LaserNCT05811026
Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment
A study testing Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval) and Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval) in people with Laser and Periorbital, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laser, Periorbital
- What is being tested?
- Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval) and Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2023to 31 Dec 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single Center Clinical Study to Evaluate the Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment
The purpose of this research project is to investigate the treatment design, therapeutic effects and safety of the 1927 nm laser for the rejuvenation of the skin around the eyes.
Read the 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).
- Conditions
- Laser, Periorbital
- Being tested
- Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval), Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval)
- Keywords
- 1927 nm, periorbital rejuvenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval)Device
- 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
Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval)Device
- 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
| Study group | Role | What they receive |
|---|---|---|
| Arm A: 2-week interval between treatments | Experimental | 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. Receives: Device: Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval) |
| Arm B: 4-week interval between treatments | Experimental | 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. Receives: Device: Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Group A: baseline and week 8; Group B: baseline and week 12
Secondary outcomes (21)
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
Measured: Group A: baseline and week 8; Group B: baseline and week 12
Change From Baseline in Pigmentation Score at Visit 4 (End-of-study Session)
The pigmentation score is a parameter measured by the Antera 3D system, calculated based on the variation (arbitrary units) and average level (arbitrary units). Variation (arbitrary units) indicates mean value within the region of interest of all deviations from the pigmentation average level in absolute value. Average level (arbitrary units) indicates the average concentration of pigmentation in the region of interest. To interpret the pigmentation score, skin pigmentation is categorized into five intervals: Mild: 0-25, Moderate: 25-50, Advanced: 50-75, Severe: 75-100, Very Severe: >100. Higher scores indicate poorer pigmentation conditions. The overall pigmentation score ranges from 0 to infinity.
Change from baseline in pigmentation score at Visit 4 = pigmentation score at Visit 4 - pigmentation score at baseline
Measured: Group A: baseline and week 8; Group B: baseline and week 12
Change From Baseline in Pores' Index at Visit 4 (End-of-study Session)
The pores' index is an overall score representing skin porosity within the selected region of interest. It incorporates pore depth, size, and density-condensed into a single parameter. This index is particularly useful for the global evaluation of porosity reduction in before-and-after comparisons.
Formula: Index = (V / S) × 1000 V = total volume of pores in the selected area (mm³) S = selected area (mm²)
Change from baseline in pores' index at Visit 4 = pores' index at Visit 4-pores' indexe at baseline
Measured: Group A: baseline and week 8; Group B: baseline and week 12
Change From Baseline in Wrinkles' Score at Visit 4 (End-of-study Session)
The wrinkle score is a parameter measured by the Antera 3D system, calculated based on the indentation index (μm). The indentation index (μm) represents the average depth of all points or dents below the surface level. The indentation index (μm) values range from 0 to infinity.
To interpret the wrinkle score, skin damage is categorized into five intervals: Mild: 0-25, Moderate: 25-50, Advanced: 50-75, Severe: 75-100, Very Severe: >100. Higher scores indicate more severe wrinkle conditions. The overall wrinkle score ranges from 0 to infinity.
Change from baseline in wrinkles' score at Visit 4 = wrinkles' score at Visit 4 - wrinkles' score at baseline
Measured: Group A: baseline and week 8; Group B: baseline and week 12
Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session)
Global Aesthetic Improvement Score (GAIS) is a standardized 5-point scale used to assess overall aesthetic improvement following a cosmetic treatment. It ranges as follows: 5 - Very Much Improved, 4 - Much Improved, 3 - Improved, 2 - No Change, 1 - Worse Physician Assessment of GAIS refers to the GAIS score evaluated by the physician.
Change from Baseline in Physician Assessment of GAIS at Visit 4 is defined as the GAIS score assessed at Visit 4 in comparison to baseline.
Measured: Group A: baseline and week 8; Group B: baseline and week 12
Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session)
Global Aesthetic Improvement Score (GAIS) is a standardized 5-point scale used to assess overall aesthetic improvement following a cosmetic treatment. It ranges as follows: 5 - Very Much Improved, 4 - Much Improved, 3 - Improved, 2 - No Change, 1 - Worse Patient Assessment of GAIS refers to the GAIS score evaluated by the patient. Change from Baseline in Patient Assessment of GAIS at Visit 4 is defined as the GAIS score assessed at Visit 4 in comparison to baseline.
Measured: Group A: baseline and week 8; Group B: baseline and week 12
Change From Baseline in Texture Score at Visit 2
The texture score is a parameter measured by the Antera 3D system, calculated based on average roughness (Ra [μm]). Ra roughness, or average roughness, is a standard metric used to describe surface smoothness. It represents the average height of microscopic peaks and valleys on the skin surface. The Ra [μm] values range from 0 to infinity.
