Aging ProblemsNCT05685667
Needless Laser Injector for Antiaging Effect of Dermal Filler
A study testing needless laser injector (Mirajet) and needle injection in people with Aging Problems, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The investigators aimed to evaluate the efficacy and safety of needless laser injector for antiaging effect of dermal filler. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging Problems
- What is being tested?
- needless laser injector (Mirajet) and needle injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who wanted to improve facial skin aging
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, 13620
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging Problems
- Being tested
- needless laser injector (Mirajet), needle injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
needless laser injector (Mirajet)Device
Also called polylactic acid (PLA)/hyaluronic acid (HA) composite dermal filler
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 injectionDevice
Also called polylactic acid (PLA)/hyaluronic acid (HA) composite dermal filler
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.
| Study group | Role | What they receive |
|---|---|---|
| Laser-induced microjet injector (Mirajet) | Experimental | The left/right assignment was sealed in a nontransparent envelop. Receives: Device: needless laser injector (Mirajet) |
| Needle injection (control) | Active comparator | The left/right assignment was sealed in a nontransparent envelop. Receives: Device: needle injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin hydration using a Corneometer® CM 825
Measured: at 12 weeks after treatment
Secondary outcomes (6)
Skin elasticity using a Cutometer® MPA 580
Measured: at 12 weeks after treatment
Erythema index (EI) using a Mexameter® MX 18 (Courage & Khazaka)
Measured: at 12 weeks after treatment
Skin aging analyzed by three-dimensional photogrammetry
Measured: at 12 weeks after treatment
Patient's satisfaction score for antiaging effects
from 1 (extremely dissatisfied) to 7 (extremely satisfied)
Measured: at 12 weeks after treatment
Patient's pain score during treatment
from 0 (none) to 10 (worst)
Measured: up to 24 weeks
Adverse events related to the procedure
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Aug 2021
- Primary completion31 Aug 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aging ProblemsStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Won Shin, Seoul National University Bundang Hospital
- Investigators
- Jung Won Shin, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685667
- Sponsor's protocol ID
- MIRAJET-KHIDI-2004
- Status last verified
- Jan 2023
- First submitted
- 21 Dec 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han HS, Kim BR, Kim M, Na JI, Seo SB, Huh CH, Shin JW. Needleless laser injector versus needle injection for skin enhancement and rejuvenation effect of dermal filler. Lasers Surg Med. 2023 Nov;55(9):809-816. doi: 10.1002/lsm.23719. Epub 2023 Aug 26.
PubMed 37632290
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needless Laser Injector Versus Needle Injection for Antiaging Effect of Dermal Filler: A Randomized Split-face Comparison
- ClinicalTrials.gov ID
- NCT05685667
- Acronym / sponsor ID
- MIRAJET-KHIDI-2004
- Conditions
- Aging Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aimed to evaluate the efficacy and safety of needless laser injector for antiaging effect of dermal filler.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser-induced microjet injector (Mirajet) | Experimental | Device: needless laser injector (Mirajet)The left/right assignment was sealed in a nontransparent envelop. |
| Needle injection (control) | Active comparator | Device: needle injectionThe left/right assignment was sealed in a nontransparent envelop. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients who wanted to improve facial skin aging
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| needless laser injector (Mirajet)Also: polylactic acid (PLA)/hyaluronic acid (HA) composite dermal fillerMirajet 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. | Device | Laser-induced microjet injector (Mirajet) |
| needle injectionAlso: polylactic acid (PLA)/hyaluronic acid (HA) composite dermal fillerFor 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. | Device | Needle injection (control) |
Primary outcome
Skin hydration using a Corneometer® CM 825
Time frame: at 12 weeks after treatment
6 secondary outcomes
Skin elasticity using a Cutometer® MPA 580
Time frame: at 12 weeks after treatment
Erythema index (EI) using a Mexameter® MX 18 (Courage & Khazaka)
Time frame: at 12 weeks after treatment
Skin aging analyzed by three-dimensional photogrammetry
Time frame: at 12 weeks after treatment
Patient's satisfaction score for antiaging effects
Time frame: at 12 weeks after treatment
Patient's pain score during treatment
Time frame: up to 24 weeks
Adverse events related to the procedure
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Derived from this study: PubMed 37632290Han HS, Kim BR, Kim M, Na JI, Seo SB, Huh CH, Shin JW. Needleless laser injector versus needle injection for skin enhancement and rejuvenation effect of dermal filler. Lasers Surg Med. 2023 Nov;55(9):809-816. doi: 10.1002/lsm.23719. Epub 2023 Aug 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Won Shin, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing needless laser injector (Mirajet) and needle injection in people with Aging Problems, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin hydration using a Corneometer® CM 825 (time frame: at 12 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05685667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.