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

NCT03739398 | Completed

• 1 other identifier: 1-2018-0045
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Transepidermal water loss

  immediately before the procedure to three months after last procedure

• Description of overall manifestation by clinical photo and visiometer

  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

  immediately before the procedure to three months after last procedure

• Evaluation of researchers' skin improvement

  immediately before the procedure to three months after last procedure

• Change of investigator's global assessment of lateral canthal line severity rating

  immediately before the procedure to three months after last procedure

Study Arms (2)

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)

Interventions

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.

LUTRONIC GENUS laser with LASEMD laser

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.

LUTRONIC GENUS laser without LASEMD laser

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 13, 2018
• Study Start: August 24, 2018
• Primary Completion: April 23, 2019
• Study Completion: April 23, 2019
• Last Updated: September 29, 2020

Record last verified: 2020-09

Locations

KR (1)