Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice

Overview

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%.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2009

Detailed Description

A randomized, single-dose, parallel group, comparative PK study. Patients will be randomly assigned in 1:1 ratio to the study products. Twenty four (24) consenting patients, age 18 years and older, who meet Inclusion/Exclusion criteria will be enrolled in this study. 12 Patients will be treated with Malathion Gel, 0.5% and other 12 Patients will be treated with Ovide Lotion 0.5%. The study will be single centre and conducted only in India. The primary objective of this study is to compare the systemic exposure of Malathion 0.5% Gel manufactured by Taro Pharmaceuticals USA, Inc. to that of the OVIDE Lotion 0.5%, currently marketed by Taro Pharmaceutical USA, Inc., in adult Patients with head lice. The secondary objective is to determine the link between the exposure and cholinesterase activity.

Interventions

  • Drug: Malathion gel 0.5%
    • Malathion gel 0.5% applied to the scalp for 30 minutes
  • Drug: Malathion lotion 0.5%
    • Malathion lotion 0.5% applied to scalp for 12 hours

Arms, Groups and Cohorts

  • Experimental: Malathion gel 0.05%
    • Malathion gel 0.5% topical treatment for head lice
  • Active Comparator: Malathion lotion 0.5%
    • Malathion lotion 0.5% treatment for head lice

Clinical Trial Outcome Measures

Primary Measures

  • Measurement of blood and urinary levels of malathion and metabolites
    • Time Frame: 48 hours

Secondary Measures

  • Measure cholinesterase levels and compare to malathion metabolite levels
    • Time Frame: 48 hours

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Taro Pharmaceuticals USA
  • Provider of Information About this Clinical Study
    • Sponsor

References

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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