Needless Laser Injector for Antiaging Effect of Dermal Filler

Study Overview
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Brief Summary
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The investigators aimed to evaluate the efficacy and safety of needless laser injector for antiaging effect of dermal filler.

Detailed Description
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A 24-week prospective, single-center, assessor-blinded, randomized, split-face study was conducted to compare the clinical efficacy and safety of needless laser injector versus needle injection for anti-aging effect of dermal filler.

Official Title
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Needless Laser Injector Versus Needle Injection for Antiaging Effect of Dermal Filler: A Randomized Split-face Comparison

Conditions
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Aging Problems

Intervention / Treatment
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* Device: needless laser injector (Mirajet)
* Device: needle injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who wanted to improve facial skin aging Exclusion Criteria: a history of skin rejuvenation treatment (including filler, botulinum toxin, lasers, chemical peeling, and topical retinoid) within 6 month prior to the start of the study having a plan for skin rejuvenation treatment during the study current pregnancy or breastfeeding an allergy to polylactic acid (PLA) or hyaluronic acid (HA) uncontrolled medical diseases

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser-induced microjet injector (Mirajet)<br>The left/right assignment was sealed in a nontransparent envelop. | Device: needless laser injector (Mirajet)<br>* Mirajet injection was performed 2-3 passes until a total of 2cc of diluted PLA/HA solution was completely injected to the one half of the face.<br>* Other names: polylactic acid (PLA)/hyaluronic acid (HA) composite dermal filler;|
| Active Comparator: Needle injection (control)<br>The left/right assignment was sealed in a nontransparent envelop. | Device: needle injection<br>* For traditional method of needle injection, intradermal injection using multi-puncture/micro-papule technique was used. A series of injections at 0.5-1 cm apart was performed on one half of the face so that a total of 2cc of diluted PLA/HA solution was injected.<br>* Other names: polylactic acid (PLA)/hyaluronic acid (HA) composite dermal filler;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin hydration using a Corneometer® CM 825 |  | at 12 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin elasticity using a Cutometer® MPA 580 |  | at 12 weeks after treatment | 
| Erythema index (EI) using a Mexameter® MX 18 (Courage & Khazaka) |  | at 12 weeks after treatment | 
| Skin aging analyzed by three-dimensional photogrammetry |  | at 12 weeks after treatment | 
| Patient's satisfaction score for antiaging effects | from 1 (extremely dissatisfied) to 7 (extremely satisfied) | at 12 weeks after treatment | 
| Patient's pain score during treatment | from 0 (none) to 10 (worst) | up to 24 weeks | 
| Adverse events related to the procedure |  | up to 24 weeks |