Doral Fredericks, PharmD, MBA, global vice president of medical affairs and outcomes research at Organon, discusses the lack of focus on pregnancy and menopause in dermatology research and the implications for clinical practice. Despite being critical hormonal transitions in a woman’s life, these periods remain significantly understudied in dermatological research.

Read More

The hesitance to include pregnant and postpartum patients in clinical trials is rooted in valid concerns regarding fetal exposure and potential drug transfer through breast milk. Consequently, much of the knowledge about skin diseases in these groups stems from patient registries and longitudinal data rather than controlled trials. Fredericks notes that the gap in research extends beyond safety concerns.

Symptoms during these transitions are frequently viewed as normal or an inevitable aspect of aging, leading to a lack of urgency in exploring them further. Additionally, the biological complexity of hormonal changes presents challenges for trial design. Unlike the more predictable hormonal shifts seen in puberty or conditions like acne, the fluctuations during pregnancy, postpartum, and menopause are diverse and difficult to standardize for research.

Fredericks points out a knowledge gap among healthcare providers, where while some are familiar with the physiological changes of pregnancy, understanding of pregnancy-specific skin conditions is often inconsistent. This can lead to misdiagnoses and underdiagnoses, which are not readily recognized as failures in research.

The immunological consequences of these hormonal changes are significant and frequently counterintuitive. For instance, during pregnancy, elevated estrogen can lead to an immune shift that worsens conditions like atopic dermatitis but may improve others, such as psoriasis. In contrast, menopause brings sustained low estrogen levels, which can increase psoriasis flare-ups and diminish skin barrier function due to reduced lipid production and hydration.

Fredericks emphasizes that the resurgence of conditions like atopic dermatitis in older women is a clinically relevant issue, attributed to a decline in skin barrier function and immune aging—factors that remain largely unrecognized in both research and treatment paradigms.