New AK Treatment Studied at Clinical Research Center of the Carolinas Receives FDA Approval

March 02 , 2021

We often say in clinical research that it is just as important when we discover that a drug doesn’t work as when we discover a blockbuster cure. But nothing beats seeing a medication your team worked on making it all the way to FDA approval. And that is why we are absolutely thrilled to share that Almirall LLC has received FDA approval for KLISYRI, their first-in-class topical treatment for actinic keratosis. 

That’s a lot to unpack. 

Let’s start with FDA approval. New treatments are put through a rigorous series of trials beginning with the pre-clinical phase, or laboratory testing. Next, clinical research begins – that is, the drug is tested in people for the first time.  Phase 1 is primarily a safety study and involves healthy volunteers. Phases 2 and 3 are safety studies too, but they are also focused on whether the drug works. Clinical Research Center of the Carolinas was a part of both phase 2 and 3 trials for KLISYRI. Finally, all the data is collected and submitted to the FDA where their experts answer this important question:

Do the benefits of this treatment outweigh the risks?

Next, what is actinic keratosis

Actinic keratosis, or AK, is a rough, scaly patch of skin that results from years of sun damage. That doesn’t sound so bad, does it? Here’s the problem. Sometimes these patches turn into a potentially dangerous form of skin cancer called squamous cell carcinoma. That’s why finding effective ways to treat AKs before that happens is so important. 

What do we mean by “first-in-class?” 

According to the FDA, first-in-class drugs are those that use “a new and unique mechanism of action.” That’s a fancy way of saying the drug treats the condition in a way that’s never been done before. While there can be safety risks, first-in-class drugs are innovative, cutting edge, and often provide unprecedented benefits, especially for patients who are not responding well to what they are currently taking.


  • KLISYRI is a topical ointment applied to AKs once a day for only 5 days. 
  • 5 times more patients achieved complete (100%) clearance with KLISYRI vs Placebo.
  • KLISYRI will be available to everyone by Spring 2021.