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IMPORTANCE Skin rejuvenation can be achieved effectively and safely by injection of a stabilized hyaluronic acid (HA)-based gel of nonanimal origin (NASHA) injection using a stamp-type electronic multineedle injector.
OBJECTIVE To determine the efficacy and safety of NASHA using a stamp-type electronic multineedle injector, and if changes in skin physiology occur earlier than in previous trials.
DESIGN, SETTING, AND PARTICIPANTS Twenty-five patients were recruited to this single-center, evaluator-blinded, prospective, balanced (1:1), split-face randomized clinical trial.One dermatologist who was blinded as to the treatment side evaluated the skin hydration, melanin content, erythema, and elasticity of both cheeks using a corneometer, a mexameter, and a reviscometer, respectively, at each follow-up visit (0, 1, 2, 4, 8, and 12 weeks postinjection). The subjects and two independent investigators assessed the clinical improvement using the Global Aesthetic Improvement Scale (GAIS) at the every visit. Twenty-four participants completed the study, and no participants withdrew due to adverse effects.
INTERVENTIONS Each participant submitted to a single treatment with a NASHA injection to one side of the lower cheek. The cheek side to which the treatment was applied was chosen randomly.
Twenty-five patients were recruited to this single-center, evaluator-blinded, prospective, balanced (1:1), split-face randomized clinical trial. Twenty-four participants completed the study, and no participants withdrew due to adverse effects. Each participant submitted to a single treatment with a NASHA injection to one side of the lower cheek. One dermatologist who was blinded as to the treatment side evaluated the skin hydration, melanin content, erythema, and elasticity of both cheeks using a corneometer, a mexameter, and a reviscometer, respectively, at each follow-up visit (0, 1, 2, 4, 8, and 12 weeks postinjection). The subjects and two independent investigators assessed the clinical improvement using the Global Aesthetic Improvement Scale (GAIS) at the every visit. Adverse events were self-reported by the patients completing a questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treated side (Restylane vital) | Experimental | We injected staabilized hyaluronic acid (HA)-based gel of nonanimal origin on the left side of face. (We performed split face study) |
|
| untreated side (control) | No Intervention | We did nothing on the right side of face and we compared the results on same participants |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Vital | Device | stabilized hyaluronic acid (HA)-based gel of nonanimal origin |
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| Measure | Description | Time Frame |
|---|---|---|
| Hydration Level | We measured a hydration level by a corneometer device (Courage & Khazaka, Cologne, Germany). The range of hydration level was 0 (as dry as possible) ~120 AU (Arbitrary Unit)(most moist possible) | 12 weeks |
| Elasticity | We measured a elasticity by a reviscometer device (Courage & Khazaka, Cologne, Germany). The range of elasticity was 0 (most elastic possible as) ~400 AU(Arbitrary Unit) (inelastic as possible) | 12 weeks |
| Melanin Index | We measured a melanin index by a mexameter device (Courage & Khazaka, Cologne, Germany). The range of melanin index was 0 (as bright as possible) ~999 AU (Arbitrary Unit) (most dark possible). | 12 weeks |
| Erythema Index | We measured an erythema index by a mexameter device (Courage & Khazaka, Cologne, Germany). The range of erythema index is 0~999 AU(Arbitrary Unit). The range of erythema index was 0 (as non-erythematous as possible) ~999 AU (most erythematous possible) | 12 weeks |
| Global Aesthetic Improvement Scale (Investigator) | The therapeutic outcome was assessed by investigator using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse. | 12 weeks |
| Global Aesthetic Improvement Scale (Subject) | The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yang Won Lee, MD, PhD | Department of Dermatology, Konkuk University School of Medicine, Seoul, Korea | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9856828 | Background | Gniadecka M, Nielsen OF, Wessel S, Heidenheim M, Christensen DH, Wulf HC. Water and protein structure in photoaged and chronically aged skin. J Invest Dermatol. 1998 Dec;111(6):1129-33. doi: 10.1046/j.1523-1747.1998.00430.x. | |
