A randomized, split-face, double-blind, comparative study of the safety and efficacy of small- and large-particle hyaluronic acid fillers for the treatment of nasolabial folds
© 2020 Wiley Periodicals LLC..
BACKGROUND: Injections of hyaluronic acid (HA) for tissue augmentation are one of the most common aesthetic treatments performed worldwide. However, few studies have compared the safety and efficacy of small- and large-particle HA (SP-HA; LP-HA).
AIM: To assess and compare the safety and efficacy of SP-HA and LP-HA for the correction of nasolabial folds (NLFs).
METHODS: A prospective, split-face, triple-blind study design was used. Ten female subjects were recruited. Patients underwent treatment at baseline, an optional touch up at Week 2, and a follow-up visit at Week 4. At weeks 2 and 4, a blinded reviewer assessed the patients using the Global Aesthetic Improvement Scale (GAIS) and Wrinkle Severity Rating Scale (WSRS); and subjects completed the Patient Satisfaction Questionnaire (PSQ). At all visits, 3-dimensional imagery and ultrasonography of patients' NLFs were captured. Adverse events (AEs) were evaluated by the Investigator and recorded by subjects in diaries.
RESULTS: The GAIS response rate, defined as ≥ "improved" from baseline, was between 90 (2 weeks) and 100% (1 month) for SP-HA and was 100% for LP-HA, at both visits. Paired-samples t tests revealed significant differences in the change in WSRS scores between groups, at both visits (P < .01). Differences in the clinical effect and lifting capacity of both products were observed in 3-dimensional imagery and ultrasonography. Treatment volumes varied, with 61.32% more SP-HA being required than LP-HA for achieving a ≥ one-grade WSRS improvement. There were no severe AEs throughout the trial, nor AEs related to the investigational device.
CONCLUSIONS: LP-HA demonstrates better efficacy for correcting bony resorption in the nasal pyriform region.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:20 |
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| Enthalten in: |
Journal of cosmetic dermatology - 20(2021), 5 vom: 01. Mai, Seite 1450-1458 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Nikolis, Andreas [VerfasserIn] |
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| Links: |
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| Themen: |
9004-61-9 |
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| Anmerkungen: |
Date Completed 14.05.2021 Date Revised 31.05.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/jocd.13668 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM313542600 |
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| 100 | 1 | |a Nikolis, Andreas |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A randomized, split-face, double-blind, comparative study of the safety and efficacy of small- and large-particle hyaluronic acid fillers for the treatment of nasolabial folds |
| 264 | 1 | |c 2021 | |
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| 500 | |a Date Revised 31.05.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2020 Wiley Periodicals LLC. | ||
| 520 | |a BACKGROUND: Injections of hyaluronic acid (HA) for tissue augmentation are one of the most common aesthetic treatments performed worldwide. However, few studies have compared the safety and efficacy of small- and large-particle HA (SP-HA; LP-HA) | ||
| 520 | |a AIM: To assess and compare the safety and efficacy of SP-HA and LP-HA for the correction of nasolabial folds (NLFs) | ||
| 520 | |a METHODS: A prospective, split-face, triple-blind study design was used. Ten female subjects were recruited. Patients underwent treatment at baseline, an optional touch up at Week 2, and a follow-up visit at Week 4. At weeks 2 and 4, a blinded reviewer assessed the patients using the Global Aesthetic Improvement Scale (GAIS) and Wrinkle Severity Rating Scale (WSRS); and subjects completed the Patient Satisfaction Questionnaire (PSQ). At all visits, 3-dimensional imagery and ultrasonography of patients' NLFs were captured. Adverse events (AEs) were evaluated by the Investigator and recorded by subjects in diaries | ||
| 520 | |a RESULTS: The GAIS response rate, defined as ≥ "improved" from baseline, was between 90 (2 weeks) and 100% (1 month) for SP-HA and was 100% for LP-HA, at both visits. Paired-samples t tests revealed significant differences in the change in WSRS scores between groups, at both visits (P < .01). Differences in the clinical effect and lifting capacity of both products were observed in 3-dimensional imagery and ultrasonography. Treatment volumes varied, with 61.32% more SP-HA being required than LP-HA for achieving a ≥ one-grade WSRS improvement. There were no severe AEs throughout the trial, nor AEs related to the investigational device | ||
| 520 | |a CONCLUSIONS: LP-HA demonstrates better efficacy for correcting bony resorption in the nasal pyriform region | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Agein | |
| 650 | 4 | |a Facial aesthetics | |
| 650 | 4 | |a Rejuvenation | |
| 650 | 4 | |a Skin | |
| 650 | 4 | |a Wrinkles | |
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| 650 | 7 | |a Hyaluronic Acid |2 NLM | |
| 650 | 7 | |a 9004-61-9 |2 NLM | |
| 700 | 1 | |a Enright, Kaitlyn M |e verfasserin |4 aut | |
| 700 | 1 | |a Öhrlund, Åke |e verfasserin |4 aut | |
| 700 | 1 | |a Winlöf, Per |e verfasserin |4 aut | |
| 700 | 1 | |a Cotofana, Sebastian |e verfasserin |4 aut | |
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