Underscoring the Diversity Issue in Dermatology: Clinical Trials, Therapeutics, and Care Management

Most counties with Black, Hispanic, and Native American majorities offer no access to dermatologists, fueling disparities in both quality of care and burden of disease among diverse patients with skin disorders.

A Sunday session at the American Academy of Dermatology 2022 meeting, “Addressing Unmet Needs in Diverse Populations: Therapeutic, Aesthetic, and Investigational Approaches,” spotlighted the high risk of skin disorder morbidity that minority populations face. Especially affected are Black children, who are more likely to report factors that exacerbate disease severity, such as exposure to tobacco smoke, living in multiple households, and having caregivers with low educational attainment.

Socioeconomic status plays a significant role in these associations, and not all minority populations are exposed to these conditions. Disparities in care also stem from the criteria used by health care providers and dermatologists to diagnose and treat patients with skin disorders.

Amy J. McMichael, MD, professor and chair, Department of Dermatology, Wake Forest Baptist Medical Center, explained that for dermatological conditions such as atopic dermatitis, acne, and psoriasis, characteristic disease manifestations of White patients, such as hyperpigmented plaques and papules that are bright red or pustular, are not as apparent in diverse patients and may consequently be overlooked.

McMichael noted that issues such as post-inflammatory hyperpigmentation and keloidal scarring are sequelae that are more common in patients of color and could lead to long-term negative quality of life.

“The fact that patients can get severe scarring from acne is because nobody was aggressive enough with their treatment,” she added. “Black patients were much less likely to receive orals, topicals, and isotretinoin compared with White patients in a 2020 study of Optum electronic medical record data.”

Black patients with psoriasis have been shown to be 69% less likely to receive biologic therapies. Current therapies for psoriasis are considered to be safe and effective for use in diverse ethnic groups, but McMichael highlighted that a majority of the clinical trials that investigated these medications included mostly White cohorts.

A recent study by JAMA Dermatology indicated that psoriasis studies included the least diversity of all dermatologic clinical trials, with only 12.1% of studies recording at least 20% non-White participants. Overall, inclusion of minority groups remained unchanged over the past decade for dermatology clinical trials.

“We’re going to have to assume, until clinical trials recruit more people of color, that the drugs are going to work in those patients,” said McMichael. “We also have to increase the number of people of color who are doing dermatologic studies.”

Regarding therapeutic advances in dermatology, there remains no FDA-approved treatments for repigmentation of vitiligo. Current management strategies for the condition includes stabilization and maintenance via corticosteroids, calcineurin inhibitors, and narrow-band ultraviolet B phototherapy.

Several clinical features have also been associated with therapeutic outcomes, such as anatomic site, age of patient, and duration of therapy.

Progress in repigmentation for patients with vitiligo was reported at the AAD meeting, in a study on the use of ruxolitnib cream monotherapy.

However, the issue of diversity representation was again referenced by Pearl E. Grimes, MD, director, Vitiligo and Pigmentation Institute of Southern California, and clinical professor, Division of Dermatology, David Geffen School of Medicine at University of California, who said the smaller share of Black patients in the TRuE-V1 and TRuE-V2 trials was somewhat problematic.

Vitiligo has been shown to have an equal incidence across all racial subgroups, but Grimes noted that the mental health burden of the disease is known to be much higher in patients of color whose contrasting darker skin appears much more prominently to white patches than lighter skinned individuals.

“If you go around the globe, the data is suggesting that the quality of life for people of color with vitiligo is substantially more affected. Patients experience low self-esteem and low self-worth. They feel stigmatized, ostracized. It's a little bit overwhelming in every aspect,” Grimes said.

“Looking at the centers around the United States that specialize in vitiligo in 2022, there are only 6 centers. And when you look at the care that patients receive, maybe triamcinolone in many instances, Medicaid does not cover that—clearly from a medical socioeconomic perspective, there are so many unmet needs.”

Grimes discussed the need to train the new generation of physicians who are interested in vitiligo on the impact of socioeconomic status and race. Additionally, she stressed that the only way to address the unmet need of diversity in dermatology clinical trials is to take the studies to the community and to the physicians who are more likely the caregivers of patients.

McMichael and Grimes both mentioned they are either working with or are aware of pharmaceutical companies who are taking steps to promote diversity initiatives centered on recruiting patients in smaller community-based clinical trials and training dermatologists.

“There’s a pharmaceutical company who wants to help mentor people who are interested in doing clinical trials in their office. I think that’s a nice start,” said McMichael.

“Hopefully by June there'll be a mentorship in place, preferably in a college society, that will help people meet others who are already doing clinical trials, potentially allow these people to go to a site and learn about clinical trials. I'm hopeful that with these companies willing to take a chance on new investigators, we’ll actually see more of that happening.”