Needless Laser Injector for Antiaging Effect of Dermal Filler

Aging Problems Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05685667
• Other study ID #: MIRAJET-KHIDI-2004
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2023
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 1, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging Problems

Intervention

Device:
• needless 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.
• needle 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin hydration using a Corneometer® CM 825		at 12 weeks after treatment
Secondary	Skin elasticity using a Cutometer® MPA 580		at 12 weeks after treatment
Secondary	Erythema index (EI) using a Mexameter® MX 18 (Courage & Khazaka)		at 12 weeks after treatment
Secondary	Skin aging analyzed by three-dimensional photogrammetry		at 12 weeks after treatment
Secondary	Patient's satisfaction score for antiaging effects	from 1 (extremely dissatisfied) to 7 (extremely satisfied)	at 12 weeks after treatment
Secondary	Patient's pain score during treatment	from 0 (none) to 10 (worst)	up to 24 weeks
Secondary	Adverse events related to the procedure		up to 24 weeks