Hyamax® Monophasic Volumizer Dermal Fillers for Chin Restoration: A Prospective, Single-Center, Investigator-Blinded, Randomized Controlled Trial.
Abstract
[BACKGROUND] Hyamax® Monophasic Volumizer Dermal Fillers is a newly designed hyaluronic acid soft tissue filler for chin augmentation.
[METHODS] A prospective, single-center, evaluator-blinded, randomized controlled study was designed to evaluate the effectiveness and safety of Hyamax® Volumizer in the correction of chin retrusion in the 18-55-year-old Chinese population for 12 months after treatment. Participants were randomized (3:1) to receive Hyamax® Volumizer injection (n = 21) or no treatment (n = 7). Assessments included live and blinded evaluations by photographs on a chin retrusion scale (Galderma Chin Retrusion Scale), aesthetic improvement (Global Aesthetic Improvement Scale) by the subjects and independent evaluators, and safety follow-up at 3, 6, 9, and 12 months.
[RESULTS] Hyamax® Volumizer was superior in improving chin retrusion at 6 months with a GCRS response rate of 57.14% versus 0% of the controls (P<0.0001) meeting the primary effectiveness objective. The GCRS and GAIS scores by subjects and evaluators achieved remarkable improvement at all follow-up points compared with the control group through 12 months. Common ISRs were injection-site pain (90.48%), tenderness (80.95%), redness (47.62%) and ecchymosis (19.05%). No serious treatment-related advert events were reported.
[CONCLUSION] Hyamax® Volumizer significantly restored the facial volume and improved the chin projection with safety.
[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 .
[METHODS] A prospective, single-center, evaluator-blinded, randomized controlled study was designed to evaluate the effectiveness and safety of Hyamax® Volumizer in the correction of chin retrusion in the 18-55-year-old Chinese population for 12 months after treatment. Participants were randomized (3:1) to receive Hyamax® Volumizer injection (n = 21) or no treatment (n = 7). Assessments included live and blinded evaluations by photographs on a chin retrusion scale (Galderma Chin Retrusion Scale), aesthetic improvement (Global Aesthetic Improvement Scale) by the subjects and independent evaluators, and safety follow-up at 3, 6, 9, and 12 months.
[RESULTS] Hyamax® Volumizer was superior in improving chin retrusion at 6 months with a GCRS response rate of 57.14% versus 0% of the controls (P<0.0001) meeting the primary effectiveness objective. The GCRS and GAIS scores by subjects and evaluators achieved remarkable improvement at all follow-up points compared with the control group through 12 months. Common ISRs were injection-site pain (90.48%), tenderness (80.95%), redness (47.62%) and ecchymosis (19.05%). No serious treatment-related advert events were reported.
[CONCLUSION] Hyamax® Volumizer significantly restored the facial volume and improved the chin projection with safety.
[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 .
추출된 의학 개체 (NER)
| 유형 | 영어 표현 | 한국어 / 풀이 | UMLS CUI | 출처 | 등장 |
|---|---|---|---|---|---|
| 시술 | chin augmentation
|
턱끝성형술 | dict | 1 | |
| 시술 | soft tissue filler
|
필러 주입술 | dict | 1 | |
| 해부 | chin
|
scispacy | 1 | ||
| 합병증 | chin retrusion
|
scispacy | 1 | ||
| 합병증 | facial
|
scispacy | 1 | ||
| 재료 | hyaluronic acid
|
히알루론산 | dict | 1 | |
| 약물 | Investigator-Blinded
|
scispacy | 1 | ||
| 약물 | GCRS
|
scispacy | 1 | ||
| 약물 | [BACKGROUND] Hyamax
|
scispacy | 1 | ||
| 질환 | injection-site pain
|
scispacy | 1 | ||
| 질환 | tenderness
|
C0234233
Sore to touch
|
scispacy | 1 | |
| 질환 | redness
|
C0041834
Erythema
|
scispacy | 1 | |
| 질환 | ecchymosis
|
C0013491
Ecchymosis
|
scispacy | 1 |
MeSH Terms
Humans; Dermal Fillers; Hyaluronic Acid; Prospective Studies; Adult; Female; Chin; Middle Aged; Male; Single-Blind Method; Young Adult; Adolescent; Cosmetic Techniques; Treatment Outcome; Esthetics; Follow-Up Studies; Skin Aging; Rejuvenation
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