Improved Periorbital Satisfaction After Combined Mid and Upper Facial Treatment With Hyaluronic Acid Fillers and OnabotulinumtoxinA: Effectiveness and Safety Results From a Post-Marketing Study.
Abstract
[BACKGROUND] The periorbital region is among the first areas noticed in an individual, playing a crucial role in facial attractiveness and emotional expression.
[AIMS] Open-label study to evaluate the impact of mid and upper facial treatment with hyaluronic acid (HA) fillers and onabotulinumtoxinA (onabotA) on periorbital satisfaction and appearance.
[PATIENTS/METHODS] Eligible participants received ≥ 2 HA fillers (VYC-15L, VYC-17.5L, VYC-20L) in the mid and upper face on Day 1, and VYC-15L in the infraorbital hollow (IOH) on Day 30 if needed. Optional touch ups followed after 14 days. OnabotA was administered to glabellar lines (GL) and/or lateral canthal lines (LCL) on Day 60. The primary endpoint was the change from baseline in FACE-Q Satisfaction with Eyes to Day 90. Additional effectiveness assessments and safety were monitored throughout.
[RESULTS] Enrolled participants were 86.3% White and 13.7% Asian. FACE-Q Rasch-transformed scores increased from baseline to Day 90 by 55.5 points (p < 0.0001). Investigator-assessed infraorbital appearance improved in 69.4% of participants at Day 30 (p = 0.063 vs. baseline) and in 100% at Day 90. Periorbital appearance improved in 91.7% (investigator) and 95.8% (participant) of participants at Day 30, reaching 100% for both at Day 90 (nominal p < 0.0001 vs. baseline). IOH severity gradually decreased, with 59.8% of participants showing minimal or no severity at Day 90 versus 0% at baseline, and infraorbital volume increased. No unexpected safety signals were observed.
[CONCLUSIONS] Combination of HA fillers and onabotA treatments improved eye satisfaction, periorbital and infraorbital appearance, IOH severity, and infraorbital volume, demonstrating direct and indirect treatment effects.
[AIMS] Open-label study to evaluate the impact of mid and upper facial treatment with hyaluronic acid (HA) fillers and onabotulinumtoxinA (onabotA) on periorbital satisfaction and appearance.
[PATIENTS/METHODS] Eligible participants received ≥ 2 HA fillers (VYC-15L, VYC-17.5L, VYC-20L) in the mid and upper face on Day 1, and VYC-15L in the infraorbital hollow (IOH) on Day 30 if needed. Optional touch ups followed after 14 days. OnabotA was administered to glabellar lines (GL) and/or lateral canthal lines (LCL) on Day 60. The primary endpoint was the change from baseline in FACE-Q Satisfaction with Eyes to Day 90. Additional effectiveness assessments and safety were monitored throughout.
[RESULTS] Enrolled participants were 86.3% White and 13.7% Asian. FACE-Q Rasch-transformed scores increased from baseline to Day 90 by 55.5 points (p < 0.0001). Investigator-assessed infraorbital appearance improved in 69.4% of participants at Day 30 (p = 0.063 vs. baseline) and in 100% at Day 90. Periorbital appearance improved in 91.7% (investigator) and 95.8% (participant) of participants at Day 30, reaching 100% for both at Day 90 (nominal p < 0.0001 vs. baseline). IOH severity gradually decreased, with 59.8% of participants showing minimal or no severity at Day 90 versus 0% at baseline, and infraorbital volume increased. No unexpected safety signals were observed.
[CONCLUSIONS] Combination of HA fillers and onabotA treatments improved eye satisfaction, periorbital and infraorbital appearance, IOH severity, and infraorbital volume, demonstrating direct and indirect treatment effects.
추출된 의학 개체 (NER)
| 유형 | 영어 표현 | 한국어 / 풀이 | UMLS CUI | 출처 | 등장 |
|---|---|---|---|---|---|
| 재료 | ha
|
히알루론산 | dict | 3 | |
| 재료 | hyaluronic acid
|
히알루론산 | dict | 2 | |
| 해부 | periorbital
|
scispacy | 1 | ||
| 해부 | upper facial
|
scispacy | 1 | ||
| 해부 | glabellar lines
|
scispacy | 1 | ||
| 해부 | lateral canthal lines
|
scispacy | 1 | ||
| 해부 | LCL
→ lateral canthal lines
|
scispacy | 1 | ||
| 해부 | Eyes
|
scispacy | 1 | ||
| 해부 | infraorbital
|
scispacy | 1 | ||
| 해부 | eye
|
scispacy | 1 | ||
| 합병증 | Periorbital
|
scispacy | 1 | ||
| 약물 | OnabotulinumtoxinA
|
scispacy | 1 | ||
| 약물 | [BACKGROUND]
|
scispacy | 1 | ||
| 약물 | onabotA
→ onabotulinumtoxinA
|
scispacy | 1 | ||
| 약물 | [PATIENTS/METHODS] Eligible
|
scispacy | 1 | ||
| 약물 | [CONCLUSIONS]
|
scispacy | 1 | ||
| 질환 | IOH
→ infraorbital hollow
|
scispacy | 1 | ||
| 기타 | VYC-17.5L
|
scispacy | 1 | ||
| 기타 | participants
|
scispacy | 1 | ||
| 기타 | HA fillers
|
scispacy | 1 |
MeSH Terms
Humans; Hyaluronic Acid; Botulinum Toxins, Type A; Dermal Fillers; Female; Patient Satisfaction; Middle Aged; Cosmetic Techniques; Skin Aging; Adult; Male; Treatment Outcome; Product Surveillance, Postmarketing; Face; Rejuvenation
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