Laser, Periorbital
Conditions
Keywords
1927 nm, periorbital rejuvenation
Brief summary
The purpose of this research project is to investigate the treatment design, therapeutic effects and safety of the 1927 nm laser for the rejuvenation of the skin around the eyes.
Detailed description
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).
Interventions
DEVICEPeriorbital 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, a follow-up assessment will be performed
DEVICEPeriorbital 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, a follow-up assessment will be performed
Sponsors
BRIDGECON CO,.LTD.
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. aged between 30 and 65 years old; 2. no significant skin lesions or inflammation on the facial skin; 3. willing and able to comply with study requirements, instructions, and restrictions; 4. signed informed consent form.
Exclusion criteria
1. underwent facial active treatment, such as using laser, intense pulsed light, radiofrequency skin tightening, ultrasound skin tightening, botulinum toxin, or dermal fillers injection, within the previous six months; 2. have chronic skin diseases such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo, rosacea, or keloid; 3. pregnant or breastfeeding; 4. suffered from acute illnesses or infections requiring treatment within 14 days before entering the study; 5. have had serious illnesses (such as heart disease, lung disease, brain disease, or liver disease) within the previous three months; 6. allergic to Lidocaine or Prilocaine used in topical anesthetic cream or suffer from methemoglobinemia; 7. used any skin medication on the face within 30 days before the trial, deemed by the principal investigator to affect the study results; 8. deemed unsuitable for the study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Texture Score at Visit 4 (End-of-study Session) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pigmentation Score at Visit 4 (End-of-study Session) | Group A: baseline and week 8; Group B: baseline and week 12 | 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 |
| Change From Baseline in Pores' Index at Visit 4 (End-of-study Session) | Group A: baseline and week 8; Group B: baseline and week 12 | 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 |
| Change From Baseline in Wrinkles' Score at Visit 4 (End-of-study Session) | Group A: baseline and week 8; Group B: baseline and week 12 | 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 |
| Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session) | Group A: baseline and week 8; Group B: baseline and week 12 | 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. |
| Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session) | Group A: baseline and week 8; Group B: baseline and week 12 | 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. |
| Change From Baseline in Texture Score at Visit 2 | 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 |
| Change From Baseline in Color Measurements (L*) at Visit 2 | 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 |
| Change From Baseline in Pigmentation Score at Visit 2 | 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 |
| Change From Baseline in Pores' Index at Visit 2 | 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 |
| Change From Baseline in Wrinkles' Score at Visit 2 | 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 |
| Change From Baseline in Color Measurements (L*) at Visit 4 (End-of-study Session) | Group A: baseline and week 8; Group B: baseline and week 12 | 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 |
| Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2 | 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. |
| Change From Baseline in Texture Score at Visit 3 | 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 |
| Change From Baseline in Color Measurements (L*) at Visit 3 | 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 |
| Change From Baseline in Pigmentation Score at Visit 3 | 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 |
| Change From Baseline in Pores' Index at Visit 3 | 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 |
| Change From Baseline in Wrinkles' Score at Visit 3 | 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 |
| Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3 | 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. |
| Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3 | 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. |
| Visual Analogue Scale (VAS) During Treatment | 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. |
| Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2 | 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Arm A: 2-week Interval Between Treatments | Total | Arm B: 4-week Interval Between Treatments |
|---|---|---|---|
| Age, Continuous | 53 years | 48 years | 45 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 20 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Female | 9 Participants | 18 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 1 / 10 | 3 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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
Time frame: Group A: baseline and week 8; Group B: baseline and week 12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Texture Score at Visit 4 (End-of-study Session) | 0.25 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Texture Score at Visit 4 (End-of-study Session) | -4.75 score on a scale |
p-value: 0.075Wilcoxon (Mann-Whitney)
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
Time frame: Group A: baseline and week 2; Group B: baseline and week 4
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Color Measurements (L*) at Visit 2 | -0.4711 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Color Measurements (L*) at Visit 2 | -0.44215 score on a scale |
p-value: 0.4274Wilcoxon (Mann-Whitney)
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
Time frame: Group A: baseline and week 4; Group B: baseline and week 8
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Color Measurements (L*) at Visit 3 | -1.1979 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Color Measurements (L*) at Visit 3 | -0.26345 score on a scale |
p-value: 0.0982Wilcoxon (Mann-Whitney)
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
Time frame: Group A: baseline and week 8; Group B: baseline and week 12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Color Measurements (L*) at Visit 4 (End-of-study Session) | -0.61495 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Color Measurements (L*) at Visit 4 (End-of-study Session) | -0.798575 score on a scale |
p-value: 0.4727Wilcoxon (Mann-Whitney)
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.
