In this episode, guest John Barbieri, MD, MBA, discusses the FDA's 2023 proposed changes to the iPledge system and the impacts of clinical trials and treatments on patients with hormonal acne.
• Intro 0:28
• John Barbieri, MD, MBA 0:42
• What does it mean to have a conditional recommendation, and why is this considered "controversial"? 1:50
• What are the reasons, such as limitations of use, that lead to a conditional recommendation? 2:48
• How would you implement these care guidelines into clinical practice? 3:53
• Why is a medication like minocycline in the conditional category relative to other medications? 5:55
• Tell us about some of the recent studies on spironolactone that have come out of the UK and France, and what we've learned from them. 7:10
• Did they monitor any lab tests during these studies? 9:57
• Can you tell us about the NIH-funded trial you are leading in the US? 10:36
• Who uses spironolactone? How do you start this drug? 11:38
• What is currently happening with iPledge? 13:04
• How will these changes work operationally? What kind of home pregnancy test is used for patients? 15:20
• When can clinicians expect these changes to iPledge to be implemented? 16:42
• Thank you, Dr. Barbieri. 17:15
John Barbieri, MD, MBA, is the director of the Advanced Acne Therapeutics Clinic at Brigham and Women's Hospital in Boston.
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Disclosures: Gelfand and Barbieri report no relevant financial disclosures.
