Needless Laser Injector for Antiaging Effect of Dermal Filler

January 12, 2023 updated by: Jung-Won Shin, Seoul National University Bundang Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser-induced microjet injector (Mirajet)
The left/right assignment was sealed in a nontransparent envelop.
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.
Other Names:
  • polylactic acid (PLA)/hyaluronic acid (HA) composite dermal filler
Active Comparator: Needle injection (control)
The left/right assignment was sealed in a nontransparent envelop.
Device: 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.
Other Names:
  • polylactic acid (PLA)/hyaluronic acid (HA) composite dermal filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Skin hydration using a Corneometer® CM 825
Time Frame: at 12 weeks after treatment
at 12 weeks after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Jung Won Shin, M.D., Ph.D., Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Estimate)

January 16, 2023

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIRAJET-KHIDI-2004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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