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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
Author(s) -
Meinking Terri L.,
Vicaria Maureen,
Eyerdam Deborah H.,
Villar Maria Elena,
Reyna Susan,
Suarez German
Publication year - 2007
Publication title -
pediatric dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.542
H-Index - 73
eISSN - 1525-1470
pISSN - 0736-8046
DOI - 10.1111/j.1525-1470.2007.00460.x
Subject(s) - malathion , lotion , medicine , permethrin , pediculosis , randomized controlled trial , toxicology , surgery , pesticide , traditional medicine , biology , botany , infestation , agronomy
One hundred seventy‐two subjects with head lice participated in a five‐way, investigator‐blinded, parallel‐group, active‐controlled study comparing 0.5% malathion gel (30, 60, and 90 minutes applications), Ovide ® Lotion (0.5% malathion), and Nix ® Crème Rinse (1% permethrin). All subjects were treated on day 1. Participants were reevaluated at day 8 ± 1 and those with live lice were retreated with the same product, for the same duration as day 1. Cure, defined as the absence of live lice, was evaluated 14 ± 2 days after the last treatment and 161 subjects completed the study according to the protocol. Compared to Nix, treatment success rates were statistically superior for all malathion gel and Ovide ® groups. Retreatment rate for Nix was 70%, which was statistically more than the malathion groups. The highest treatment success rates were observed for the 30‐minute malathion gel (98% intent‐to‐treat and 100% per‐protocol [PP]) and the 8 to 12 hour Ovide ® application (97% intent‐to‐treat and 100% PP). In conclusion, the 30‐minute malathion gel, which contains the same ingredients and concentrations as Ovide ® , provides comparable efficacy, offers increased safety and is more cosmetically acceptable than Ovide ® .