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
Condition: Wrinkle
Study type: Interventional

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.
    

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.
    

Intervention name(s): LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR)); LASEMED laser(The Thulium laser with 1,927nm wavelength)
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Treatment