Abstract | OBJECTIVE: SUBJECTS AND MATERIALS: Two phase-3, multicenter, randomized, evaluator/investigator-blinded studies compared 0.9% spinosad without nit-combing to 1% permethrin with combing (according to product instructions) in 1038 males and females aged > or =6 months. Spinosad-with-combing groups were included for descriptive, noninferential purposes only. Within 391 households, youngest members having > or =3 live lice were designated primary participants. All household members with lice received the same treatment. Participants administered product 1 to 2 times during the 21-day home-use period on the basis of complete lice eradication after a single use or the presence of lice requiring a second treatment. Scalp evaluations were performed at baseline, day 7, and day 14 (and day 21 for participants treated twice). The primary end point was the proportion of lice-free primary participants 14 days after last treatment. RESULTS: A total of 84.6% (study 1) and 86.7% (study 2) of spinosad-treated participants were lice free versus 44.9% and 42.9% permethrin-treated participants (P < .001). Most spinosad-treated participants required 1 application, whereas most permethrin-treated participants required 2 applications. Few adverse events were reported, but those occurring were mild to moderate, including eye irritation ( permethrin), ocular hyperemia, and application-site erythema/irritation (both medications). No laboratory measure changed significantly. CONCLUSIONS:
Spinosad, which did not require nit combing, was significantly more effective than permethrin in 2 studies reflecting actual-use conditions, and most spinosad-treated participants required only 1 application. Spinosad is a more convenient and effective treatment for pediculosis capitis.
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Authors | Dow Stough, Susan Shellabarger, John Quiring, Alvin A Gabrielsen Jr |
Journal | Pediatrics
(Pediatrics)
Vol. 124
Issue 3
Pg. e389-95
(Sep 2009)
ISSN: 1098-4275 [Electronic] United States |
PMID | 19706558
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Drug Combinations
- Insecticides
- Macrolides
- Permethrin
- spinosad
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Child
- Child, Preschool
- Drug Combinations
- Female
- Humans
- Infant
- Insecticides
(adverse effects, therapeutic use)
- Lice Infestations
(drug therapy)
- Macrolides
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Permethrin
(adverse effects, therapeutic use)
- Scalp Dermatoses
(drug therapy)
- Single-Blind Method
- Young Adult
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