Diversity in Aesthetic Clinical Trials

Much has been written about the need for increased diversity in clinical trials. Addressing the underrepresentation of minority racial and ethnic groups in clinical trials is essential to advancing health care equity and reducing the existing significant disparities that exist in our country across various communities. In 2021, Pfizer released a report looking at 213 trials with 103,103 participants, spanning areas from vaccines and cancer to inflammatory and autoimmune diseases. In these therapeutic trials, 78.6% of trial participants were white; 17% self-identified as Black or African American, and just 2.2% were Asian. When considering just oncology, Black or African American and Hispanic or Latino enrollment was reflected with only 16% and 6.5%, respectively, of patient participants.¹

What are the implications when it comes to aesthetic clinical trials? There is no one set standard definition of beauty and people from different ethnic and racial backgrounds age in different ways from those of other groups. Generally speaking, with chronological aging, we can expect wrinkles, the redistribution of soft tissue, and atrophy of fat, but the ways in which we experience these clinical changes occur at different time points in our lives.

For example, non-white patients may develop rhytids at a later age because they have more melanin in their skin which allows for greater photoprotection. Therefore, these groups are less susceptible to sun-induced damage and the same clinical signs such as photoaging may present at a later stage in life. Additionally, compared to patients with skin of color, white patients tend to have a thinner dermis which may also accelerate the appearance of broken blood vessels, rougher skin texture and dyspigmentation. Similarly, the loss of connective tissue will not occur at the same speed for all racial groups as many Black women may find that because they may have more collagen than their White counterparts, they may not develop wrinkles until a decade or two later.

With regard to facial structural differences, common changes occur as a result of bone reabsorption, soft tissue redistribution, and the loss of fat in areas such as the temple, cheeks, and chin. However, in Black individuals these facial changes are more likely to occur in the central areas of the face, which may result in dark circles under the eyes, fullness of the upper eyelids, development of jowls, and loss of lip volume. By contrast, Hispanic and Latino individuals may experience more significant drooping of the mid-cheek area, prominent nasolabial fold lines, as well as baggy lower eyelids.

The implications of these differences, taken together with varying cultural differences in perception of beauty, call for a need for sensitivity when treating patients from different backgrounds. While we can increase the enrollment of various ethnic and racial groups, we must also consider that their aesthetic goals may not be the same and their needs may differ. For two similarly aged women of varying backgrounds, a mid-face volume filler trial may not warrant filling both individuals to the same fullness. For energy-based devices, we know that we need to take care in darker skin types due to the greater risk for post-inflammatory pigmentation. However, we need to be cognizant that clinical outcomes that we desire to achieve may only come at higher energy levels since the skin is thicker in these patients.

Thus, while increasing the diversity in clinical trial participation remains a significant need, in aesthetic clinical trials the situation is more complex and nuanced due to the structural differences in aging that take place at different time points for different patients, as well as the cultural desires and preferences groups may have with the particular lens that they view beauty.

Ultimately, as human beings we want to look and feel our absolute best. Therefore, not taking a cookie cutter approach to rejuvenation remains paramount. We must be sensitive to the desires and needs of individuals as well as group preferences to ensure that we carefully design aesthetic clinical trials to be inclusive and accommodating across gender, race, and ethnicity. 

1. Rottas M, Thadeio P, Simons R, et al. Demographic diversity of participants in Pfizer sponsored clinical trials in the United States. Contemp Clin Trials. 2021;doi:10.1016/j.cct.2021.106421.