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

Sponsored by:	Taro Pharmaceuticals USA
Information provided by:	Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:	NCT00752973

Purpose

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.

Condition	Intervention	Phase
Pediculosis	Drug: MALG (malathion) Treatment	Phase II Phase III

Drug Information available for: Malathion

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II, Multi-Center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis

Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:

Change in cholinesterase level [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical evidence of cholinesterase inhibition [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Local tolerability [ Time Frame: 2-3 weeks ] [ Designated as safety issue: Yes ]
Cure of head lice 14 days after last treatment [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment arm: Experimental MALG treatment	Drug: MALG (malathion) Treatment MALG applied for 30 minutes

Eligibility

Ages Eligible for Study:	6 Months to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752973

Contacts

Contact: Medical Affairs Taro Pharmaceuticals

(914) 345-9001 ext 6427

medical.affairs@taro.com

Locations

United States, Arkansas
Harvey Pediatrics, PLLC	Recruiting
Jonesboro, Arkansas, United States, 72401
Contact: Tonya Hogue 870-931-0300 ext 1 thogue0301@yahoo.com
Principal Investigator: Bryan Harvey, MD
Children's Investigational Research Program, LLC (CHIRP)	Recruiting
Bentonville, Arkansas, United States, 72712
Contact: Misty Ross 479-254-6772 mistyross.chirp@yahoo.com
Principal Investigator: Jason Foster, MD

Sponsors and Collaborators

Taro Pharmaceuticals USA

Investigators

Principal Investigator:

Bryan Harvey, MD

Harvey Pediatrics, PLLC

More Information

Publications of Results:

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.

Responsible Party:	Taro Pharmaceuticals USA ( Medical Director )
Study ID Numbers:	MALG-0813
Study First Received:	September 15, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00752973
Health Authority:	United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:

Head Lice

Study placed in the following topic categories:

Lice Infestations
Skin Diseases, Infectious
Skin Diseases
Parasitic Diseases
Malathion

Additional relevant MeSH terms:

Cholinesterase Inhibitors
Ectoparasitic Infestations
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Skin Diseases, Parasitic

Physiological Effects of Drugs
Enzyme Inhibitors
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009