Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment

Not Applicable

Completed

Conditions: Periorbital
Laser

Registration Number: NCT05811026

Lead Sponsor: National Taiwan University Hospital

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

aged between 30 and 65 years old;
no significant skin lesions or inflammation on the facial skin;
willing and able to comply with study requirements, instructions, and restrictions;
signed informed consent form.

Exclusion Criteria

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;
have chronic skin diseases such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo, rosacea, or keloid;
pregnant or breastfeeding;
suffered from acute illnesses or infections requiring treatment within 14 days before entering the study;
have had serious illnesses (such as heart disease, lung disease, brain disease, or liver disease) within the previous three months;
allergic to Lidocaine or Prilocaine used in topical anesthetic cream or suffer from methemoglobinemia;
used any skin medication on the face within 30 days before the trial, deemed by the principal investigator to affect the study results;
deemed unsuitable for the study by the principal investigator.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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 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.
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
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".