Needless Laser Injector for Antiaging Effect of Dermal Filler

NCT ID: NCT05685667

Last Updated: 2023-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Aging Problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Laser-induced microjet injector (Mirajet)

The left/right assignment was sealed in a nontransparent envelop.

Group Type EXPERIMENTAL

needless laser injector (Mirajet)

Intervention Type 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.

Needle injection (control)

The left/right assignment was sealed in a nontransparent envelop.

Group Type ACTIVE_COMPARATOR

needle injection

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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polylactic acid (PLA)/hyaluronic acid (HA) composite dermal filler polylactic acid (PLA)/hyaluronic acid (HA) composite dermal filler

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Won Shin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung Won Shin, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MIRAJET-KHIDI-2004

Identifier Type: -

Identifier Source: org_study_id

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