Clinical trial NCT05811026: Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment
Official title: An Open-Label, Single Center Clinical Study to Evaluate the Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laser
Periorbital
Keywords: 1927 nm
periorbital rejuvenation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: BRIDGECON CO,.LTD.
First posted: 2023-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Texture Score at Visit 4 (End-of-study Session)
timeFrame: Group A: baseline and week 8; Group B: baseline and week 12
Secondary outcomes:
measure: Change From Baseline in Color Measurements (L*) at Visit 4 (End-of-study Session)
timeFrame: Group A: baseline and week 8; Group B: baseline and week 12
measure: Change From Baseline in Pigmentation Score at Visit 4 (End-of-study Session)
timeFrame: Group A: baseline and week 8; Group B: baseline and week 12
measure: Change From Baseline in Pores' Index at Visit 4 (End-of-study Session)
timeFrame: Group A: baseline and week 8; Group B: baseline and week 12
measure: Change From Baseline in Wrinkles' Score at Visit 4 (End-of-study Session)
timeFrame: Group A: baseline and week 8; Group B: baseline and week 12
measure: Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session)
timeFrame: Group A: baseline and week 8; Group B: baseline and week 12
measure: Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 4 (End-of-study Session)
timeFrame: Group A: baseline and week 8; Group B: baseline and week 12
measure: Change From Baseline in Texture Score at Visit 2
timeFrame: Group A: baseline and week 2; Group B: baseline and week 4
measure: Change From Baseline in Color Measurements (L*) at Visit 2
timeFrame: Group A: baseline and week 2; Group B: baseline and week 4
measure: Change From Baseline in Pigmentation Score at Visit 2
timeFrame: Group A: baseline and week 2; Group B: baseline and week 4
measure: Change From Baseline in Pores' Index at Visit 2
timeFrame: Group A: baseline and week 2; Group B: baseline and week 4
measure: Change From Baseline in Wrinkles' Score at Visit 2
timeFrame: Group A: baseline and week 2; Group B: baseline and week 4
measure: Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2
timeFrame: Group A: baseline and week 2; Group B: baseline and week 4
measure: Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 2
timeFrame: Group A: baseline and week 2; Group B: baseline and week 4
measure: Change From Baseline in Texture Score at Visit 3
timeFrame: Group A: baseline and week 4; Group B: baseline and week 8
measure: Change From Baseline in Color Measurements (L*) at Visit 3
timeFrame: Group A: baseline and week 4; Group B: baseline and week 8
measure: Change From Baseline in Pigmentation Score at Visit 3
timeFrame: Group A: baseline and week 4; Group B: baseline and week 8
measure: Change From Baseline in Pores' Index at Visit 3
timeFrame: Group A: baseline and week 4; Group B: baseline and week 8
measure: Change From Baseline in Wrinkles' Score at Visit 3
timeFrame: Group A: baseline and week 4; Group B: baseline and week 8
measure: Change From Baseline in Physician Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3
timeFrame: Group A: baseline and week 4; Group B: baseline and week 8
measure: Change From Baseline in Patient Assessment of Global Aesthetic Improvement Score (GAIS), at Visit 3
timeFrame: Group A: baseline and week 4; Group B: baseline and week 8
measure: Visual Analogue Scale (VAS) During Treatment
timeFrame: Group A: week 0; Group B: week 0
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yi-Hua Liao, MD/PhD
role: STUDY_CHAIR
References: