An Open-Label, Single Center Clinical Study to Evaluate the Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Texture Score at Visit 4 (End-of-study Session)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval) (Device)
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.
Intervention: Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval) (Device)
Outcomes
Primary Outcomes
Change From Baseline in Texture Score at Visit 4 (End-of-study Session)
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Change From Baseline in Texture Score at Visit 2(Group A: baseline and week 2; Group B: baseline and week 4)
- Change From Baseline in Color Measurements (L*) at Visit 2(Group A: baseline and week 2; Group B: baseline and week 4)
- Change From Baseline in Pigmentation Score at Visit 2(Group A: baseline and week 2; Group B: baseline and week 4)
- Change From Baseline in Pores' Index at Visit 2(Group A: baseline and week 2; Group B: baseline and week 4)
- Change From Baseline in Wrinkles' Score at Visit 2(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(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(Group A: baseline and week 2; Group B: baseline and week 4)
- Change From Baseline in Texture Score at Visit 3(Group A: baseline and week 4; Group B: baseline and week 8)
- Change From Baseline in Color Measurements (L*) at Visit 3(Group A: baseline and week 4; Group B: baseline and week 8)
- Change From Baseline in Pigmentation Score at Visit 3(Group A: baseline and week 4; Group B: baseline and week 8)
- Change From Baseline in Pores' Index at Visit 3(Group A: baseline and week 4; Group B: baseline and week 8)
- Change From Baseline in Wrinkles' Score at Visit 3(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(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(Group A: baseline and week 4; Group B: baseline and week 8)
- Visual Analogue Scale (VAS) During Treatment(Group A: week 0; Group B: week 0)