An updated version of the FDA-approved Sklice clinical trial has been published on the ClinicalTrials.gov website.
The Sklice trial was a Pharmacokinetics (PK) study of lice-infected children between 6 months and 3 years of age, using 0.5% Ivermectin cream combined with standard pharmacokinetic outcome measures to determine overall safety. Summary results are published at ClinicalTrials.gov, and a more detailed version of the FDA review can be found here.