Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice

NCT ID: NCT00752973

Last Updated: 2014-08-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pediculosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm

MALG treatment

Group Type EXPERIMENTAL

MALG (malathion) Treatment

Intervention Type DRUG

MALG applied for 30 minutes

Interventions

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MALG (malathion) Treatment

MALG applied for 30 minutes

Intervention Type DRUG

Other Intervention Names

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Novel malathion formulation

Eligibility Criteria

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Inclusion Criteria

* Confirmed active head lice infestation

Exclusion Criteria

* Allergy to pediculicides or hair care products
* Scalp conditions other than head lice
* Previous head lice treatment within the past 4 weeks
* Current antibiotic treatment
Minimum Eligible Age

6 Months

Maximum Eligible Age

24 Months

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

Bentonville, Arkansas, United States

Site Status

Investigator Site

Jonesboro, Arkansas, United States

Site Status

Countries

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United States

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 RESULT
PMID: 17845167 (View on PubMed)

Other Identifiers

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MALG-0813

Identifier Type: -

Identifier Source: org_study_id

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