Development of Uniform Protocol for Alopecia Areata Clinical Trials

In 2015, the National Alopecia Areata Foundation developed standardized protocols for clinical trials in alopecia areata (AA) to ensure consistency in trial design, including inclusion/exclusion criteria, safety, and outcome assessments. The aim was to facilitate data comparison across studies and encourage more clinical trials and treatment comparisons, given the lack of FDA-approved therapies for AA at the time. The protocols included a core protocol for pharmaceutical companies testing new treatments, with elements such as informed consent, disease outcome assessments, safety assessments, and a statistical significance level of 0.05. These protocols were approved in concept by Liberty IRB and were prepared for presentation to pharmaceutical companies.