Andrew Alexis, MD, MPH: Findings on Trifarotene for Acne Sequelae in Skin of Color

All skin phototypes may experience improvements in their overall disease severity (ODS) and post-acne vulgaris hyperpigmentation index (PAHPI) scores following treatment with trifarotene, according to new findings, with a combined plan of trifarotene and other skincare methods leading to greater patient satisfaction and adherence.¹

These findings were the result of new research led by Andrew F. Alexis, MD, MPH, known for his work as professor of clinical dermatology at Weill Cornell Medicine. Alexis recently spoke with HCPLive regarding his team’s new phase 4 study on trifarotene treatment of acne sequelae among patients with diverse skin types.

“This study that we're discussing today, which relates to the management of postinflammatory hyperpigmentation associated with acne using a fourth generation retinoid called trifarotene,” Alexis explained. “The impetus for studying this is the recognition that post-inflammatory hyperpigmentation is a huge burden for patients with acne, especially those with skin of color. In fact, we find that post-inflammatory hyperpigmentation is often the driving force for patients with acne to come and see a dermatologist, especially those who have higher Fitzpatrick skin types.”

Alexis added that many of these patients feel that the hyperpigmentation is just as impactful, and sometimes even more impactful, to them compared to the acne itself.

“So it's a real world challenge when treating patients to address their concerns about the acne itself, as well as the sequelae of acne, which included post-inflammatory hyperpigmentation,” Alexis explained.

Trifarotene itself had been formulated as a skin-selective retinoid and worked through stabilization of patients' skin and via high receptor selectivity for the retinoic acid receptor (RAR) gamma. This is the predominant RAR subtype known to be expressed within the epidermis.²

Later, Alexis was asked about the study itself as well as its primary endpoints. He noted that it was a randomized, phase 4, double-blind, parallel-group study of individuals in the 13–35 year age range with moderate acne vulgaris as well as acne-induced hyperpigmentation. These subjects were given trifarotene or vehicle, in addition to a skincare regimen involving cleanser, moisturizer, and sun protection for 24 weeks.

“There were a couple endpoints of note in the study,” Alexis said. “The primary endpoint is something called the overall disease severity score, or ODS score, which takes a look at the overall severity of hyperpigmentation. The primary endpoint was reduction in this ODS score at the 6 month mark or Week 24. But there were some interesting secondary endpoints, specifically the so called PAHPI score, which is post-acne hyperpigmentation index score, taking into account the number of lesions, size of lesions ,and the intensity of those of those lesions.”

To find out more about the study’s background, view the full interview posted above.

The quotes contained here were edited for the purposes of clarity. Alexis has served as a consultant and/or advisory board member for Novartis, Leo, Sanofi Regeneron, UCB, Dermavant, Galderma Laboratories LP, Beiersdorf, Unilever, Valeant, L'Oreal, Scientis, Bausch Health, Allergan, Arcutis, Janssen, Almirall, AbbVie, Bristol Meyers Squibb, and Sol-Gel.

References

1. ^{Alexis A, Del Rosso J, Stein-Gold L, et al. (2024). Importance of treating acne sequelae in skin of color: 6-month phase IV study of trifarotene with an appropriate skincare routine including UV protection in acne-induced post-inflammatory hyperpigmentation. Int J Dermatol. https://doi.org/10.1111/ijd.17189.}
2. ^{Aubert J, Piwnica D, Bertino B, Blanchet-Rethore S, Carlavan I, Deret S, et al. Nonclinical and human pharmacology of the potent and selective topical retinoic acid receptor-gamma agonist trifarotene. Br J Dermatol. 2018; 179: 442–456.}