NCT05811026

Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment

Completed NA Results posted Last updated 18 June 2025

What this trial tests

NA trial testing Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval) in Laser in 20 participants. Completed in 31 December 2024.

Timeline

15 March 2023

Primary endpoint
21 June 2023

31 December 2024

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	15 March 2023
Primary completion	21 June 2023
Estimated completion	31 December 2024
Sites	1 location across Taiwan

Drugs / interventions tested

• Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval)
• Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval)

Conditions studied

• Laser — all drugs for Laser →
• Periorbital — all drugs for Periorbital →

Sponsor

National Taiwan University Hospital

Who can join

Adults 30 to 65, any sex, with Laser or Periorbital. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Texture Score at Visit 4 (End-of-study Session) Primary · Group A: baseline and week 8; Group B: baseline and week 12

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 fro

Group	Value	95% CI
Arm A: 2-week Interval Between Treatments	0.25	-0.375 – 7.125
Arm B: 4-week Interval Between Treatments	-4.75	-7.25 – -0.5

Change From Baseline in Color Measurements (L*) at Visit 4 (End-of-study Session) Secondary · Group A: baseline and week 8; Group B: baseline and week 12

In the CIELAB color space, the L\* value represents the lightness of a color, indicating how light or dark it appears. The scale ranges from 0 (black) to 100 (white), providing a standardized measure of brightness that aligns with human visual perception. This metric is particularly useful in assessing skin tone. The average L\* value within a region of interest was calculated at each visit. Change from baseline in L\* at Visit 4 = L\* at Visit 4 - L\* at baseline

Group	Value	95% CI
Arm A: 2-week Interval Between Treatments	-0.61495	-1.0353375 – -0.119875
Arm B: 4-week Interval Between Treatments	-0.798575	-0.9895125 – -0.1737125

Change From Baseline in Pigmentation Score at Visit 4 (End-of-study Session) Secondary · Group A: baseline and week 8; Group B: baseline and week 12

The pigmentation score is a parameter measured by the Antera 3D system, calculated based on the variation (arbitrary units) and average level (arbitrary units). Variation (arbitrary units) indicates mean value within the region of interest of all deviations from the pigmentation average level in absolute value. Average level (arbitrary units) indicates the average concentration of pigmentation in the region of interest. To interpret the pigmentation score, skin pigmentation is categorized into five intervals: Mild: 0-25, Moderate: 25-50, Advanced: 50-75, Severe: 75-100, Very Severe: \>100. Hig

Group	Value	95% CI
Arm A: 2-week Interval Between Treatments	-9	-9.5 – -7
Arm B: 4-week Interval Between Treatments	-7.5	-10.375 – -4.75

Change From Baseline in Pores' Index at Visit 4 (End-of-study Session) Secondary · Group A: baseline and week 8; Group B: baseline and week 12

The pores' index is an overall score representing skin porosity within the selected region of interest. It incorporates pore depth, size, and density-condensed into a single parameter. This index is particularly useful for the global evaluation of porosity reduction in before-and-after comparisons. Formula: Index = (V / S) × 1000 V = total volume of pores in the selected area (mm³) S = selected area (mm²) Change from baseline in pores' index at Visit 4 = pores' index at Visit 4-pores' indexe at baseline

Group	Value	95% CI
Arm A: 2-week Interval Between Treatments	-0.02675	-0.1378625 – 0.2650375
Arm B: 4-week Interval Between Treatments	-0.63555	-0.8427125 – -0.1460625

Change From Baseline in Wrinkles' Score at Visit 4 (End-of-study Session) Secondary · Group A: baseline and week 8; Group B: baseline and week 12

The wrinkle score is a parameter measured by the Antera 3D system, calculated based on the indentation index (μm). The indentation index (μm) represents the average depth of all points or dents below the surface level. The indentation index (μm) values range from 0 to infinity. To interpret the wrinkle score, skin damage is categorized into five intervals: Mild: 0-25, Moderate: 25-50, Advanced: 50-75, Severe: 75-100, Very Severe: \>100. Higher scores indicate more severe wrinkle conditions. The overall wrinkle score ranges from 0 to infinity. Change from baseline in wrinkles' score at Visit

Group	Value	95% CI
Arm A: 2-week Interval Between Treatments	13	-0.5 – 39
Arm B: 4-week Interval Between Treatments	-29.75	-48.75 – -11.375

Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session) Secondary · Group A: baseline and week 8; Group B: baseline and week 12

Global Aesthetic Improvement Score (GAIS) is a standardized 5-point scale used to assess overall aesthetic improvement following a cosmetic treatment. It ranges as follows: 5 - Very Much Improved, 4 - Much Improved, 3 - Improved, 2 - No Change, 1 - Worse Physician Assessment of GAIS refers to the GAIS score evaluated by the physician. Change from Baseline in Physician Assessment of GAIS at Visit 4 is defined as the GAIS score assessed at Visit 4 in comparison to baseline.

