Helping an acne trial overcome recruitment challenges

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Early clinical-stage US dermatology biotech Botanix Pharmaceuticals was keen to accelerate the clinical development of its lead acne product and looked to Australia to take advantage of the country’s supportive regulatory environment and R&D tax rebate scheme. 

The Background 

Acne is one of the most common skin diseases in the world, with approximately 85% of people between the ages of 12 to 24 experiencing at least minor acne [1]

Early clinical-stage US dermatology biotech Botanix Pharmaceuticals was keen to accelerate the clinical development of its lead acne product and looked to Australia to take advantage of the country’s supportive regulatory environment and R&D tax rebate scheme. 

Challenge 

Working with the acne company, Novotech was able to reduce potential patient consent challenges from the initial trial protocol. 

Our Actions 

While together with private clinical trial site and clinical investigators, Novotech was able to over recruit patients with moderate to severe acne from four sites in Australia. 

Novotech’s team for Botanix managed the trial from start to finish, providing clinical trial and project management, medical monitoring, data management and statistical analysis, medical writing and drug safety surveillance. Novotech used several leading IT platforms, such as SharePoint, VieDoc and its own Clinical Trial Management System (CTMS), as part of its clinical trial and data management for Botanix. 

Results 

Armed with positive data from the trial, Botanix was able to start planning phase II trial activity from its lead acne product [2].  

“Novotech was in key helping us work with the ethics committees involved and navigate this potential clinical trial hurdle. Also having worked with the CRO before, we were comfortable and confident in their clinical trial and project management processes. We appreciate their approach of being a research partner, rather than just a service provider.” 
Botanix Pharmaceuticals

Vice President of Clinical Research and Regulatory Affairs
Mark Davis