Safety, Efficacy, and Patient Satisfaction With OnabotulinumtoxinA for the Treatment of Upper Facial Lines in Japanese Subjects.

BACKGROUND: OnabotulinumtoxinA treatment for glabellar lines (GL) or crow's-feet lines (CFL) was previously studied in Japanese subjects. OBJECTIVE: To assess safety and efficacy of repeated onabotulinumtoxinA for moderate to severe GL and CFL in Japanese subjects. METHODS: This 13-month, double-blind, Phase 3 study randomized subjects to onabotulinumtoxinA 44 U (n = 48) or 32 U (n = 53) for CFL and GL for up to 5 treatments (CFL: 24 U or 12 U; GL: 20 U). Outcomes included proportion of subjects achieving none/mild severity at maximum smile (CFL) and maximum frown (GL), using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A); proportion of ≥1-grade improvement responders at maximum smile and at rest (CFL), at maximum frown and at rest (GL); subject-reported outcomes; and safety. RESULTS: Most subjects were responders (none/mild on FWS-A; CFL: 89.6% [44 U], 84.9% [32 U]; GL: 93.8% [44 U], 98.1% [32 U]) on Day 30. Across treatment groups, responder rates were consistent over time and treatments. Most subjects were satisfied with improved CFL appearance and with treatment. Incidence of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs across groups was similar. All TEAEs but one (peritonitis) were mild or moderate. CONCLUSION: Repeated onabotulinumtoxinA was effective and well tolerated.

Improvements in satisfaction with skin after treatment of facial fine lines with VYC-12 injectable gel: Patient-reported outcomes from a prospective study.

BACKGROUND: VYC-12, a hyaluronic acid injectable gel, is designed to treat fine lines and provides improvements in other skin quality attributes. A prospective study demonstrated the safety and effectiveness of VYC-12 for the improvement of fine lines as measured by changes in skin texture. AIMS: To evaluate patient-reported outcomes in subjects treated intradermally with VYC-12 in the cheeks, forehead, and neck (optional) in the prospective study. METHODS: Subjects received an initial treatment of VYC-12 (N = 131), with a touch-up treatment, if deemed necessary, offered 30 days later, and optional repeat treatment 9 months after initial or touch-up treatment. Subjects completed the FACE-Q Satisfaction With Skin scale and assessed willingness to recommend treatment to a friend at baseline, months 1, 4, 6, and 9, and month 1 after repeat treatment. Subjects also evaluated their return to normal daily social activities. RESULTS: Satisfaction with skin improved from baseline in 90.8% of subjects at month 1, 88.4% at month 4, 83.6% at month 6, 76.4% at month 9, and 91.9% at month 1 after repeat treatment (P < .001, all time points). At least 94% of subjects returned to normal daily social activities one day after treatment (initial, touch-up, or repeat). More than 80% of subjects said they would recommend treatment to a friend at all time points through month 9 (97% at month 1 after repeat treatment). CONCLUSION: Treatment with VYC-12 significantly improved satisfaction with skin in the majority of subjects, with most subjects returning to normal activities 1 day after treatment.

VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study.

OBJECTIVE: Evaluate safety and effectiveness of VYC-12 (Juvéderm Volite; an injectable crosslinked hyaluronic acid gel designed to improve skin quality attributes such as surface smoothness and hydration) for facial intradermal injection. MATERIALS AND METHODS: In a prospective, single-arm study, subjects with moderate/severe cheek skin roughness per Allergan Skin Roughness Scale (ASRS) received VYC-12 in the cheeks and forehead, and/or neck, with touch-up treatment to correct asymmetry 30 days later and optional repeat treatment 9 months after last treatment. The primary effectiveness measure was ASRS responder rate (percentage of cheeks with ≥1-point improvement from baseline) at month 1. Skin hydration was instrument-assessed. RESULTS: Of 131 subjects treated, 31 (23.7%) received touch-up treatment. ASRS responder rate was 96.2% at month 1, 76.3% at month 4, 34.9% at month 6, and 87.1% after repeat treatment. Responder rate in cheeks with severe baseline roughness was 93.8%, 83.1%, and 52.3% at months 1, 4, and 6, respectively. Skin hydration improved significantly (P<0.01) from baseline at all timepoints through month 9. Injection site responses were as expected. All treatment-related adverse events were mild/moderate. CONCLUSION: VYC-12 safely and effectively improved skin smoothness up to 6 months and hydration lasting 9 months.

OnabotulinumtoxinA (Botox) in the Treatment of Crow's Feet Lines in Japanese Subjects.

BACKGROUND: This study evaluated the safety and efficacy of onabotulinumtoxinA in Japanese subjects with crow's feet lines (CFL). METHODS: This phase 3, multicenter, double-blind, randomized study included 2 treatment periods: 6-month placebo-controlled period followed by a 7-month open-label period. In period 1, subjects with moderate to severe CFL received onabotulinumtoxinA 24 U (n = 104) or 12 U (n = 99), or placebo (n = 97). In period 2, placebo subjects switched to onabotulinumtoxinA 24 U or 12 U (double-blind dose). Up to 5 total treatments were permitted for subjects meeting re-treatment criteria. The primary efficacy measure was the proportion of investigator-assessed responders (achieving CFL severity of none or mild at maximum smile using the Facial Wrinkle Scale with Asian Photonumeric Guide [FWS-A] at day 30 of treatment 1). Additional endpoints included other responders (achieving at least 1-grade improvement at maximum smile and at rest using the FWS-A at day 30), responders at other time points, duration of effect, subject-reported outcomes, and safety. RESULTS: All efficacy endpoints were met. At day 30, the proportion of subjects achieving none or mild severity at maximum smile was significantly greater (P < 0.001) in the onabotulinumtoxinA 24 and 12 U groups (68.3 and 56.6%, respectively) compared with the placebo group (8.2%). Efficacy results were consistent over repeated treatments, and subjects' self-assessed outcomes were similar to investigator-assessed results. CONCLUSIONS: Treatment with onabotulinumtoxinA 24 and 12 U improved the appearance of CFL in Japanese subjects and was well tolerated, with no new safety findings. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .