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

NCT ID: NCT00927407

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-08-31

Brief Summary

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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

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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.

Conditions

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Pediculosis

Keywords

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Head Lice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Malathion gel 0.05%

Malathion gel 0.5% topical treatment for head lice

Group Type EXPERIMENTAL

Malathion gel 0.5%

Intervention Type DRUG

Malathion gel 0.5% applied to the scalp for 30 minutes

Malathion lotion 0.5%

Malathion lotion 0.5% treatment for head lice

Group Type ACTIVE_COMPARATOR

Malathion lotion 0.5%

Intervention Type DRUG

Malathion lotion 0.5% applied to scalp for 12 hours

Interventions

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Malathion gel 0.5%

Malathion gel 0.5% applied to the scalp for 30 minutes

Intervention Type DRUG

Malathion lotion 0.5%

Malathion lotion 0.5% applied to scalp for 12 hours

Intervention Type DRUG

Other Intervention Names

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MALG OVIDE lotion

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigator Site

Rabale, Navi Mumbai, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 17845167 (View on PubMed)

Other Identifiers

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MALG-0603

Identifier Type: -

Identifier Source: org_study_id