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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LUTRONIC GENUS laser with LASEMD laser | Experimental |
| |
| LUTRONIC GENUS laser without LASEMD laser | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin roughness | The roughness and wrinkle of the skin corresponding to the wrinkles of the outer eyelid | immediately before the procedure to three months after last procedure |
| wrinkle | the wrinkle of glabella were measured using an Antera 3D camera and compared | immediately before the procedure to three months after last procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Transepidermal water loss | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine | Seoul | 03722 | South Korea |
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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.
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| LASEMED laser(The Thulium laser with 1,927nm wavelength) | Device | 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. |
|
| 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) | 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) | 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) | immediately before the procedure to three months after last procedure |