An interventional study of Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval) and Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval) in Laser and Periorbital, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-18.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
The chromophore of the 1927 nm diode laser is mainly water, which can be used for skin rejuvenation. This study intends to use the Solta CLEAR+BRILLIANT Laser System, featuring a 1927 nm diode laser with 5 mJ energy, a treatment spot of 140 μm, a treatment depth of 170 μm, and a treatment coverage of approximately 5% per energy level after four rounds of treatment using the patented Intelligent Optical Tracking® System (IOTs). 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. This is an open-label, single-center clinical trial. Participants will be randomized into treatment groups, including Group A (treatment interval of 2 weeks) or Group B (treatment interval of 4 weeks).
National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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)
* 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
* 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
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
Time frame: Group A: baseline and week 8; Group B: baseline and week 12
Change From Baseline in Color Measurements (L*) at Visit 4 (End-of-study Session)
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
Time frame: 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)
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
Time frame: 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)
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
Time frame: 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)
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
Time frame: 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)
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.
Time frame: Group A: baseline and week 8; Group B: baseline and week 12
Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session)
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.
Time frame: Group A: baseline and week 8; Group B: baseline and week 12
Change From Baseline in Texture Score at Visit 2
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
Time frame: Group A: baseline and week 2; Group B: baseline and week 4
Change From Baseline in Color Measurements (L*) at Visit 2
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
Time frame: Group A: baseline and week 2; Group B: baseline and week 4
Change From Baseline in Pigmentation Score at Visit 2
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
Time frame: Group A: baseline and week 2; Group B: baseline and week 4
Change From Baseline in Pores' Index at Visit 2
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
Time frame: Group A: baseline and week 2; Group B: baseline and week 4
Change From Baseline in Wrinkles' Score at Visit 2
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
Time frame: Group A: baseline and week 2; Group B: baseline and week 4
Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2
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.
Time frame: Group A: baseline and week 2; Group B: baseline and week 4
Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2
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.
Time frame: Group A: baseline and week 2; Group B: baseline and week 4
Change From Baseline in Texture Score at Visit 3
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
Time frame: Group A: baseline and week 4; Group B: baseline and week 8
Change From Baseline in Color Measurements (L*) at Visit 3
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
Time frame: Group A: baseline and week 4; Group B: baseline and week 8
Change From Baseline in Pigmentation Score at Visit 3
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
Time frame: Group A: baseline and week 4; Group B: baseline and week 8
Change From Baseline in Pores' Index at Visit 3
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
Time frame: Group A: baseline and week 4; Group B: baseline and week 8
Change From Baseline in Wrinkles' Score at Visit 3
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
Time frame: Group A: baseline and week 4; Group B: baseline and week 8
Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3
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.
Time frame: Group A: baseline and week 4; Group B: baseline and week 8
Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3
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.
Time frame: Group A: baseline and week 4; Group B: baseline and week 8
Visual Analogue Scale (VAS) During Treatment
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".
Time frame: Group A: week 0; Group B: week 0
| Milestone | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Texture Score at Visit 4 (End-of-study Session) | 0.25 (-0.375 to 7.125) | -4.75 (-7.25 to -0.5) |
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
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Color Measurements (L*) at Visit 4 (End-of-study Session) | -0.61495 (-1.0353375 to -0.119875) | -0.798575 (-0.9895125 to -0.1737125) |
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
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Pigmentation Score at Visit 4 (End-of-study Session) | -9 (-9.5 to -7) | -7.5 (-10.375 to -4.75) |
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
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Pores' Index at Visit 4 (End-of-study Session) | -0.02675 (-0.1378625 to 0.2650375) | -0.63555 (-0.8427125 to -0.1460625) |
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
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Wrinkles' Score at Visit 4 (End-of-study Session) | 13 (-0.5 to 39) | -29.75 (-48.75 to -11.375) |
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.
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session) | 2.8 (2.4 to 3.0) | 3.0 (2.7 to 3.3) |
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.
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session) | 3.0 (2.0 to 3.0) | 2.0 (2.0 to 2.0) |
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
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Texture Score at Visit 2 | 1.5 (-1 to 5.375) | -4 (-8 to -1.625) |
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
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Color Measurements (L*) at Visit 2 | -0.4711 (-0.6366375 to -0.0799375) | -0.44215 (-0.5409375 to 0.5504) |
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
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Pigmentation Score at Visit 2 | -0.5 (-1.875 to 0.75) | -2.25 (-5.25 to 1.5) |
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
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Pores' Index at Visit 2 | 0.126725 (-0.169925 to 0.777575) | -0.4088 (-0.6626875 to -0.3374875) |
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
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Wrinkles' Score at Visit 2 | 11 (1.625 to 40.25) | -23.5 (-43.125 to -17) |
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.
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2 | 4.0 (3.8 to 4.0) | 4.0 (3.7 to 4.0) |
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.
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2 | 3.0 (3.0 to 4.0) | 3.0 (3.0 to 3.0) |
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
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Texture Score at Visit 3 | 2.75 (-3.75 to 4.25) | -4.5 (-8.5 to -3) |
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
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Color Measurements (L*) at Visit 3 | -1.1979 (-1.744225 to -0.7522625) | -0.26345 (-0.64905 to 0.0077) |
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
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Pigmentation Score at Visit 3 | -3 (-5.875 to -0.75) | -2.5 (-5 to 0) |
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
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Pores' Index at Visit 3 | 0.299125 (-0.123325 to 0.41035) | -0.33025 (-0.73005 to -0.1437) |
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
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Wrinkles' Score at Visit 3 | 20.25 (-2.5 to 27) | -21.5 (-36.5 to -21) |
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.
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3 | 3.5 (3.3 to 3.7) | 3.7 (3.3 to 3.9) |
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.
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3 | 3.0 (3.0 to 3.0) | 2.0 (2.0 to 2.0) |
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".
| score on a scale | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Visual Analogue Scale (VAS) During Treatment | 5 (4 to 7) | 6.5 (3.5 to 7) |
Collected over Arm A: 8 weeks, Arm B: 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: 2-week Interval Between Treatments | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Arm B: 4-week Interval Between Treatments | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Event | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments |
|---|---|---|
| Severe swellingSkin and subcutaneous tissue disorders | 1/10 | 2/10 |
| Severe tendernessSkin and subcutaneous tissue disorders | 0/10 | 2/10 |
| Severe erythemaSkin and subcutaneous tissue disorders | 0/10 | 1/10 |
| Severe itchinessSkin and subcutaneous tissue disorders | 0/10 | 1/10 |
| Severe scalingSkin and subcutaneous tissue disorders | 0/10 | 1/10 |
| Age, Continuous(years) | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments | Total |
|---|---|---|---|
| Median | 53 (48 to 56.75) | 45 (44.25 to 47.5) | 48 (45 to 54.5) |
| Sex: Female, Male(Participants) | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments | Total |
|---|---|---|---|
| Female | 9 | 9 | 18 |
| Male | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 10 | 10 | 20 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Arm A: 2-week Interval Between Treatments | Arm B: 4-week Interval Between Treatments | Total |
|---|---|---|---|
| Taiwan | 10 | 10 | 20 |
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National Taiwan University Hospital