WrinkleNCT03739398

A Study on the Effectiveness and Safety Evaluation of Combination Therapy With 1,927nm Thulium Laser and Fractional Microneedle Radiofrequency Equipment for Improvement of Skin Aging

A study testing LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR)) and LASEMED laser(The Thulium laser with 1,927nm wavelength) in people with Wrinkle, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Fractional Microneedle Radiofrequency (FMR) equipment is a device that penetrates the epidermis and irradiates the high frequency by entering the dermis. The generated radiofrequency transfers heat energy and induces thermal denaturation in the surrounding tissue. Read more about this study

Who is it for?: Ages 45 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Wrinkle
What is being tested?: LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR)) and LASEMED laser(The Thulium laser with 1,927nm wavelength)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteSouth Korea
Study dates: 24 Aug 2018to 23 Apr 2019
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 45 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy normal adults between 45 and 65 years of age
Subjects with moderate to severe wrinkles based on the Investigator's global assessment of lateral canthal line severity rating
Subjects who have voluntarily signed a written consent before
Subjects who can follow up during the trial
Subjects who have agreed to cease all dermatological treatment or treatment, including improvement of neck and face wrinkles, during this trial

Who cannot join

If subjects do not want it or do not fill out a consent form
If subjects are allergic to local anesthetics (lidocaine)
Subjects who are Pregnant or lactating
Subjects who are deemed to be inadequate as subjects by the clinical investigator for the following patients or other pathologies 1) If the site of treatment has infectious or inflammatory skin disease 2) If the site of treatment has melasma or other pigmented dermatologic disease 3) If subjects have keloid disease, collagen, or elastic fiber disease 4) If subjects have chronic wasting disease (asthma, diabetes, etc.) 5) If subjects are taking anticoagulants and are at risk of bleeding 6) If subjects have an autoimmune disease 7) Subjects with psychiatric problems 8) Acute patients
Others in addition to the above items, if it is deemed difficult for clinical practice to be conducted at the discretion of the clinical trial manager (including illiteracy and other foreigners exclusion)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine
Seoul, 03722

Other trials in South Korea

About this study

Read the detailed description

Using this principle, FMR equipment is being used as a very effective treatment for scarring, enlarged pores, hyperhidrosis as well as wrinkles. Unlike conventional treatments, FMR equipment has the advantage of a short recovery time after treatment because it minimizes damage to the epidermis because the insulated microspheres penetrate the skin and generate high frequency only at the end of the microspheres.

The Thulium laser with 1,927nm wavelength is a device that effectively removes various skin diseases present in the epidermis while minimizing the side effects such as scarring and pigmentation because it induces thermal damage to the only skin surface compared to conventional laser equipment. In recent years, not only skin lesions on the epidermis but also pigment disease and wrinkles have been reported to have a good effect.

In this study, investigator investigated the effect and stability of combined treatment of Thulium laser with 1,927nm wavelength in addition to FMR equipment which has already proven to be effective in improving skin aging.

Conditions: Wrinkle
Being tested: LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR)), LASEMED laser(The Thulium laser with 1,927nm wavelength)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR))Device
1. LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR)) : Fractional Microneedle Radiofrequency (FMR) equipment is a device that penetrates the epidermis and irradiates the high frequency by entering the dermis. The generated radiofrequency transfers heat energy and induces thermal denaturation in the surrounding tissue. Using this principle, FMR equipment is being used as a very effective treatment for scarring, enlarged pores, hyperhidrosis as well as wrinkles. Unlike conventional treatments, FMR equipment has the advantage of a short recovery time after treatment because it minimizes damage to the epidermis because the insulated microspheres penetrate the skin and generate high frequency only at the end of the microspheres.
LASEMED laser(The Thulium laser with 1,927nm wavelength)Device
1. LASEMD laser(The Thulium laser with 1,927nm wavelength) The Thulium laser with 1,927nm wavelength is a device that effectively removes various skin diseases present in the epidermis while minimizing the side effects such as scarring and pigmentation because it induces thermal damage to the only skin surface compared to conventional laser equipment. In recent years, not only skin lesions on the epidermis but also pigment disease and wrinkles have been reported to have a good effect.
In this study, we investigated the effect and stability of combined treatment of Thulium laser with 1,927nm wavelength in addition to FMR equipment which has already proven to be effective in improving skin aging.

