A peer reviewed journal article highlighting the efficacy and safety of prabotulinumtoxinA (Jeuveau) for the treatment of moderate to severe glabellar lines, also known as frown lines between the eyes, in adult patients with Skin of Color (SOC), was published recently in Dermatologic Surgery, Evolus Inc announces in a media release.
Patients with SOC differ from those without SOC in several important ways, including skin structure and the pathophysiology of aging. Despite widespread use of botulinum toxins, limited data has been available on the comparative outcomes of patients with and without SOC. Although 70% of all aesthetic procedures were performed in Caucasians in 2018, a significant and growing percentage of procedures were performed in non-Caucasians, including Hispanics (13%), African Americans (9%), and Asians (6%). This is noteworthy since non-Caucasians are projected to comprise more than 50% of the US population by 2044.
“With the increasing demand for aesthetic procedures by patients with SOC, it is critically important to understand potential differences in effectiveness as well as adverse events between SOC and non-SOC populations. This important study of pooled data provides information for Dermatologists of a non-statistical difference in responder rates and headache in SOC as compared to non-SOC patients for this neurotoxin.”
— Susan C Taylor, MD, the Sandra Lazarus Professor of Dermatology, University of Pennsylvania
“Because existing clinical trial data is limited, the data in this article are an important contribution to the body of research around facial aesthetic procedures in patients with skin of color. We’re pleased that Jeuveau is proven to be a safe and effective option for patients with skin of color who are looking for neurotoxin treatment.”
— Rui Avelar, Chief Medical Officer and Head of Research & Development at Evolus
Focus on Pooled Data
The article focuses on pooled data from 492 Jeuveau-treated patients who participated in two US multicenter, randomized, double-blind, placebo-controlled, single-dose phase III clinical studies. These patients were given a single dose of 20 units of Jeuveau and outcomes were compared between those with and without SOC, as defined by Fitzpatrick skin Types IV + V + VI and I +II + III, respectively.
Outcomes were also compared between race-based subsets of each population: those with SOC who self-identified as Black/African American and those without SOC who self-identified as White. Responder rates among patients with SOC (n = 140) were lower than those without SOC (n = 352), by 5.9% on average across all visits. At Day 30, responder rates were 94.0% and 96.0%, respectively.
At no time point were differences statistically significant. Headache was the most common treatment related adverse event (AE), occurring in 12.1% and 8.2% of patients with and without SOC, respectively, the release explains.
Jeuveau is marketed in the United States by Evolus. The product is marketed by a partner in Canada as Nuceiva with European launch planned for early 2022.
[Source(s): Evolus Inc, Intrado GlobeNewswire]