Needless Laser Injector for Antiaging Effect of Dermal Filler
Needless Laser Injector Versus Needle Injection for Antiaging Effect of Dermal Filler: A Randomized Split-face Comparison
1 other identifier
interventional
24
1 country
1
Brief Summary
The investigators aimed to evaluate the efficacy and safety of needless laser injector for antiaging effect of dermal filler.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedFirst Submitted
Initial submission to the registry
December 21, 2022
CompletedFirst Posted
Study publicly available on registry
January 17, 2023
CompletedJanuary 17, 2023
January 1, 2023
1.1 years
December 21, 2022
January 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Skin hydration using a Corneometer® CM 825
at 12 weeks after treatment
Secondary Outcomes (6)
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
Patient's pain score during treatment
up to 24 weeks
- +1 more secondary outcomes
Study Arms (2)
Laser-induced microjet injector (Mirajet)
EXPERIMENTALThe left/right assignment was sealed in a nontransparent envelop.
Needle injection (control)
ACTIVE COMPARATORThe left/right assignment was sealed in a nontransparent envelop.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- patients who wanted to improve facial skin aging
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jung Won Shin, M.D., Ph.D.
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 21, 2022
First Posted
January 17, 2023
Study Start
August 1, 2021
Primary Completion
August 31, 2022
Study Completion
December 1, 2022
Last Updated
January 17, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share