| 16531934 | Background | Matarasso SL, Carruthers JD, Jewell ML; Restylane Consensus Group. Consensus recommendations for soft-tissue augmentation with nonanimal stabilized hyaluronic acid (Restylane). Plast Reconstr Surg. 2006 Mar;117(3 Suppl):3S-34S. doi: 10.1097/01.prs.0000204759.76865.39. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Vital | stabilized hyaluronic acid (HA)-based gel of nonanimal origin Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Vital | stabilized hyaluronic acid (HA)-based gel of nonanimal origin Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hydration Level | We measured a hydration level by a corneometer device (Courage & Khazaka, Cologne, Germany). The range of hydration level was 0 (as dry as possible) ~120 AU (Arbitrary Unit)(most moist possible) | Posted | Mean | Standard Deviation | AU (arbitrary unit) | 12 weeks |
|
12weeks
Adverse events were self-reported by the patients completing a questionnaire.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Restylane Vital | stabilized hyaluronic acid (HA)-based gel of nonanimal origin Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment | Erythema developed right after the treatment and maintained until 5days after the treatment |
First, it did not have a double-blind design, and so the GAIS scores of the subjects could have been influenced. Second, the posttreatment follow-up period was relatively short, at 12 weeks. Finally, the patient sample in this study was small.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yang Won Lee | Konkuk University | 8220305172 | 20130112@kuh.ac.kr |
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| 12 weeks |
| 18384619 | Background | Kerscher M, Bayrhammer J, Reuther T. Rejuvenating influence of a stabilized hyaluronic acid-based gel of nonanimal origin on facial skin aging. Dermatol Surg. 2008 May;34(5):720-6. doi: 10.1111/j.1524-4725.2008.34176.x. Epub 2008 Apr 1. |
| 24002145 | Background | Streker M, Reuther T, Krueger N, Kerscher M. Stabilized hyaluronic acid-based gel of non-animal origin for skin rejuvenation: face, hand, and decolletage. J Drugs Dermatol. 2013 Sep;12(9):990-4. |
| 21612880 | Background | Naylor EC, Watson RE, Sherratt MJ. Molecular aspects of skin ageing. Maturitas. 2011 Jul;69(3):249-56. doi: 10.1016/j.maturitas.2011.04.011. Epub 2011 May 25. |
| 19207331 | Background | Distante F, Pagani V, Bonfigli A. Stabilized hyaluronic acid of non-animal origin for rejuvenating the skin of the upper arm. Dermatol Surg. 2009 Feb;35 Suppl 1:389-93; discussion 394. doi: 10.1111/j.1524-4725.2008.01051.x. No abstract available. |
| 19735521 | Background | Williams S, Tamburic S, Stensvik H, Weber M. Changes in skin physiology and clinical appearance after microdroplet placement of hyaluronic acid in aging hands. J Cosmet Dermatol. 2009 Sep;8(3):216-25. doi: 10.1111/j.1473-2165.2009.00447.x. |
| 19730872 | Background | Reuther T, Bayrhammer J, Kerscher M. Effects of a three-session skin rejuvenation treatment using stabilized hyaluronic acid-based gel of non-animal origin on skin elasticity: a pilot study. Arch Dermatol Res. 2010 Jan;302(1):37-45. doi: 10.1007/s00403-009-0988-9. |
| 21699363 | Background | Ribe A, Ribe N. Neck skin rejuvenation: histological and clinical changes after combined therapy with a fractional non-ablative laser and stabilized hyaluronic acid-based gel of non-animal origin. J Cosmet Laser Ther. 2011 Aug;13(4):154-61. doi: 10.3109/14764172.2011.594060. Epub 2011 Jun 23. |
| 18330796 | Background | Tezel A, Fredrickson GH. The science of hyaluronic acid dermal fillers. J Cosmet Laser Ther. 2008 Mar;10(1):35-42. doi: 10.1080/14764170701774901. |
| 17309996 | Background | Wang F, Garza LA, Kang S, Varani J, Orringer JS, Fisher GJ, Voorhees JJ. In vivo stimulation of de novo collagen production caused by cross-linked hyaluronic acid dermal filler injections in photodamaged human skin. Arch Dermatol. 2007 Feb;143(2):155-63. doi: 10.1001/archderm.143.2.155. |
| 24919799 | Background | Alam M, Han S, Pongprutthipan M, Disphanurat W, Kakar R, Nodzenski M, Pace N, Kim N, Yoo S, Veledar E, Poon E, West DP. Efficacy of a needling device for the treatment of acne scars: a randomized clinical trial. JAMA Dermatol. 2014 Aug;150(8):844-9. doi: 10.1001/jamadermatol.2013.8687. |
| 21342311 | Background | Kim SE, Lee JH, Kwon HB, Ahn BJ, Lee AY. Greater collagen deposition with the microneedle therapy system than with intense pulsed light. Dermatol Surg. 2011 Mar;37(3):336-41. doi: 10.1111/j.1524-4725.2011.01882.x. Epub 2011 Feb 22. |
