PrabotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines in Adult Patients With Skin of Color: Post Hoc Analyses of the US Phase III Clinical Study Data

• Published in: Dermatologic surgery Vol. 47; no. 4; p. 516
• Main Authors: Taylor, Susan C, Grimes, Pearl E, Joseph, John H, Jonker, Anneke, Avelar, Rui L
• Format: Journal Article
• Language: English
• Published: United States 01.04.2021
• Subjects: Adult; Botulinum Toxins, Type A - administration & dosage; Botulinum Toxins, Type A - adverse effects; Female; Forehead; Humans; Injections; Male; Middle Aged; Neuromuscular Agents - administration & dosage; Neuromuscular Agents - adverse effects; Skin Aging - drug effects; Skin Pigmentation; United States; United States
• ISSN: 1524-4725
• DOI: 10.1097/DSS.0000000000002864

Limited US clinical data are available on the use of aesthetic products in patients with skin of color (SOC). To compare the efficacy and safety of prabotulinumtoxinA for the treatment of glabellar lines in patients with and without SOC. Post hoc analyses were performed on the pooled population of all 492 patients treated with 20U prabotulinumtoxinA in the 2 US single-dose Phase III glabellar line clinical studies. Patients were grouped by Fitzpatrick skin Type: IV + V + VI (with SOC) versus I + II + III (without SOC). The primary efficacy end point was the proportion of responders with a ≥1-point improvement from baseline at maximum frown on the 4-point Glabellar Line Scale. Adverse events (AEs) were also summarized. 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 no time point were differences statistically significant. At Day 30, responder rates were 94.0% and 96.0%, respectively (p = .401). Headache was the most common treatment-related AE, occurring in 12.1% and 8.2% of patients with and without SOC, respectively. A single dose of 20U prabotulinumtoxinA was well tolerated and similar in effectiveness in patients with and without SOC for the treatment of glabellar lines.