- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05811026
Efficacy of Periorbital Rejuvenation With a 1927 nm Diode Laser Treatment
March 30, 2023 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chang-Ming Huang, MD
- Phone Number: +886-987793689
- Email: daniel510791@gmail.com
Study Locations
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Taipei, Taiwan, 100229
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Chang-Ming Huang, M.D.
- Phone Number: +886-972652516
- Email: daniel510791@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Experimental: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in texture score at visit 4 (follow-up session)
Time Frame: Group A: baseline and week 8; Group B: baseline and week 12
|
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)
Time Frame: Group A: baseline and week 8; Group B: baseline and week 12
|
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)
Time Frame: Group A: baseline and week 8; Group B: baseline and week 12
|
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)
Time Frame: Group A: baseline and week 8; Group B: baseline and week 12
|
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)
Time Frame: Group A: baseline and week 8; Group B: baseline and week 12
|
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)
Time Frame: Group A: baseline and week 8; Group B: baseline and week 12
|
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
Time Frame: Group A: baseline and week 2; Group B: baseline and week 4
|
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
Time Frame: Group A: baseline and week 2; Group B: baseline and week 4
|
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
Time Frame: Group A: baseline and week 2; Group B: baseline and week 4
|
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
Time Frame: Group A: baseline and week 2; Group B: baseline and week 4
|
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
Time Frame: Group A: baseline and week 2; Group B: baseline and week 4
|
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
Time Frame: Group A: baseline and week 2; Group B: baseline and week 4
|
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
Time Frame: Group A: baseline and week 4; Group B: baseline and week 8
|
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
Time Frame: Group A: baseline and week 4; Group B: baseline and week 8
|
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
Time Frame: Group A: baseline and week 4; Group B: baseline and week 8
|
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
Time Frame: Group A: baseline and week 4; Group B: baseline and week 8
|
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
Time Frame: Group A: baseline and week 4; Group B: baseline and week 8
|
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
Time Frame: Group A: baseline and week 4; Group B: baseline and week 8
|
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
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Adverse reaction after each treatment
Time Frame: Group A: week 2, week 4 and week 8; Group B: week4, week 8 and week 12
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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.
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Group A: week 2, week 4 and week 8; Group B: week4, week 8 and week 12
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Visual Analogue Scale (VAS) during treatment
Time Frame: Group A: week 0; Group B: week 0
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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".
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Group A: week 0; Group B: week 0
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Change from baseline in self-reported satisfaction with the skin around the eyes
Time Frame: Group A: baseline, week 2, week 4 and week 8; Group B: baseline, week4, week 8 and week 12
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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.
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Group A: baseline, week 2, week 4 and week 8; Group B: baseline, week4, week 8 and week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Yi-Hua Liao, MD/PhD, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2023
Primary Completion (Anticipated)
June 21, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
March 13, 2023
First Submitted That Met QC Criteria
March 30, 2023
First Posted (Actual)
April 13, 2023
Study Record Updates
Last Update Posted (Actual)
April 13, 2023
Last Update Submitted That Met QC Criteria
March 30, 2023
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 202207219DSC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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