Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment

Study Overview
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Brief Summary
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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
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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).

Official Title
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An Open-Label, Single Center Clinical Study to Evaluate the Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment

Conditions
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Laser, Periorbital

Intervention / Treatment
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* Device: Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval)
* Device: Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: 2-week interval between treatments<br>The interval between the first, second, and third treatments in this arm is two weeks, and the follow-up session will take place four weeks after the third treatment. | Device: Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval)<br>* 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<br>|
| Experimental: Arm B: 4-week interval between treatments<br>The interval between the first, second, and third treatments in this arm is four weeks, and the follow-up session will take place four weeks after the third treatment. | Device: Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in texture score at visit 4 (follow-up session) | Texture score are parameters measured by Antera 3D (Ra, Rt, Rq). | Group A: baseline and week 8; Group B: baseline and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in color measurements (L*) at visit 4 (follow-up session) | Color measurement (L*) is a parameter measured by Antera 3D. L* represents perceptual lightness. | Group A: baseline and week 8; Group B: baseline and week 12 | 
| Change from baseline in pigmentation score at visit 4 (follow-up session) | Pigmentation score is a parameter measured by Antera 3D | Group A: baseline and week 8; Group B: baseline and week 12 | 
| Change from baseline in pores' index at visit 4 (follow-up session) | Pores' index is a parameter measured by Antera 3D. It represents the overall score of skin porosity in the selected region of interest. | 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 (follow-up session) | Global Aesthetic Improvement Score (GAIS) is done by the physician. It is a 5-point scale: 1-very much improved; 2-moderately improved; 3-somewhat improved; 4-no change; 5-worse. | 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 (follow-up session) | Global Aesthetic Improvement Score (GAIS) is done by the patient. It is a 5-point scale: 1-very much improved; 2-moderately improved; 3-somewhat improved; 4-no change; 5-worse. | Group A: baseline and week 8; Group B: baseline and week 12 | 
| Change from baseline in texture score at visit 2 | Texture score are parameters measured by Antera 3D (Ra, Rt, Rq). | Group A: baseline and week 2; Group B: baseline and week 4 | 
| Change from baseline in color measurements (L*) at visit 2 | Color measurement (L*) is a parameter measured by Antera 3D. L* represents perceptual | Group A: baseline and week 2; Group B: baseline and week 4 | 
| Change from baseline in pigmentation score at visit 2 | Pigmentation score is a parameter measured by Antera 3D. | Group A: baseline and week 2; Group B: baseline and week 4 | 
| Change from baseline in pores' index at visit 2 | Pores' index is a parameter measured by Antera 3D. It represents the overall score of skin porosity in the selected region of interest. | 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 done by the physician. It is a 5-point scale: 1-very much improved; 2-moderately improved; 3-somewhat improved; 4-no change; 5-worse. | 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 done by the patient. It is a 5-point scale: 1-very much improved; 2-moderately improved; 3-somewhat improved; 4-no change; 5-worse. | Group A: baseline and week 2; Group B: baseline and week 4 | 
| Change from baseline in texture score at visit 3 | Texture score are parameters measured by Antera 3D (Ra, Rt, Rq). | Group A: baseline and week 4; Group B: baseline and week 8 | 
| Change from baseline in color measurements (L*) at visit 3 | Color measurement (L*) is a parameter measured by Antera 3D. L* represents perceptual | Group A: baseline and week 4; Group B: baseline and week 8 | 
| Change from baseline in pigmentation score at visit 3 | Pigmentation score is a parameter measured by Antera 3D | Group A: baseline and week 4; Group B: baseline and week 8 | 
| Change from baseline in pores' index at visit 3 | Pores' index is a parameter measured by Antera 3D. It represents the overall score of skin porosity in the selected region of interest. | 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 done by the physician. It is a 5-point scale: 1-very much improved; 2-moderately improved; 3-somewhat improved; 4-no change; 5-worse. | 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 done by the patient. It is a 5-point scale: 1-very much improved; 2-moderately improved; 3-somewhat improved; 4-no change; 5-worse. It is evaluated by a questionnaire. | Group A: baseline and week 4; Group B: baseline and week 8 | 
| Adverse reaction after each treatment | The adverse reaction rate and severity of skin conditions, such as redness, swelling, burning, itching, pain, and peeling, were evaluated by questionaire for safety. It is a 4-point scale: 0-none; 1-mild; 2-moderate; 3-severe. | Group A: week 2, week 4 and week 8; Group B: week4, week 8 and week 12 | 
| 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. | Group A: week 0; Group B: week 0 | 
| Change from baseline in self-reported satisfaction with the skin around the eyes | Self-reported satisfaction evaluation is done by questionnaires. The questions include brightness of skin, fairness of skin, translucency of skin, smoothness of skin to the touch, softness of skin to the touch, hydration level of skin, radiance of skin, moisture retention of skin, evenness of skin tone, elasticity of skin, overall health of skin, plumpness of skin, number of brown spots on skin, color of brown spots on skin, size of brown spots on skin, overall area of brown spots on skin, fine lines on skin, youthfulness of skin appearance, refinement of skin texture, tightness of skin, feel like skin has been revitalized. It is a 5-point scale: 1-Very dissatisfied; 2-Dissatisfied; 3-Neutral; 4-Satisfied; 5-Very satisfied. | Group A: baseline, week 2, week 4 and week 8; Group B: baseline, week4, week 8 and week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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1927 nm, periorbital rejuvenation