Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment

NCT05811026 | Completed Results DMC FDA Device

• 1 other identifier: 202207219DSC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research project is to investigate the treatment design, therapeutic effects and safety of the 1927 nm laser for the rejuvenation of the skin around the eyes.

Conditions

Laser; Periorbital

Keywords

1927 nm; periorbital rejuvenation

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Texture Score at Visit 4 (End-of-study Session)

  The texture score is a parameter measured by the Antera 3D system, calculated based on average roughness (Ra \[μm\]). Ra roughness, or average roughness, is a standard metric used to describe surface smoothness. It represents the average height of microscopic peaks and valleys on the skin surface. The Ra \[μm\] values range from 0 to infinity. To interpret the texture score, skin surface roughness is categorized into five intervals: Mild: 0-25, Moderate: 25-50, Advanced: 50-75, Severe: 75-100, Very Severe: \>100. Higher scores indicate poorer skin texture. The overall texture score ranges from 0 to infinity. Change from baseline in texture score at Visit 4 = texture score at Visit 4 - texture score at baseline

  Group A: baseline and week 8; Group B: baseline and week 12

Secondary Outcomes (21)

• Change From Baseline in Color Measurements (L*) at Visit 4 (End-of-study Session)

  Group A: baseline and week 8; Group B: baseline and week 12

• Change From Baseline in Pigmentation Score at Visit 4 (End-of-study Session)

  Group A: baseline and week 8; Group B: baseline and week 12

• Change From Baseline in Pores' Index at Visit 4 (End-of-study Session)

  Group A: baseline and week 8; Group B: baseline and week 12

• Change From Baseline in Wrinkles' Score at Visit 4 (End-of-study Session)

  Group A: baseline and week 8; Group B: baseline and week 12

• Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session)

  Group A: baseline and week 8; Group B: baseline and week 12

Study Arms (2)

Arm A: 2-week interval between treatments

EXPERIMENTAL

The interval between the first, second, and third treatments in this arm is two weeks, and the follow-up session will take place four weeks after the third treatment.

Device: Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval)

Arm B: 4-week interval between treatments

EXPERIMENTAL

The interval between the first, second, and third treatments in this arm is four weeks, and the follow-up session will take place four weeks after the third treatment.

Device: Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval)

Interventions

Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval) DEVICE

* Visit 1 (W0): Clear + Brilliant™ Permea device periorbital treatment * Visit 2 (W2): Clear + Brilliant™ Permea device periorbital treatment * Visit 3 (W4): Clear + Brilliant™ Permea device periorbital treatment * Visit 4 (W8): Four weeks after the third treatment, a follow-up assessment will be performed

Arm A: 2-week interval between treatments

Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval) DEVICE

* Visit 1 (W0): Clear + Brilliant™ Permea device periorbital treatment * Visit 2 (W4): Clear + Brilliant™ Permea device periorbital treatment * Visit 3 (W8): Clear + Brilliant™ Permea device periorbital treatment * Visit 4 (W12): Four weeks after the third treatment, a follow-up assessment will be performed

Arm B: 4-week interval between treatments

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 30 and 65 years old;
• no significant skin lesions or inflammation on the facial skin;
• willing and able to comply with study requirements, instructions, and restrictions;
• signed informed consent form.

You may not qualify if:

• underwent facial active treatment, such as using laser, intense pulsed light, radiofrequency skin tightening, ultrasound skin tightening, botulinum toxin, or dermal fillers injection, within the previous six months;
• have chronic skin diseases such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo, rosacea, or keloid;
• pregnant or breastfeeding;
• suffered from acute illnesses or infections requiring treatment within 14 days before entering the study;
• have had serious illnesses (such as heart disease, lung disease, brain disease, or liver disease) within the previous three months;
• allergic to Lidocaine or Prilocaine used in topical anesthetic cream or suffer from methemoglobinemia;
• used any skin medication on the face within 30 days before the trial, deemed by the principal investigator to affect the study results;
• deemed unsuitable for the study by the principal investigator.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• BRIDGECON CO,.LTD.: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100229, Taiwan

Location

Results Point of Contact

• Title: Dr. Chang-Ming Huang
• Organization: Department of Dermatology, National Taiwan University Hospital, Taipei, Taiwan

daniel510791@gmail.com

+886-2-23123456

Study Officials

• Yi-Hua Liao, MD/PhD

  National Taiwan University Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 13, 2023
• Study Start: March 15, 2023
• Primary Completion: June 21, 2023
• Study Completion: December 31, 2024
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)