Trial Outcomes & Findings for Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment (NCT NCT05811026)

NCT ID: NCT05811026

Last Updated: 2025-06-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Group A: baseline and week 8; Group B: baseline and week 12
• Results posted on: 2025-06-18

Participant Flow

Participant milestones

Measure	Arm A: 2-week Interval Between Treatments 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment

Baseline characteristics by cohort

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed	Total n=20 Participants Total of all reporting groups
Age, Continuous	53 years n=5 Participants	45 years n=7 Participants	48 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Taiwan	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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 from 0 to infinity.

Change from baseline in texture score at Visit 4 = texture score at Visit 4 - texture score at baseline

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Texture Score at Visit 4 (End-of-study Session)	0.25 score on a scale Interval -0.375 to 7.125	-4.75 score on a scale Interval -7.25 to -0.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Color Measurements (L*) at Visit 4 (End-of-study Session)	-0.61495 score on a scale Interval -1.0353375 to -0.119875	-0.798575 score on a scale Interval -0.9895125 to -0.1737125

SECONDARY outcome

Timeframe: 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. Higher scores indicate poorer pigmentation conditions. The overall pigmentation score ranges from 0 to infinity.

Change from baseline in pigmentation score at Visit 4 = pigmentation score at Visit 4 - pigmentation score at baseline

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Pigmentation Score at Visit 4 (End-of-study Session)	-9 score on a scale Interval -9.5 to -7.0	-7.5 score on a scale Interval -10.375 to -4.75

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Pores' Index at Visit 4 (End-of-study Session)	-0.02675 score on a scale Interval -0.1378625 to 0.2650375	-0.63555 score on a scale Interval -0.8427125 to -0.1460625

SECONDARY outcome

Timeframe: 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 4 = wrinkles' score at Visit 4 - wrinkles' score at baseline

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Wrinkles' Score at Visit 4 (End-of-study Session)	13 score on a scale Interval -0.5 to 39.0	-29.75 score on a scale Interval -48.75 to -11.375

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session)	2.8 score on a scale Interval 2.4 to 3.0	3.0 score on a scale Interval 2.7 to 3.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session)	3.0 score on a scale Interval 2.0 to 3.0	2.0 score on a scale Interval 2.0 to 2.0

SECONDARY outcome

Timeframe: 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 from 0 to infinity.

Change from baseline in texture score at Visit 2 = texture score at Visit 2 - texture score at baseline

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Texture Score at Visit 2	1.5 score on a scale Interval -1.0 to 5.375	-4 score on a scale Interval -8.0 to -1.625

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Color Measurements (L*) at Visit 2	-0.4711 score on a scale Interval -0.6366375 to -0.0799375	-0.44215 score on a scale Interval -0.5409375 to 0.5504

SECONDARY outcome

Timeframe: 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. Higher scores indicate poorer pigmentation conditions. The overall pigmentation score ranges from 0 to infinity.

Change from baseline in pigmentation score at Visit 2 = pigmentation score at Visit 2 - pigmentation score at baseline

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Pigmentation Score at Visit 2	-0.5 score on a scale Interval -1.875 to 0.75	-2.25 score on a scale Interval -5.25 to 1.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Pores' Index at Visit 2	0.126725 score on a scale Interval -0.169925 to 0.777575	-0.4088 score on a scale Interval -0.6626875 to -0.3374875

SECONDARY outcome

Timeframe: 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 2 = wrinkles' score at Visit 2 - wrinkles' score at baseline

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Wrinkles' Score at Visit 2	11 score on a scale Interval 1.625 to 40.25	-23.5 score on a scale Interval -43.125 to -17.0

SECONDARY outcome

Timeframe: Group A: baseline and week 2; Group B: baseline and week 4

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 2 is defined as the GAIS score assessed at Visit 2 in comparison to baseline.

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2	4.0 score on a scale Interval 3.8 to 4.0	4.0 score on a scale Interval 3.7 to 4.0

SECONDARY outcome

Timeframe: Group A: baseline and week 2; Group B: baseline and week 4

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 2 is defined as the GAIS score assessed at Visit 2 in comparison to baseline.

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2	3.0 score on a scale Interval 3.0 to 4.0	3.0 score on a scale Interval 3.0 to 3.0

SECONDARY outcome

Timeframe: Group A: baseline and week 4; Group B: baseline and week 8

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 3 = texture score at Visit 3 - texture score at baseline

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Texture Score at Visit 3	2.75 score on a scale Interval -3.75 to 4.25	-4.5 score on a scale Interval -8.5 to -3.0

SECONDARY outcome

Timeframe: Group A: baseline and week 4; Group B: baseline and week 8

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 3 = L* at Visit 3 - L* at baseline

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=5 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Color Measurements (L*) at Visit 3	-1.1979 score on a scale Interval -1.744225 to -0.7522625	-0.26345 score on a scale Interval -0.64905 to 0.0077

SECONDARY outcome

Timeframe: Group A: baseline and week 4; Group B: baseline and week 8

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. Higher scores indicate poorer pigmentation conditions. The overall pigmentation score ranges from 0 to infinity.

