TITLE

PI-9

AUTHOR(S)
Mitchel, J. T.; Vicaria, M.; Eyerdam, D. H.; Meinking, T. M.
PUB. DATE
February 2006
SOURCE
Clinical Pharmacology & Therapeutics;Feb2006, Vol. 79 Issue 2, pP9
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Pediculosis is increasing rapidly in the US and throughout the world due to drug resistance. This new investigational treatment for head lice, L.A. is pesticide free, works as a suffocant, will not cause resistance, and is environmentally safe. The mechanism of action of L.A. is to stun the respiratory spiracles open, thus enabling the treatment to mechanically block the respiratory system. Two randomized, observer-blinded, dose ranging Phase II clinical trials were conducted to evaluate the safety and efficacy of L.A. There were two treatments of 10 minutes each, one week apart. Subjects came from an area of high lice infestation. There were 81 subjects who entered and 79 who completed study 1; 42 subjects were entered and 39 completed study 2. The primary efficacy variable was the % of subjects with treatment success at the end of the study. On Day 1 post-treatment in Study 1, L.A. (5% and 10%) and RID treatment groups had ≤2.0 mean live lice, while the vehicle placebo group had a mean of 7.7 live lice (p=0.004). Kill rate was >80% in those receiving active treatment compared to <20% in the placebo group (p<0.001). At Day 15, all treatments demonstrated 70% success. In the minimum effective dose study, the hair was fully saturated during treatment. Results showed that 5% and 2.5% L.A. demonstrated an overall treatment success of 90.5% and 81.0%, respectively. Five subjects experienced expected adverse events during study 1, and 1 subject in study 2. The L.A. 5% treatment was efficacious and the dose of choice.Clinical Pharmacology & Therapeutics (2005) 79, P9–P9; doi: 10.1016/j.clpt.2005.12.030
ACCESSION #
22412570

 

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