Study groups in NCT03739398
Study group	Role	What they receive
LUTRONIC GENUS laser with LASEMD laser	Experimental	Not described Receives: Device: LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR))
LUTRONIC GENUS laser without LASEMD laser	Active comparator	Not described Receives: Device: LASEMED laser(The Thulium laser with 1,927nm wavelength)

What is being measured

The primary outcome is the main question the study is designed to answer.

Skin roughness
The roughness and wrinkle of the skin corresponding to the wrinkles of the outer eyelid
Measured: immediately before the procedure to three months after last procedure
wrinkle
the wrinkle of glabella were measured using an Antera 3D camera and compared
Measured: immediately before the procedure to three months after last procedure

Secondary outcomes (5)

Transepidermal water loss
Measured: immediately before the procedure to three months after last procedure
Description of overall manifestation by clinical photo and visiometer
pigmentation, erythema, scaliness will be checked by photo and visiometer
Measured: immediately before the procedure to three months after last procedure
Patients' subjective Treatment Satisfaction of the degree of skin aging improvement, wrinkles, pores, skin color, skin elasticity, skin dryness
(0 : Not satisfied, 1 : Somewhat satisfied, 2 : Satisfied, 3: Very satisfied)
Measured: immediately before the procedure to three months after last procedure
Evaluation of researchers' skin improvement
(0 : Not improved, 1 : 1 ~ 25% improvement, 2 : 26 ~ 50% improvement, 3: 51 ~ 75% improvement, 4: More than 76% improvement)
Measured: immediately before the procedure to three months after last procedure
Change of investigator's global assessment of lateral canthal line severity rating
( 0: Absent, 1: minimal, 2 : mild, 3: moderate, 4: severe)
Measured: immediately before the procedure to three months after last procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 201823 Apr 2019

First posted13 Nov 2018
Study start24 Aug 2018
Primary completion23 Apr 2019
Study completion23 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for WrinkleStudies of the same condition, open and under way.
More trials run by Yonsei UniversityThe 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: Non-randomised
Intervention model: Parallel groups
Model description: LUTRONIC GENIUS Laser is performed on one side and LASEMD Laser is performed on the other. LUTRONIC GENIUS Laser is performed on the other side without energy irradiation. Laser treatment is performed after application of EMLA cream (2.5% lidocaine 2.5% and prilocaine 2.5%) for 30 minutes or more before local anesthesia. Measurement of hydration, transepidermal water loss, skin pigmentation, redness, and elasticity were performed using a corneometer, a vapometer, a mexameter, and a cutometer before the procedure and on the 7th day after the first operation and 3 months after the last operation. Using an Antera 3D® camera, the skin texture, wrinkles, pores, volume of depressions / elevations, skin color, redness and pigmentation were measured. The change of skin surface and extent of wrinkle were measured using a visuometer, a high-resolution camera.
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03739398
Sponsor's protocol ID: 1-2018-0045
Status last verified: Sep 2020
First submitted: 30 Oct 2018
Last updated: 29 Sep 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Wrinkle trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study on the Effectiveness and Safety Evaluation of Combination Therapy With 1,927nm Thulium Laser and Fractional Microneedle Radiofrequency Equipment for Improvement of Skin Aging
ClinicalTrials.gov ID: NCT03739398
Acronym / sponsor ID: 1-2018-0045
Conditions: Wrinkle
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Yonsei UniversityUniversity, hospital or other
Study start: 24 Aug 2018 (actual)
Primary completion: 23 Apr 2019 (actual)
Study completion: 23 Apr 2019 (actual)
First posted: 13 Nov 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: LUTRONIC GENIUS Laser is performed on one side and LASEMD Laser is performed on the other. LUTRONIC GENIUS Laser is performed on the other side without energy irradiation. Laser treatment is performed after application of EMLA cream (2.5% lidocaine 2.5% and prilocaine 2.5%) for 30 minutes or more before local anesthesia. Measurement of hydration, transepidermal water loss, skin pigmentation, redness, and elasticity were performed using a corneometer, a vapometer, a mexameter, and a cutometer before the procedure and on the 7th day after the first operation and 3 months after the last operation. Using an Antera 3D® camera, the skin texture, wrinkles, pores, volume of depressions / elevations, skin color, redness and pigmentation were measured. The change of skin surface and extent of wrinkle were measured using a visuometer, a high-resolution camera.

