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

NCT ID: NCT03739398

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-24
• Study Completion Date: 2019-04-23

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.

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.

Conditions

Wrinkle

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LUTRONIC GENUS laser with LASEMD laser

Group Type: EXPERIMENTAL

LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR))

Intervention Type: 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 without LASEMD laser

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1-2018-0045

Identifier Type: -

Identifier Source: org_study_id