| Primary | 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 | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 8; Group B: baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, an end-of-study assessment will be performed
|
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.25(-0.375 to 7.125)
- OG001-4.75(-7.25 to -0.5)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Wilcoxon (Mann-Whitney) | | 0.075 | Statistical significance was defined as a p-value < 0.05. | Median Difference (Net) | 5 | | | 2-Sided | | | | | | Differece = (2-week interval group) - (4-week interval group) | | Superiority | | |
|
| Secondary | 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 | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 8; Group B: baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, a follow-up assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, a follow-up assessment will be performed
|
|
| Secondary | 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 | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 8; Group B: baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 |
|
| Secondary | 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 | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 8; Group B: baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, an end-of-study assessment will be performed
|
|
| Secondary | 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 | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 8; Group B: baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | Arm B: 4-week Interval Between Treatments | |
|
| Secondary | 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. | | Posted | | Mean | Inter-Quartile Range | score on a scale | | Group A: baseline and week 8; Group B: baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, an end-of-study assessment will be performed
|
|
| Secondary | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 8; Group B: baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, an end-of-study assessment will be performed
|
|
| Secondary | 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 | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 2; Group B: baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | Arm B: 4-week Interval Between Treatments | |
|
| Secondary | 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 | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 2; Group B: baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, an end-of-study assessment will be performed
|
|
| Secondary | 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 | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 2; Group B: baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 |
|
| Secondary | 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 | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 2; Group B: baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, an end-of-study assessment will be performed
|
|
| Secondary | 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 | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 2; Group B: baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, an end-of-study assessment will be performed
|
|
| Secondary | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 2; Group B: baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, an end-of-study assessment will be performed
|
|
| Secondary | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 2; Group B: baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, an end-of-study assessment will be performed
|
|
| Secondary | 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 | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 4; Group B: baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | Arm B: 4-week Interval Between Treatments | |
|
| Secondary | 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 | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 4; Group B: baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, an end-of-study assessment will be performed
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| Secondary | 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 | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 4; Group B: baseline and week 8 | | | | ID | Title | Description |
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| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 |
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| Secondary | 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 | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 4; Group B: baseline and week 8 | | | | ID | Title | Description |
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| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, an end-of-study assessment will be performed
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| Secondary | 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 | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 4; Group B: baseline and week 8 | | | | ID | Title | Description |
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| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, an end-of-study assessment will be performed
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| Secondary | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 4; Group B: baseline and week 8 | | | | ID | Title | Description |
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| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, an end-of-study assessment will be performed
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| Secondary | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: baseline and week 4; Group B: baseline and week 8 | | | | ID | Title | Description |
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| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, an end-of-study assessment will be performed
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| Secondary | 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". | | Posted | | Median | Inter-Quartile Range | score on a scale | | Group A: week 0; Group B: week 0 | | | | ID | Title | Description |
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| OG000 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W2): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W8): Four weeks after the third treatment, an end-of-study assessment will be performed
| | OG001 | 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 + Brilliantâ„¢ Permea device periorbital treatment
- Visit 2 (W4): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 3 (W8): Clear + Brilliantâ„¢ Permea device periorbital treatment
- Visit 4 (W12): Four weeks after the third treatment, an end-of-study assessment will be performed
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