To interpret the texture score, skin surface roughness is categorized into five intervals: Mild: 0-25, Moderate: 25-50, Advanced: 50-75, Severe: 75-100, Very Severe: >100. Higher scores indicate poorer skin texture. The overall texture score ranges from 0 to infinity.
Change from baseline in texture score at Visit 2 = texture score at Visit 2 - texture score at baseline
Measured: Group A: baseline and week 2; Group B: baseline and week 4
Change From Baseline in Color Measurements (L*) at Visit 2
In the CIELAB color space, the L* value represents the lightness of a color, indicating how light or dark it appears. The scale ranges from 0 (black) to 100 (white), providing a standardized measure of brightness that aligns with human visual perception. This metric is particularly useful in assessing skin tone. The average L* value within a region of interest was calculated at each visit.
Change from baseline in L* at Visit 2 = L* at Visit 2 - L* at baseline
Measured: Group A: baseline and week 2; Group B: baseline and week 4
Change From Baseline in Pigmentation Score at Visit 2
The pigmentation score is a parameter measured by the Antera 3D system, calculated based on the variation (arbitrary units) and average level (arbitrary units). Variation (arbitrary units) indicates mean value within the region of interest of all deviations from the pigmentation average level in absolute value. Average level (arbitrary units) indicates the average concentration of pigmentation in the region of interest. To interpret the pigmentation score, skin pigmentation is categorized into five intervals: Mild: 0-25, Moderate: 25-50, Advanced: 50-75, Severe: 75-100, Very Severe: >100. Higher scores indicate poorer pigmentation conditions. The overall pigmentation score ranges from 0 to infinity.
Change from baseline in pigmentation score at Visit 2 = pigmentation score at Visit 2 - pigmentation score at baseline
Measured: Group A: baseline and week 2; Group B: baseline and week 4
Change From Baseline in Pores' Index at Visit 2
The pores' index is an overall score representing skin porosity within the selected region of interest. It incorporates pore depth, size, and density-condensed into a single parameter. This index is particularly useful for the global evaluation of porosity reduction in before-and-after comparisons.
Formula: Index = (V / S) × 1000 V = total volume of pores in the selected area (mm³) S = selected area (mm²)
Change from baseline in pores' index at Visit 2 = pores' index at Visit 2 - pores' index at baseline
Measured: Group A: baseline and week 2; Group B: baseline and week 4
Change From Baseline in Wrinkles' Score at Visit 2
The wrinkle score is a parameter measured by the Antera 3D system, calculated based on the indentation index (μm). The indentation index (μm) represents the average depth of all points or dents below the surface level. The indentation index (μm) values range from 0 to infinity.
To interpret the wrinkle score, skin damage is categorized into five intervals: Mild: 0-25, Moderate: 25-50, Advanced: 50-75, Severe: 75-100, Very Severe: >100. Higher scores indicate more severe wrinkle conditions. The overall wrinkle score ranges from 0 to infinity.
Change from baseline in wrinkles' score at Visit 2 = wrinkles' score at Visit 2 - wrinkles' score at baseline
Measured: Group A: baseline and week 2; Group B: baseline and week 4
Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2
Global Aesthetic Improvement Score (GAIS) is a standardized 5-point scale used to assess overall aesthetic improvement following a cosmetic treatment. It ranges as follows: 5 - Very Much Improved, 4 - Much Improved, 3 - Improved, 2 - No Change, 1 - Worse Physician Assessment of GAIS refers to the GAIS score evaluated by the physician.
Change from Baseline in Physician Assessment of GAIS at Visit 2 is defined as the GAIS score assessed at Visit 2 in comparison to baseline.
Measured: Group A: baseline and week 2; Group B: baseline and week 4
Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2
Global Aesthetic Improvement Score (GAIS) is a standardized 5-point scale used to assess overall aesthetic improvement following a cosmetic treatment. It ranges as follows: 5 - Very Much Improved, 4 - Much Improved, 3 - Improved, 2 - No Change, 1 - Worse Patient Assessment of GAIS refers to the GAIS score evaluated by the patient. Change from Baseline in Patient Assessment of GAIS at Visit 2 is defined as the GAIS score assessed at Visit 2 in comparison to baseline.
Measured: Group A: baseline and week 2; Group B: baseline and week 4
Change From Baseline in Texture Score at Visit 3
The texture score is a parameter measured by the Antera 3D system, calculated based on average roughness (Ra [μm]). Ra roughness, or average roughness, is a standard metric used to describe surface smoothness. It represents the average height of microscopic peaks and valleys on the skin surface. The Ra [μm] values range from 0 to infinity.
To interpret the texture score, skin surface roughness is categorized into five intervals: Mild: 0-25, Moderate: 25-50, Advanced: 50-75, Severe: 75-100, Very Severe: >100. Higher scores indicate poorer skin texture. The overall texture score ranges from 0 to infinity.