Change from baseline in pigmentation score at Visit 3 = pigmentation score at Visit 3 - pigmentation score at baseline

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=5 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Pigmentation Score at Visit 3	-3 score on a scale Interval -5.875 to -0.75	-2.5 score on a scale Interval -5.0 to 0.0

SECONDARY outcome

Timeframe: Group A: baseline and week 4; Group B: baseline and week 8

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 3 = pores' index at Visit 3 - pores' index at baseline

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=5 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Pores' Index at Visit 3	0.299125 score on a scale Interval -0.123325 to 0.41035	-0.33025 score on a scale Interval -0.73005 to -0.1437

SECONDARY outcome

Timeframe: Group A: baseline and week 4; Group B: baseline and week 8

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 3 = wrinkles' score at Visit 3 - wrinkles' score at baseline

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=5 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Wrinkles' Score at Visit 3	20.25 score on a scale Interval -2.5 to 27.0	-21.5 score on a scale Interval -36.5 to -21.0

SECONDARY outcome

Timeframe: Group A: baseline and week 4; Group B: baseline and week 8

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 3 is defined as the GAIS score assessed at Visit 3 in comparison to baseline.

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3	3.5 score on a scale Interval 3.3 to 3.7	3.7 score on a scale Interval 3.3 to 3.9

SECONDARY outcome

Timeframe: Group A: baseline and week 4; Group B: baseline and week 8

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 3 is defined as the GAIS score assessed at Visit 3 in comparison to baseline.

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3	3.0 score on a scale Interval 3.0 to 3.0	2.0 score on a scale Interval 2.0 to 2.0

SECONDARY outcome

Timeframe: Group A: week 0; Group B: week 0

The visual analogue scale (VAS) is a psychometric response scale that can be used in questionnaires, which a higher score suggests greater pain intensity. It ranges from 0 to 10 in increments of 1. A score of 0 cm indicates "no pain" and 10 indicates "worst pain imaginable".

Outcome measures

Measure	Arm A: 2-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed	Arm B: 4-week Interval Between Treatments n=10 Participants 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. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed
Visual Analogue Scale (VAS) During Treatment	5 score on a scale Interval 4.0 to 7.0	6.5 score on a scale Interval 3.5 to 7.0

Adverse Events

Arm A: 2-week Interval Between Treatments

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm B: 4-week Interval Between Treatments

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm A: 2-week Interval Between Treatments n=10 participants at risk The interval between the first, second, and third treatments in this arm is two weeks, and the end-of-study session will take place four weeks after the third treatment. Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval): - 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, an end-of-study assessment will be performed There are a total 30 person-times of treatment.	Arm B: 4-week Interval Between Treatments n=10 participants at risk The interval between the first, second, and third treatments in this arm is four weeks, and the end-of-study session will take place four weeks after the third treatment. Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval): - 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, an end-of-study assessment will be performed There are a total 30 person-times of treatment.
Skin and subcutaneous tissue disorders Severe erythema	0.00% 0/10 • Arm A: 8 weeks, Arm B: 12 weeks	10.0% 1/10 • Number of events 1 • Arm A: 8 weeks, Arm B: 12 weeks
Skin and subcutaneous tissue disorders Severe swelling	10.0% 1/10 • Number of events 1 • Arm A: 8 weeks, Arm B: 12 weeks	20.0% 2/10 • Number of events 2 • Arm A: 8 weeks, Arm B: 12 weeks
Skin and subcutaneous tissue disorders Severe itchiness	0.00% 0/10 • Arm A: 8 weeks, Arm B: 12 weeks	10.0% 1/10 • Number of events 1 • Arm A: 8 weeks, Arm B: 12 weeks
Skin and subcutaneous tissue disorders Severe tenderness	0.00% 0/10 • Arm A: 8 weeks, Arm B: 12 weeks	20.0% 2/10 • Number of events 3 • Arm A: 8 weeks, Arm B: 12 weeks
Skin and subcutaneous tissue disorders Severe scaling	0.00% 0/10 • Arm A: 8 weeks, Arm B: 12 weeks	10.0% 1/10 • Number of events 1 • Arm A: 8 weeks, Arm B: 12 weeks

Additional Information

Dr. Chang-Ming Huang

Department of Dermatology, National Taiwan University Hospital, Taipei, Taiwan

Phone: +886-2-23123456

Email: daniel510791@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place