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Needless Laser Injector for Antiaging Effect of Dermal Filler

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05685667
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
16
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: needless laser injector (Mirajet)
  • Device: needle injection
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Needless Laser Injector Versus Needle Injection for Antiaging Effect of Dermal Filler: A Randomized Split-face Comparison
Actual Study Start Date :
Aug 1, 2021
Actual Primary Completion Date :
Aug 31, 2022
Actual Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Skin hydration using a Corneometer® CM 825 [at 12 weeks after treatment]

    Secondary Outcome Measures

    1. Skin elasticity using a Cutometer® MPA 580 [at 12 weeks after treatment]

    2. Erythema index (EI) using a Mexameter® MX 18 (Courage & Khazaka) [at 12 weeks after treatment]

    3. Skin aging analyzed by three-dimensional photogrammetry [at 12 weeks after treatment]

    4. Patient's satisfaction score for antiaging effects [at 12 weeks after treatment]

      from 1 (extremely dissatisfied) to 7 (extremely satisfied)

    5. Patient's pain score during treatment [up to 24 weeks]

      from 0 (none) to 10 (worst)

    6. Adverse events related to the procedure [up to 24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam Korea, Republic of 13620

    Sponsors and Collaborators

    • Seoul National University Bundang Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jung-Won Shin, Associate Professor, Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT05685667
    Other Study ID Numbers:
    • MIRAJET-KHIDI-2004
    First Posted:
    Jan 17, 2023
    Last Update Posted:
    Jan 17, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hyaluronic Acid

    Study Results

    No Results Posted as of Jan 17, 2023