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

NCT00927407 | Completed Phase 1

• 1 other identifier: MALG-0603
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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%.

Conditions

Pediculosis

Keywords

Head Lice

Outcome Measures

Primary Outcomes (1)

• Measurement of blood and urinary levels of malathion and metabolites

  48 hours

Secondary Outcomes (1)

• Measure cholinesterase levels and compare to malathion metabolite levels

  48 hours

Study Arms (2)

Malathion gel 0.05%

EXPERIMENTAL

Malathion gel 0.5% topical treatment for head lice

Drug: Malathion gel 0.5%

Malathion lotion 0.5%

ACTIVE COMPARATOR

Malathion lotion 0.5% treatment for head lice

Drug: Malathion lotion 0.5%

Interventions

Malathion gel 0.5% DRUG

Malathion gel 0.5% applied to the scalp for 30 minutes

Also known as: MALG

Malathion gel 0.05%

Malathion lotion 0.5% DRUG

Malathion lotion 0.5% applied to scalp for 12 hours

Also known as: OVIDE lotion

Malathion lotion 0.5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Investigator Site

Rabale, Navi Mumbai, India

Location

Related Publications (1)

• 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.

  PMID: 17845167 BACKGROUND

MeSH Terms

Conditions

Lice Infestations

Condition Hierarchy (Ancestors)

Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2009
• First Posted: June 25, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 24, 2013

Record last verified: 2013-12

Locations

IN (1)