The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of head lice infestation. Specifically, this guidance addresses the Agency’s current thinking regarding the overall development program and clinical trial designs of drugs to support approval of an indication for topical treatment of head lice infestation. The information presented will help sponsors plan clinical trials, design clinical protocols, and conduct and appropriately monitor clinical trials. Development plans should be discussed with the review division before initiating trials to ensure that the trial design meets defined objectives. This guidance does not contain discussion of the general issues of statistical analysis or clinical trial design. Those topics are addressed in the ICH guidances for industry E9 Statistical Principles for Clinical Trials and E10 Choice of Control Group and Related Issues in Clinical Trials, respectively. This guidance focuses on specific drug development and trial design issues that are unique to the study of head lice infestation.
This guidance also does not contain discussion of nonclinical or chemistry, manufacturing, and controls issues. See the ICH guidance for industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.