Changing in Skin Physiology After Microdroplet Placement of Stabilized Hyaluronic Acid in Aging Faces

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Split-face Study of Changing in Skin Physiology and Clinical Appearance After Microdroplet Placement of Stabilized Hyaluronic Acid in Aging Faces

Conditions
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Aging

Intervention / Treatment
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* Device: Restylane Vital


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy people older than 25 years Exclusion Criteria: known hypersensitivity to HA, an active skin disease, any autoimmune disorder, or significant renal, hepatic, or other medical diseases

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treated side (Restylane vital)<br>We injected staabilized hyaluronic acid (HA)-based gel of nonanimal origin on the left side of face. (We performed split face study) | Device: Restylane Vital<br>* stabilized hyaluronic acid (HA)-based gel of nonanimal origin<br>|
| No Intervention: untreated side (control)<br>We did nothing on the right side of face and we compared the results on same participants | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 12 weeks |