Expired Study
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Jonesboro, Arkansas


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.


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

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

Phase II, Multi-Center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis

Overall Status:


Study Phase:

Phase 2/Phase 3



Minimum Age:

6 Months

Maximum Age:

24 Months

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Taro Pharmaceuticals USA

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Non-Randomized, Endpoint Classificatio

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Study Dates

Start Date:September 2008
Completion Date:January 2012
Completion Type:Actual
Primary Completion Date:December 2011
Primary Completion Type:Actual
Verification Date:November 2013
Last Changed Date:December 19, 2013
First Received Date:September 15, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Cure of head lice 14 days after last treatment
Time Frame:2-3 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Local tolerability
Time Frame:2-3 weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Clinical evidence of cholinesterase inhibition
Time Frame:1 day
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Change in cholinesterase level
Time Frame:1 day
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:MALG (malathion) Treatment
Description:MALG applied for 30 minutes
Arm Name:Treatment arm
Other Name:Novel malathion formulation

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment arm
Description:MALG treatment

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Taro Pharmaceuticals USA

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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 Crème Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol. 2007 Jul-Aug;24(4):405-11.

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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