Our team at ethica CRO managed a series of investigator-initiated trials (IITs) for aUS-based pharmaceuticals company. The main objective of these trials was to demonstrate the efficacy of botulinum toxin (BTX) for a number of off-label indications for aesthetic applications, as BTX was only approved for the treatment of glabellar lines at the time. Another purpose of these IITs was to enhance understanding of the effects and impacts of this drug, such as patient satisfaction, diffusion, duration of action, and social perception, among other factors.
Ensuring Data Consistency within a Diverse CF Population
Hundreds of millions of people around the world suffer from respiratory diseases—asthma, cystic fibrosis (CF), and bronchiectasis being among the most prevalent conditions. CF affects 1 in every 3600 children born in Canada, making it the most common fatal genetic disease in our country. There is currently no cure for CF, but there exist treatment options that have been shown to improve the symptoms and quality of life of people living with this debilitating condition.
Meeting Unique Technical Challenges: The Case of FDA’s First Approval of a Dermal Filler for the Treatment of Acne Scars
Acne is the most common skin disorder in the U.S. affecting 40-50 million people. Up to 95% of people with acne may go on to suffer from scarring. Acne scarring can have significant impact on well-being and quality of life, particularly for people with moderate to severe acne scarring.