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

Primary Purpose

Pediculosis

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Malathion gel 0.5%
Malathion lotion 0.5%
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediculosis focused on measuring Head Lice

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Malathion gel 0.05%

Malathion lotion 0.5%

Arm Description

Malathion gel 0.5% topical treatment for head lice

Malathion lotion 0.5% treatment for head lice

Outcomes

Primary Outcome Measures

Measurement of blood and urinary levels of malathion and metabolites

Secondary Outcome Measures

Measure cholinesterase levels and compare to malathion metabolite levels

Full Information

First Posted
June 23, 2009
Last Updated
December 21, 2013
Sponsor
Taro Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT00927407
Brief Title
Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice
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 Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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%.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediculosis
Keywords
Head Lice

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Malathion gel 0.05%
Arm Type
Experimental
Arm Description
Malathion gel 0.5% topical treatment for head lice
Arm Title
Malathion lotion 0.5%
Arm Type
Active Comparator
Arm Description
Malathion lotion 0.5% treatment for head lice
Intervention Type
Drug
Intervention Name(s)
Malathion gel 0.5%
Other Intervention Name(s)
MALG
Intervention Description
Malathion gel 0.5% applied to the scalp for 30 minutes
Intervention Type
Drug
Intervention Name(s)
Malathion lotion 0.5%
Other Intervention Name(s)
OVIDE lotion
Intervention Description
Malathion lotion 0.5% applied to scalp for 12 hours
Primary Outcome Measure Information:
Title
Measurement of blood and urinary levels of malathion and metabolites
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Measure cholinesterase levels and compare to malathion metabolite levels
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Investigator Site
City
Rabale
State/Province
Navi Mumbai
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
17845167
Citation
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.
Results Reference
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Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice

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