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

Pediculosis Clinical Trial

Official title:

A Randomized, Single-Dose, Parallel Group, Comparative Pharmacokinetic (PK) Study to Evaluate Malathion Gel 0.5% Versus Ovide (Malathion) Lotion 0.5% in Patients With Pediculosis Capitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927407
• Other study ID #: MALG-0603
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2009
• Last updated: December 21, 2013
• Start date: July 2009
• Est. completion date: August 2009

Study information

• Verified date: December 2013
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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%.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lice Infestations
• Pediculosis

Intervention

Drug:
• Malathion gel 0.5%
Malathion gel 0.5% applied to the scalp for 30 minutes
• Malathion lotion 0.5%
Malathion lotion 0.5% applied to scalp for 12 hours

Locations

Country	Name	City	State
India	Investigator Site	Rabale	Navi Mumbai

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

India, 

References & 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 Crème Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol. 2007 Jul-Aug;24(4):405-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of blood and urinary levels of malathion and metabolites		48 hours	Yes
Secondary	Measure cholinesterase levels and compare to malathion metabolite levels		48 hours	Yes