Group	Value	95% CI
Arm A: 2-week Interval Between Treatments	2.8	2.4 – 3.0
Arm B: 4-week Interval Between Treatments	3.0	2.7 – 3.3

Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session) Secondary · Group A: baseline and week 8; Group B: baseline and week 12

Global Aesthetic Improvement Score (GAIS) is a standardized 5-point scale used to assess overall aesthetic improvement following a cosmetic treatment. It ranges as follows: 5 - Very Much Improved, 4 - Much Improved, 3 - Improved, 2 - No Change, 1 - Worse Patient Assessment of GAIS refers to the GAIS score evaluated by the patient. Change from Baseline in Patient Assessment of GAIS at Visit 4 is defined as the GAIS score assessed at Visit 4 in comparison to baseline.

Group	Value	95% CI
Arm A: 2-week Interval Between Treatments	3.0	2.0 – 3.0
Arm B: 4-week Interval Between Treatments	2.0	2.0 – 2.0

Change From Baseline in Texture Score at Visit 2 Secondary · Group A: baseline and week 2; Group B: baseline and week 4

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 fro

Group	Value	95% CI
Arm A: 2-week Interval Between Treatments	1.5	-1 – 5.375
Arm B: 4-week Interval Between Treatments	-4	-8 – -1.625

Change From Baseline in Color Measurements (L*) at Visit 2 Secondary · Group A: baseline and week 2; Group B: baseline and week 4

In the CIELAB color space, the L\* value represents the lightness of a color, indicating how light or dark it appears. The scale ranges from 0 (black) to 100 (white), providing a standardized measure of brightness that aligns with human visual perception. This metric is particularly useful in assessing skin tone. The average L\* value within a region of interest was calculated at each visit. Change from baseline in L\* at Visit 2 = L\* at Visit 2 - L\* at baseline

Group	Value	95% CI
Arm A: 2-week Interval Between Treatments	-0.4711	-0.6366375 – -0.0799375
Arm B: 4-week Interval Between Treatments	-0.44215	-0.5409375 – 0.5504

Change From Baseline in Pigmentation Score at Visit 2 Secondary · Group A: baseline and week 2; Group B: baseline and week 4

The pigmentation score is a parameter measured by the Antera 3D system, calculated based on the variation (arbitrary units) and average level (arbitrary units). Variation (arbitrary units) indicates mean value within the region of interest of all deviations from the pigmentation average level in absolute value. Average level (arbitrary units) indicates the average concentration of pigmentation in the region of interest. To interpret the pigmentation score, skin pigmentation is categorized into five intervals: Mild: 0-25, Moderate: 25-50, Advanced: 50-75, Severe: 75-100, Very Severe: \>100. Hig

Group	Value	95% CI
Arm A: 2-week Interval Between Treatments	-0.5	-1.875 – 0.75
Arm B: 4-week Interval Between Treatments	-2.25	-5.25 – 1.5

Change From Baseline in Pores' Index at Visit 2 Secondary · Group A: baseline and week 2; Group B: baseline and week 4

The pores' index is an overall score representing skin porosity within the selected region of interest. It incorporates pore depth, size, and density-condensed into a single parameter. This index is particularly useful for the global evaluation of porosity reduction in before-and-after comparisons. Formula: Index = (V / S) × 1000 V = total volume of pores in the selected area (mm³) S = selected area (mm²) Change from baseline in pores' index at Visit 2 = pores' index at Visit 2 - pores' index at baseline

Group	Value	95% CI
Arm A: 2-week Interval Between Treatments	0.126725	-0.169925 – 0.777575
Arm B: 4-week Interval Between Treatments	-0.4088	-0.6626875 – -0.3374875

Change From Baseline in Wrinkles' Score at Visit 2 Secondary · Group A: baseline and week 2; Group B: baseline and week 4

The wrinkle score is a parameter measured by the Antera 3D system, calculated based on the indentation index (μm). The indentation index (μm) represents the average depth of all points or dents below the surface level. The indentation index (μm) values range from 0 to infinity. To interpret the wrinkle score, skin damage is categorized into five intervals: Mild: 0-25, Moderate: 25-50, Advanced: 50-75, Severe: 75-100, Very Severe: \>100. Higher scores indicate more severe wrinkle conditions. The overall wrinkle score ranges from 0 to infinity. Change from baseline in wrinkles' score at Visit

Group	Value	95% CI
Arm A: 2-week Interval Between Treatments	11	1.625 – 40.25
Arm B: 4-week Interval Between Treatments	-23.5	-43.125 – -17

Adverse events — posted to ClinicalTrials.gov

Time frame: Arm A: 8 weeks, Arm B: 12 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A: 2-week Interval Between Treatments

Serious: 0/10 (0%)

Deaths: 0/10

Arm B: 4-week Interval Between Treatments

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (5 terms — click to expand)

Reaction	System	Arm A: 2-week Interval Bet…	Arm B: 4-week Interval Bet…
Severe swelling	Skin and subcutaneous tissue disorders	—	—
Severe tenderness	Skin and subcutaneous tissue disorders	—	—
Severe erythema	Skin and subcutaneous tissue disorders	—	—
Severe itchiness	Skin and subcutaneous tissue disorders	—	—
Severe scaling	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT05811026 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Nonablative Fractional 1927-nm Laser for Periorbital Rejuvenation: A Prospective, Double-Arm, Open-Label Trial.
   Huang CM, Sheen YS, Liao YH. · · 2025 · PMID 40536161 · DOI 10.1111/jocd.70274