Introduction Atopic dermatitis (AD), often called eczema, is a complex disorder involving skin barrier function abnormalities and skin inflammation. It is the most common skin condition in children under the age of 11 years – about 50 percent of patients develop the disease by the age of one year and up to 85 percent by...
Acne is the most common skin condition in the U.S., affecting up to 50 million Americans annually. In this white paper, we explore the history and future of acne treatment, with a focus on emerging therapies that may help patients with moderate to severe acne gain and maintain control of their acne. Acne is a...
Short-duration acute pain management trials involve a variety of complex factors that must be taken into account for successfully evaluating the safety and efficacy of a new analgesic product. These five considerations are key. 1. Choosing the Right Model There are a number of established pain models for clinical research, each with its own type, intensity,...
Knowledge of a disease’s natural history is essential to building the scientific foundation for an effective clinical development program. That’s especially the case when developing drugs to treat rare diseases, which by their very nature are poorly understood. Natural history studies don’t just track the course of diseases over time, but identify demographic, genetic, environmental,...
Designing and conducting psoriasis clinical trials is tricky. After all, psoriasis is a highly variable group of conditions that produce a range of debilitating and often subjective symptoms. So how do researchers assess efficacy in novel psoriasis treatments? Read on for the answer. Considerations for Psoriasis Trials In clinical practice, broad global assessments are used...
What do you do when patients are too embarrassed to talk about what’s wrong with them? It was a trial for fecal incontinence, and patients wanted help – they just didn’t want to admit it. We needed a new outreach and recruitment process, so we tried radio, outdoor, and subway. We rigorously tracked what worked...
No guesswork here. It’s a combination of experience and that often-overlooked scientific discipline called common sense. We were conducting a Phase 2b trial of a new treatment for nonalcoholic steatohepatitis, or NASH. And we knew three things: We knew that hepatologists would jump at the chance to enroll their patients, because the only existing treatment...
When it comes to analgesic drug development, it’s important to optimize design of early phase trials. The main objectives of studies at this stage are to: Explore a range of doses Obtain data on onset, peak effect, and duration Assess relative efficacy in comparison to established analgesics To accurately evaluate their product, sponsors need to...
Patient registry and natural history studies are often thought of as interchangeable, but there are major differences in these approaches to clinical drug development. Understanding the role of each is important, as well as understanding the distinctions on how these study designs are used in pursuing treatments for rare diseases. Patient Registries A patient registry...
Psoriasis is caused by dysregulated interactions of the innate and adaptive immune system in skin epithelium and connective tissue, including the activation and proliferation of T helper cells. As an autoimmune disorder causing widespread inflammation, it is unsurprising that psoriasis is associated with a number of non-dermatological conditions. Continued psoriasis research may give insight into the etiology...