Name: MALG |
Active Comparator: Malathion lotion 0.5%
Malathion lotion 0.5% treatment for head lice
|
Drug: Malathion lotion 0.5%
Malathion lotion 0.5% applied to scalp for 12 hours
Other Name: OVIDE lotion |
- Measurement of blood and urinary levels of malathion and metabolites [ Time Frame: 48 hours ]
- Measure cholinesterase levels and compare to malathion metabolite levels [ Time Frame: 48 hours ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or non-pregnant female
- Patients 18 years of age or older and healthy presenting with Pediculosis capitis
- The Patient must be willing to consent to the Patient's treatment with Malathion Gel 0.5% or Ovide Lotion 0.5% and for blood drawings before and after medication administration.
Exclusion Criteria:
- Individuals with history of irritation or sensitivity to pediculicides or hair care products
- Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, or Sponsor, will interfere with the evaluation.
- Individuals previously treated with a pediculicide within 4 weeks of the study.
- Individuals who exhibit potential signs and symptoms of cholinesterase inhibition.
- Patients currently receiving sulfonamide antibiotics or ivermectin.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927407
India | |
Investigator Site | |
Rabale, Navi Mumbai, India |
Publications:
Responsible Party: | Taro Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00927407 History of Changes |
Other Study ID Numbers: |
MALG-0603 |
First Posted: | June 25, 2009 Key Record Dates |
Last Update Posted: | December 24, 2013 |
Last Verified: | December 2013 |
Keywords provided by Taro Pharmaceuticals USA:
Head Lice |
Additional relevant MeSH terms:
Lice Infestations Ectoparasitic Infestations Skin Diseases, Parasitic Parasitic Diseases Skin Diseases, Infectious Skin Diseases Malathion |
Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs |