Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03739398
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Wrinkle Device: LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR)) Device: LASEMED laser(The Thulium laser with 1,927nm wavelength) Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
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
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
Actual Study Start Date : August 24, 2018
Estimated Primary Completion Date : May 23, 2019
Estimated Study Completion Date : May 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Aging
Drug Information available for: Thulium

Arm Intervention/treatment
Experimental: LUTRONIC GENUS laser with LASEMD laser Device: 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.

Active Comparator: LUTRONIC GENUS laser without LASEMD laser Device: 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.





Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Transepidermal water loss [ Time Frame: immediately before the procedure to three months after last procedure ]
  2. Description of overall manifestation by clinical photo and visiometer [ Time Frame: immediately before the procedure to three months after last procedure ]
    pigmentation, erythema, scaliness will be checked by photo and visiometer

  3. 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 ]
    (0 : Not satisfied, 1 : Somewhat satisfied, 2 : Satisfied, 3: Very satisfied)

  4. Evaluation of researchers' skin improvement [ Time Frame: immediately before the procedure to three months after last procedure ]
    (0 : Not improved, 1 : 1 ~ 25% improvement, 2 : 26 ~ 50% improvement, 3: 51 ~ 75% improvement, 4: More than 76% improvement)

  5. Change of investigator's global assessment of lateral canthal line severity rating [ Time Frame: immediately before the procedure to three months after last procedure ]
    ( 0: Absent, 1: minimal, 2 : mild, 3: moderate, 4: severe)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739398


Contacts
Layout table for location contacts
Contact: Sang Ho Oh, MD,PhD. +82 2 2228 2080 oddung93@yuhs.ac

Locations
Layout table for location information
Korea, Republic of
Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Sang Ho Oh, MD, PhD.    +82 2 2228 2080    oddung93@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03739398     History of Changes
Other Study ID Numbers: 1-2018-0045
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No