Needless Laser Injector for Antiaging Effect of Dermal Filler

Not Applicable

Completed

• Conditions: Aging Problems
• Interventions: Device: needless laser injector (Mirajet); Device: needle injection

• Registration Number: NCT05685667
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-12-01
• Study First Submitted: 2022-12-21
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-12
• Last Update Submitted: 2023-01-12
• Study First Posted: 2023-01-17
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser-induced microjet injector (Mirajet)	needless laser injector (Mirajet)	The left/right assignment was sealed in a nontransparent envelop.
Needle injection (control)	needle injection	The left/right assignment was sealed in a nontransparent envelop.

Primary Outcome Measures

Name	Time	Method
Skin hydration using a Corneometer® CM 825	at 12 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
Patient's pain score during treatment	up to 24 weeks	from 0 (none) to 10 (worst)
Skin elasticity using a Cutometer® MPA 580	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)
Erythema index (EI) using a Mexameter® MX 18 (Courage & Khazaka)	at 12 weeks after treatment
Adverse events related to the procedure	up to 24 weeks

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of