Aging Problems
Conditions
Brief summary
The investigators aimed to evaluate the efficacy and safety of needless laser injector for antiaging effect of dermal filler.
Detailed description
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.
Interventions
DEVICEneedless laser injector (Mirajet)
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.
DEVICEneedle injection
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.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin hydration using a Corneometer® CM 825 | at 12 weeks after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | at 12 weeks after treatment | from 1 (extremely dissatisfied) to 7 (extremely satisfied) |
| Patient's pain score during treatment | up to 24 weeks | from 0 (none) to 10 (worst) |
| Adverse events related to the procedure | up to 24 weeks | — |
Countries
South Korea
Outcome results
None listed