Status:
COMPLETED
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice
Lead Sponsor:
Sun Pharmaceutical Industries, Inc.
Conditions:
Pediculosis
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established h...
Detailed Description
This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The o...
Eligibility Criteria
Inclusion
- Confirmed active head lice infestation
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT00963508
Start Date
August 1 2009
End Date
March 1 2010
Last Update
June 13 2014
Active Locations (7)
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1
Investigator Site
Hot Springs, Arkansas, United States
2
Investigator Site
Sacramento, California, United States
3
Investigator Site
Kissimmee, Florida, United States
4
Investigator Site
Miami, Florida, United States