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

Yonsei University

Status: Completed

Conditions: Wrinkle

Treatments: Device: LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR)); Device: LASEMED laser(The Thulium laser with 1,927nm wavelength)

Study type: Interventional

Funder types: Other

Identifiers

NCT03739398

1-2018-0045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. If subjects do not want it or do not fill out a consent form
2. If subjects are allergic to local anesthetics (lidocaine)
3. Subjects who are Pregnant or lactating
4. 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
5. 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

LUTRONIC GENUS laser with LASEMD laser

Experimental group

Treatment:

Device: LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR))

LUTRONIC GENUS laser without LASEMD laser

Active Comparator group

Treatment:

Device: LASEMED laser(The Thulium laser with 1,927nm wavelength)