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The investigators aimed to evaluate the efficacy and safety of needless laser injector for antiaging effect of dermal filler.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser-induced microjet injector (Mirajet) | Experimental | The left/right assignment was sealed in a nontransparent envelop. |
|
| Needle injection (control) | Active Comparator | The left/right assignment was sealed in a nontransparent envelop. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| needless laser injector (Mirajet) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin hydration using a Corneometer® CM 825 | at 12 weeks after treatment |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung Won Shin, M.D., Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37632290 | Derived | Han HS, Kim BR, Kim M, Na JI, Seo SB, Huh CH, Shin JW. Needleless laser injector versus needle injection for skin enhancement and rejuvenation effect of dermal filler. Lasers Surg Med. 2023 Nov;55(9):809-816. doi: 10.1002/lsm.23719. Epub 2023 Aug 26. |
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| ID | Term |
|---|---|
| D009339 | Needles |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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|
| needle injection | Device | 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. |
|
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| 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 |