USA: A recent study in Dermatologic Surgery has shown that patients with a lasting response to onabotulinumtoxinA report clinically meaningful outcomes in upper facial lines (UFL).
The researchers stress that a 1-grade improvement in the severity of UFL has a meaningful impact on patient satisfaction and correlated with a favorable improvement in psychological impacts as patients reported with validated outcome measures. Simultaneous treatment of all 3 UFLs (glabellar lines, forehead lines, and crow's feet lines) can lead to lasting, clinically significant outcomes for up to 6 months based on patient- and investigator-reported results.
The researchers report three facial regions identified in the top 5 priorities of patients for aesthetic treatment to be: glabellar lines (GL; the presence of frown lines between eyebrows), forehead lines (FHL), and crow's feet lines (CFL). They are collectively described as upper facial lines. Their appearance is known to affect self-perception, self-esteem, and mood negatively. Neurotoxin injections are the most commonly used treatment for UFL, typically performed during a single visit. The safety and efficacy of OnabotulinumtoxinA are well established for UFL.
Against the above background, Joel L. Cohen, AboutSkin Dermatology and DermSurgery, Greenwood Village, CO, and colleagues aimed to examine the association of the efficacy of onabotulinumtoxinA with patient-reported psychological impacts and satisfaction in UFL.
For this purpose, the researchers pooled data from 4 pivotal Phase 3 trials (onabotulinumtoxinA vs. placebo versus placebo in FHL + GL ± CFL, FHL ± GL, and CFL + GL for ≤180 days) and evaluated investigator-assessed ≥1-grade severity improvement on the Allergan Facial Wrinkle Scale at 30th day (responders).
For the evaluation of responder appearance-related psychological impacts and satisfaction, the researchers used Facial Line Satisfaction Questionnaire (FLSQ), Facial Line Outcomes (FLO-11) Questionnaire, and Subject Assessment of Satisfaction of Appearance (SASA).
The study led to the following findings:
OnabotulinumtoxinA patients, by primary study focus (FHL, GL, or CFL), totaled 921, 921, and 833, respectively; 786 patients received placebo.
Most patients were female, White, and aged 45 to 50 years (median).
Through 150 days, >42% FHL, >43% GL, and ≥32% CFL patients were onabotulinumtoxinA responders.
Responders reported improvements in appearance-related psychological impacts (FLO-11) and high satisfaction (FLSQ and SASA), sustained through ≥150 days.
"A ≥1-grade improvement with onabotulinumtoxinA is a clinically significant outcome in UFL, associated with long-lasting improved patient-reported psychological impacts and high satisfaction," the authors conclude.
Reference:
Cohen, Joel L. MD*; Fagien, Steven MD†; Ogilvie, Patricia MD‡; De Boulle, Koenraad MD§; Carruthers, Jean MD‖; Cox, Sue Ellen MD¶; Kelly, Regina MA#; Garcia, Julia K. PhD**; Sangha, Sara PhD**. High Patient Satisfaction for up to 6 Months With OnabotulinumtoxinA Treatment for Upper Facial Lines. Dermatologic Surgery: October 5, 2022 - Volume - Issue - 10.1097/DSS.0000000000003585 doi: 10.1097/DSS.0000000000003585