Time frame: Group A: baseline and week 2; Group B: baseline and week 4
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2 | 3.0 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2 | 3.0 score on a scale |
p-value: 0.3327Wilcoxon (Mann-Whitney)
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.
Time frame: Group A: baseline and week 4; Group B: baseline and week 8
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3 | 3.0 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3 | 2.0 score on a scale |
p-value: 0.0067Wilcoxon (Mann-Whitney)
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.
Time frame: Group A: baseline and week 8; Group B: baseline and week 12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-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 score on a scale |
| 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) | 2.0 score on a scale |
p-value: 0.1009Wilcoxon (Mann-Whitney)
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.
Time frame: Group A: baseline and week 2; Group B: baseline and week 4
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2 | 4.0 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2 | 4.0 score on a scale |
p-value: 0.6231Wilcoxon (Mann-Whitney)
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.
Time frame: Group A: baseline and week 4; Group B: baseline and week 8
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3 | 3.5 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3 | 3.7 score on a scale |
p-value: 0.6961Wilcoxon (Mann-Whitney)
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.
Time frame: Group A: baseline and week 8; Group B: baseline and week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm A: 2-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 score on a scale |
| 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) | 3.0 score on a scale |
p-value: 0.3123Wilcoxon (Mann-Whitney)
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
Time frame: Group A: baseline and week 2; Group B: baseline and week 4
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Pigmentation Score at Visit 2 | -0.5 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Pigmentation Score at Visit 2 | -2.25 score on a scale |
p-value: 0.6497Wilcoxon (Mann-Whitney)
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
Time frame: Group A: baseline and week 4; Group B: baseline and week 8
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Pigmentation Score at Visit 3 | -3 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Pigmentation Score at Visit 3 | -2.5 score on a scale |
p-value: 0.8541Wilcoxon (Mann-Whitney)
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
Time frame: Group A: baseline and week 8; Group B: baseline and week 12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Pigmentation Score at Visit 4 (End-of-study Session) | -9 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Pigmentation Score at Visit 4 (End-of-study Session) | -7.5 score on a scale |
p-value: 0.7326Wilcoxon (Mann-Whitney)
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
Time frame: Group A: baseline and week 2; Group B: baseline and week 4
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Pores' Index at Visit 2 | 0.126725 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Pores' Index at Visit 2 | -0.4088 score on a scale |
p-value: 0.0006Wilcoxon (Mann-Whitney)
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
Time frame: Group A: baseline and week 4; Group B: baseline and week 8
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Pores' Index at Visit 3 | 0.299125 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Pores' Index at Visit 3 | -0.33025 score on a scale |
p-value: 0.0758Wilcoxon (Mann-Whitney)
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
Time frame: Group A: baseline and week 8; Group B: baseline and week 12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Pores' Index at Visit 4 (End-of-study Session) | -0.02675 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Pores' Index at Visit 4 (End-of-study Session) | -0.63555 score on a scale |
p-value: 0.0757Wilcoxon (Mann-Whitney)
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
Time frame: Group A: baseline and week 2; Group B: baseline and week 4
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Texture Score at Visit 2 | 1.5 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Texture Score at Visit 2 | -4 score on a scale |
p-value: 0.0088Wilcoxon (Mann-Whitney)
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
Time frame: Group A: baseline and week 4; Group B: baseline and week 8
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Texture Score at Visit 3 | 2.75 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Texture Score at Visit 3 | -4.5 score on a scale |
p-value: 0.0752Wilcoxon (Mann-Whitney)
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
Time frame: Group A: baseline and week 2; Group B: baseline and week 4
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Wrinkles' Score at Visit 2 | 11 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Wrinkles' Score at Visit 2 | -23.5 score on a scale |
p-value: 0.0002Wilcoxon (Mann-Whitney)
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
Time frame: Group A: baseline and week 4; Group B: baseline and week 8
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Wrinkles' Score at Visit 3 | 20.25 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Wrinkles' Score at Visit 3 | -21.5 score on a scale |
p-value: 0.066Wilcoxon (Mann-Whitney)
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
Time frame: Group A: baseline and week 8; Group B: baseline and week 12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Change From Baseline in Wrinkles' Score at Visit 4 (End-of-study Session) | 13 score on a scale |
| Arm B: 4-week Interval Between Treatments | Change From Baseline in Wrinkles' Score at Visit 4 (End-of-study Session) | -29.75 score on a scale |
p-value: 0.0376Wilcoxon (Mann-Whitney)
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.
Time frame: Group A: week 0; Group B: week 0
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A: 2-week Interval Between Treatments | Visual Analogue Scale (VAS) During Treatment | 5 score on a scale |
| Arm B: 4-week Interval Between Treatments | Visual Analogue Scale (VAS) During Treatment | 6.5 score on a scale |