Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment

NCT ID: NCT05811026

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2024-12-31

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).

Conditions

Laser; Periorbital

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval)

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval)

Intervention Type: 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

Interventions

Periorbital rejuvenation with a 1927 nm diode laser treatment (2-week interval)

• 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

Intervention Type: DEVICE

Periorbital rejuvenation with a 1927 nm diode laser treatment (4-week interval)

• 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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BRIDGECON CO,.LTD.

UNKNOWN

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi-Hua Liao, MD/PhD

Role: STUDY_CHAIR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

202207219DSC

Identifier Type: -

Identifier Source: org_study_id