Change from baseline in texture score at Visit 3 = texture score at Visit 3 - texture score at baseline
Measured: Group A: baseline and week 4; Group B: baseline and week 8
Change From Baseline in Color Measurements (L*) at Visit 3
In the CIELAB color space, the L* value represents the lightness of a color, indicating how light or dark it appears. The scale ranges from 0 (black) to 100 (white), providing a standardized measure of brightness that aligns with human visual perception. This metric is particularly useful in assessing skin tone. The average L* value within a region of interest was calculated at each visit.
Change from baseline in L* at Visit 3 = L* at Visit 3 - L* at baseline
Measured: Group A: baseline and week 4; Group B: baseline and week 8
Change From Baseline in Pigmentation Score at Visit 3
The pigmentation score is a parameter measured by the Antera 3D system, calculated based on the variation (arbitrary units) and average level (arbitrary units). Variation (arbitrary units) indicates mean value within the region of interest of all deviations from the pigmentation average level in absolute value. Average level (arbitrary units) indicates the average concentration of pigmentation in the region of interest. To interpret the pigmentation score, skin pigmentation is categorized into five intervals: Mild: 0-25, Moderate: 25-50, Advanced: 50-75, Severe: 75-100, Very Severe: >100. Higher scores indicate poorer pigmentation conditions. The overall pigmentation score ranges from 0 to infinity.
Change from baseline in pigmentation score at Visit 3 = pigmentation score at Visit 3 - pigmentation score at baseline
Measured: Group A: baseline and week 4; Group B: baseline and week 8
Change From Baseline in Pores' Index at Visit 3
The pores' index is an overall score representing skin porosity within the selected region of interest. It incorporates pore depth, size, and density-condensed into a single parameter. This index is particularly useful for the global evaluation of porosity reduction in before-and-after comparisons.
Formula: Index = (V / S) × 1000 V = total volume of pores in the selected area (mm³) S = selected area (mm²)
Change from baseline in pores' index at Visit 3 = pores' index at Visit 3 - pores' index at baseline
Measured: Group A: baseline and week 4; Group B: baseline and week 8
Change From Baseline in Wrinkles' Score at Visit 3
The wrinkle score is a parameter measured by the Antera 3D system, calculated based on the indentation index (μm). The indentation index (μm) represents the average depth of all points or dents below the surface level. The indentation index (μm) values range from 0 to infinity.
To interpret the wrinkle score, skin damage is categorized into five intervals: Mild: 0-25, Moderate: 25-50, Advanced: 50-75, Severe: 75-100, Very Severe: >100. Higher scores indicate more severe wrinkle conditions. The overall wrinkle score ranges from 0 to infinity.
Change from baseline in wrinkles' score at Visit 3 = wrinkles' score at Visit 3 - wrinkles' score at baseline
Measured: Group A: baseline and week 4; Group B: baseline and week 8
Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3
Global Aesthetic Improvement Score (GAIS) is a standardized 5-point scale used to assess overall aesthetic improvement following a cosmetic treatment. It ranges as follows: 5 - Very Much Improved, 4 - Much Improved, 3 - Improved, 2 - No Change, 1 - Worse Physician Assessment of GAIS refers to the GAIS score evaluated by the physician.
Change from Baseline in Physician Assessment of GAIS at Visit 3 is defined as the GAIS score assessed at Visit 3 in comparison to baseline.
Measured: Group A: baseline and week 4; Group B: baseline and week 8
Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3
Global Aesthetic Improvement Score (GAIS) is a standardized 5-point scale used to assess overall aesthetic improvement following a cosmetic treatment. It ranges as follows: 5 - Very Much Improved, 4 - Much Improved, 3 - Improved, 2 - No Change, 1 - Worse Patient Assessment of GAIS refers to the GAIS score evaluated by the patient. Change from Baseline in Patient Assessment of GAIS at Visit 3 is defined as the GAIS score assessed at Visit 3 in comparison to baseline.
Measured: Group A: baseline and week 4; Group B: baseline and week 8
Visual Analogue Scale (VAS) During Treatment
The visual analogue scale (VAS) is a psychometric response scale that can be used in questionnaires, which a higher score suggests greater pain intensity. It ranges from 0 to 10 in increments of 1. A score of 0 cm indicates "no pain" and 10 indicates "worst pain imaginable".
Measured: Group A: week 0; Group B: week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start15 Mar 2023
- Primary completion21 Jun 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LaserStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BRIDGECON CO,.LTD.
- Responsible party
- Sponsor
- Investigators
- Yi-Hua Liao, MD/PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811026
- Sponsor's protocol ID
- 202207219DSC
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2023
- Last updated
- 18 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No