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Completed

NCT Number: NCT05685667

Needless Laser Injector for Antiaging Effect of Dermal Filler

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

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Key information

Conditions

Aging Problems

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

needless laser injector (Mirajet)

Device

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

needle injection

Device

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

Primary outcomes

  1. Skin hydration using a Corneometer® CM 825

    Time frame: at 12 weeks after treatment

Secondary outcomes

  1. Skin elasticity using a Cutometer® MPA 580

    Time frame: at 12 weeks after treatment

  2. Erythema index (EI) using a Mexameter® MX 18 (Courage & Khazaka)

    Time frame: at 12 weeks after treatment

  3. Skin aging analyzed by three-dimensional photogrammetry

    Time frame: at 12 weeks after treatment

  4. Patient's satisfaction score for antiaging effects

    Time frame: at 12 weeks after treatment

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

  5. Patient's pain score during treatment

    Time frame: up to 24 weeks

    from 0 (none) to 10 (worst)

  6. Adverse events related to the procedure

    Time frame: up to 24 weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 17, 2023
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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