| 24245880 | Background | Lim HK, Suh DH, Lee SJ, Shin MK. Rejuvenation effects of hyaluronic acid injection on nasojugal groove: prospective randomized split face clinical controlled study. J Cosmet Laser Ther. 2014 Jan;16(1):32-6. doi: 10.3109/14764172.2013.854620. Epub 2013 Nov 19. |
| 19807757 | Background | Bachmann F, Erdmann R, Hartmann V, Wiest L, Rzany B. The spectrum of adverse reactions after treatment with injectable fillers in the glabellar region: results from the Injectable Filler Safety Study. Dermatol Surg. 2009 Oct;35 Suppl 2:1629-34. doi: 10.1111/j.1524-4725.2009.01341.x. |
| 21896135 | Background | Kassir R, Kolluru A, Kassir M. Extensive necrosis after injection of hyaluronic acid filler: case report and review of the literature. J Cosmet Dermatol. 2011 Sep;10(3):224-31. doi: 10.1111/j.1473-2165.2011.00562.x. |
| 26910661 | Derived | Roh NK, Kim MJ, Lee YW, Choe YB, Ahn KJ. A Split-Face Study of the Effects of a Stabilized Hyaluronic Acid-Based Gel of Nonanimal Origin for Facial Skin Rejuvenation Using a Stamp-Type Multineedle Injector: A Randomized Clinical Trial. Plast Reconstr Surg. 2016 Mar;137(3):809-816. doi: 10.1097/01.prs.0000480686.68275.60. |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| hydration | We measured a hydration level by a combination corneometer/mexameter/reviscometer device (Courage & Khazaka, Cologne, Germany). The range of hydration level was 0~120 AU(Arbitrary Unit). < 30 : Very dry, 30~49 : Dry, 50~59: Moisturized, >60 : Sufficiently Moisturized | Mean | Standard Deviation | AU (Arbitrary Unit) |
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| elasticity | We measured a elasticity by a combination corneometer/mexameter/reviscometer device (Courage & Khazaka, Cologne, Germany). The range of elasticity is 0~400 AU(Arbitrary Unit). The lower revisometer values reflect higher elasticity. | Mean | Standard Deviation | AU (arbitrary unit) |
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| melanin index | We measured a melanin index by a combination corneometer/mexameter/reviscometer device (Courage & Khazaka, Cologne, Germany). The range of melamin index is 0~999 AU(Arbitrary Unit). 0~49: Phototype I (celtic type), 50~99 : Phototype II (Caucasian type), 100~149 : Phototype III (European mixed type), 150~199 : Phototype IV (Mediterranean type), 200~299 : Phototype V (Asian/Indian type), 300~999 : Phototype VI (Black skin type) (This is only an approach. It is recommend that each user should develop an own interpretation scale.) | Mean | Standard Deviation | AU(arbitrary unit) |
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| erythema index | We measured a erythema index by a combination corneometer/mexameter/reviscometer device (Courage & Khazaka, Cologne, Germany). The range of erythema index is 0~999 AU(Arbitrary Unit). The lower erythema indices than baseline reflect improvement of erythema. | Mean | Standard Deviation | AU(arbitrary unit) |
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| Primary | Elasticity | We measured a elasticity by a reviscometer device (Courage & Khazaka, Cologne, Germany). The range of elasticity was 0 (most elastic possible as) ~400 AU(Arbitrary Unit) (inelastic as possible) | Posted | Mean | Standard Deviation | AU (arbitrary unit) | 12 weeks |
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| Primary | Melanin Index | We measured a melanin index by a mexameter device (Courage & Khazaka, Cologne, Germany). The range of melanin index was 0 (as bright as possible) ~999 AU (Arbitrary Unit) (most dark possible). | Posted | Mean | Standard Deviation | AU (arbitrary unit) | 12 weeks |
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| Primary | Erythema Index | We measured an erythema index by a mexameter device (Courage & Khazaka, Cologne, Germany). The range of erythema index is 0~999 AU(Arbitrary Unit). The range of erythema index was 0 (as non-erythematous as possible) ~999 AU (most erythematous possible) | Posted | Mean | Standard Deviation | AU (arbitrary unit) | 12 weeks |
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| Primary | Global Aesthetic Improvement Scale (Investigator) | The therapeutic outcome was assessed by investigator using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse. | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks |
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| Primary | Global Aesthetic Improvement Scale (Subject) | The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse | Posted | Mean | Standard Deviation | scores on a scale | 12 weeks |
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