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Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

This study has been completed.
Sponsor:
Information provided by:
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00927472
First received: June 23, 2009
Last updated: September 22, 2010
Last verified: September 2010
History of Changes

June 23, 2009
September 22, 2010
August 2009
May 2010   (final data collection date for primary outcome measure)
Proportion of subjects free of any of lice [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00927472 on ClinicalTrials.gov Archive Site
Tolerability of treatment [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice
A Multi-Center Phase III Study to Evaluate Ovide Lotion 0.5% Formulation, for the Control of Head Lice in Pediatric Subjects and Adult Subjects With Pediculosis Capitis

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 head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.

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 objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pharmaceuticals.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Pediculosis
  • Drug: Malathion gel 0.5%
    Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.
  • Drug: Permethrin 1% rinse
    Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.
    Other Name: Nix Creme Rinse
  • Experimental: Malathion Gel
    Malathion gel 0.5% 30 minute application
    Intervention: Drug: Malathion gel 0.5%
  • Active Comparator: Nix Creme Rinse
    Nix applied to scalp for 10 minutes
    Intervention: Drug: Permethrin 1% rinse
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
June 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00927472
MALG-0817
No
Medical Director, Taro Pharmaceuticals USA
Taro Pharmaceuticals USA
Not Provided
Principal Investigator: Bryan Harvey, MD Harvey Pediatrics
Taro Pharmaceuticals USA
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP