Status:
COMPLETED
Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice
Lead Sponsor:
Sun Pharmaceutical Industries, Inc.
Conditions:
Pediculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 patien...
Detailed 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, wh...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00927407
Start Date
July 1 2009
End Date
August 1 2009
Last Update
December 24 2013
Active Locations (1)
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1
Investigator Site
Rabale, Navi Mumbai, India