Arm	Type	Receives
LUTRONIC GENUS laser with LASEMD laser	Experimental	Device: LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR))
LUTRONIC GENUS laser without LASEMD laser	Active comparator	Device: LASEMED laser(The Thulium laser with 1,927nm wavelength)

Who may qualify

Ages: 45 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Healthy normal adults between 45 and 65 years of age
Subjects with moderate to severe wrinkles based on the Investigator's global assessment of lateral canthal line severity rating
Subjects who have voluntarily signed a written consent before
Subjects who can follow up during the trial
Subjects who have agreed to cease all dermatological treatment or treatment, including improvement of neck and face wrinkles, during this trial

Key exclusion criteria (5 listed)

If subjects do not want it or do not fill out a consent form
If subjects are allergic to local anesthetics (lidocaine)
Subjects who are Pregnant or lactating
Subjects who are deemed to be inadequate as subjects by the clinical investigator for the following patients or other pathologies 1) If the site of treatment has infectious or inflammatory skin disease 2) If the site of treatment has melasma or other pigmented dermatologic disease 3) If subjects have keloid disease, collagen, or elastic fiber disease 4) If subjects have chronic wasting disease (asthma, diabetes, etc.) 5) If subjects are taking anticoagulants and are at risk of bleeding 6) If subjects have an autoimmune disease 7) Subjects with psychiatric problems 8) Acute patients
Others in addition to the above items, if it is deemed difficult for clinical practice to be conducted at the discretion of the clinical trial manager (including illiteracy and other foreigners exclusion)

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
LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR))1. LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR)) : Fractional Microneedle Radiofrequency (FMR) equipment is a device that penetrates the epidermis and irradiates the high frequency by entering the dermis. The generated radiofrequency transfers heat energy and induces thermal denaturation in the surrounding tissue. Using this principle, FMR equipment is being used as a very effective treatment for scarring, enlarged pores, hyperhidrosis as well as wrinkles. Unlike conventional treatments, FMR equipment has the advantage of a short recovery time after treatment because it minimizes damage to the epidermis because the insulated microspheres penetrate the skin and generate high frequency only at the end of the microspheres.	Device	LUTRONIC GENUS laser with LASEMD laser
LASEMED laser(The Thulium laser with 1,927nm wavelength)2. LASEMD laser(The Thulium laser with 1,927nm wavelength) The Thulium laser with 1,927nm wavelength is a device that effectively removes various skin diseases present in the epidermis while minimizing the side effects such as scarring and pigmentation because it induces thermal damage to the only skin surface compared to conventional laser equipment. In recent years, not only skin lesions on the epidermis but also pigment disease and wrinkles have been reported to have a good effect. In this study, we investigated the effect and stability of combined treatment of Thulium laser with 1,927nm wavelength in addition to FMR equipment which has already proven to be effective in improving skin aging.	Device	LUTRONIC GENUS laser without LASEMD laser

Primary outcome

Skin roughness
Time frame: immediately before the procedure to three months after last procedure
The roughness and wrinkle of the skin corresponding to the wrinkles of the outer eyelid
wrinkle
Time frame: immediately before the procedure to three months after last procedure
the wrinkle of glabella were measured using an Antera 3D camera and compared

5 secondary outcomes

Transepidermal water loss
Time frame: immediately before the procedure to three months after last procedure
Description of overall manifestation by clinical photo and visiometer
Time frame: immediately before the procedure to three months after last procedure
Patients' subjective Treatment Satisfaction of the degree of skin aging improvement, wrinkles, pores, skin color, skin elasticity, skin dryness
Time frame: immediately before the procedure to three months after last procedure
Evaluation of researchers' skin improvement
Time frame: immediately before the procedure to three months after last procedure
Change of investigator's global assessment of lateral canthal line severity rating
Time frame: immediately before the procedure to three months after last procedure

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 29 Sep 2020.

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Active, not recruiting
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Active, not recruiting
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Enrolling by invitation
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 29 Sep 2020. 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 roughness (time frame: immediately before the procedure to three months after last procedure). The study lists 2 primary outcomes in all. 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 NCT03739398.

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 29 Sep 2020.