Restylane Lyft for Aesthetic Shaping of the Nasal Dorsum and Radix: A Randomized, No-Treatment Control, Multicenter Study.
Abstract
[BACKGROUND] Hyaluronic acid fillers are widely used in nonsurgical rhinoplasty.
[METHODS] The authors performed a no-treatment control, multicenter, 12-month follow-up study to evaluate efficacy and safety of Restylane Lyft (Galderma, Uppsala, Sweden) in shaping the nasal dorsum and radix. Assignment to Restylane Lyft or no-treatment control was randomized (3:1). The Restylane Lyft group received a maximum of 1 ml of Restylane Lyft on day 1; the control group was offered a maximum of 1 ml of Restylane Lyft at month 6. Both groups were offered re-treatment (a maximum of 0.5 ml of Restylane Lyft) at month 12. Outcome assessments included blinded evaluation of three-dimensional photography measurements of change in volume (primary endpoint; month 6) and elevation of the nasal dorsum and radix, aesthetic improvement, adverse events, and diary-reported injection-site reactions.
[RESULTS] One hundred thirty-two Chinese subjects were enrolled. The Restylane Lyft group had a greater increase in volume of the nasal dorsum and radix than the no-treatment control (mean difference at month 6, 0.71 ml; 95 percent confidence interval, 0.59 to 0.83 ml; p < 0.001). Restylane Lyft was also more effective than no-treatment control in achieving an elevation of the nasal dorsum and radix. The increase in volume and elevation persisted up to 12 months after injection and was supported by clinical assessments of aesthetic improvement. Treatment-related adverse events were mild to moderate, nonserious, and resolved during the study. Injection-site reactions were mostly mild to moderate and resolved within 1 week.
[CONCLUSION] Restylane Lyft injection was effective for aesthetic shaping of the nasal dorsum and radix and achieved aesthetic improvement for up to 12 months with an acceptable safety profile.
[CLINICAL QUESTION/LEVEL OF EVIDENCE] Therapeutic, I.
[METHODS] The authors performed a no-treatment control, multicenter, 12-month follow-up study to evaluate efficacy and safety of Restylane Lyft (Galderma, Uppsala, Sweden) in shaping the nasal dorsum and radix. Assignment to Restylane Lyft or no-treatment control was randomized (3:1). The Restylane Lyft group received a maximum of 1 ml of Restylane Lyft on day 1; the control group was offered a maximum of 1 ml of Restylane Lyft at month 6. Both groups were offered re-treatment (a maximum of 0.5 ml of Restylane Lyft) at month 12. Outcome assessments included blinded evaluation of three-dimensional photography measurements of change in volume (primary endpoint; month 6) and elevation of the nasal dorsum and radix, aesthetic improvement, adverse events, and diary-reported injection-site reactions.
[RESULTS] One hundred thirty-two Chinese subjects were enrolled. The Restylane Lyft group had a greater increase in volume of the nasal dorsum and radix than the no-treatment control (mean difference at month 6, 0.71 ml; 95 percent confidence interval, 0.59 to 0.83 ml; p < 0.001). Restylane Lyft was also more effective than no-treatment control in achieving an elevation of the nasal dorsum and radix. The increase in volume and elevation persisted up to 12 months after injection and was supported by clinical assessments of aesthetic improvement. Treatment-related adverse events were mild to moderate, nonserious, and resolved during the study. Injection-site reactions were mostly mild to moderate and resolved within 1 week.
[CONCLUSION] Restylane Lyft injection was effective for aesthetic shaping of the nasal dorsum and radix and achieved aesthetic improvement for up to 12 months with an acceptable safety profile.
[CLINICAL QUESTION/LEVEL OF EVIDENCE] Therapeutic, I.
추출된 의학 개체 (NER)
| 유형 | 영어 표현 | 한국어 / 풀이 | UMLS CUI | 출처 | 등장 |
|---|---|---|---|---|---|
| 해부 | nasal dorsum
|
콧등 | dict | 6 | |
| 시술 | rhinoplasty
|
코성형술 | dict | 1 | |
| 재료 | hyaluronic acid
|
히알루론산 | dict | 1 | |
| 약물 | Restylane
|
C1101698
Restylane
|
scispacy | 1 | |
| 약물 | Galderma
|
scispacy | 1 | ||
| 약물 | [BACKGROUND] Hyaluronic acid
|
scispacy | 1 | ||
| 약물 | [RESULTS] One hundred thirty-two
|
scispacy | 1 | ||
| 질환 | diary-reported injection-site reactions
|
scispacy | 1 | ||
| 질환 | radix
|
C0242726
Plant Roots
|
scispacy | 1 | |
| 기타 | Galderma
|
scispacy | 1 | ||
| 기타 | Uppsala
|
scispacy | 1 | ||
| 기타 | subjects
|
scispacy | 1 |
MeSH Terms
Humans; Hyaluronic Acid; Cosmetic Techniques; Follow-Up Studies; Esthetics; Injection Site Reaction
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