Author Affiliations: Burke Pharmaceutical Research Inc, Hot Springs, Arkansas.
I agree with the “Authors' Conclusions”; I disagree with the commentary. It does not appear that the authors had all of the data including the full study protocol and final study report as purported, but rather it appears that the comments were based solely on the report by Stough et al, which was a summary of the safety and efficacy of spinosad (Natroba; ParaPro LLC) and the brief information found on clinicaltrials.gov. The CONSORT guidelines were not used to write the report. Trying to apply these guidelines to a report written for the journal Pediatrics does not make sense and thus led to inappropriate comments and false assumptions. The authors of the Pediatrics article were not trying to write the article as a strict CONSORT style report but for publication of 2 clinical trials through the peer-review process.
Stough D. Efficacy and Safety of Spinosad Cream Rinse for Head Lice—Reply. Arch Dermatol. 2012;148(9):1070. doi:10.1001/archdermatol.2012.1997