Efficacy and Safety of Profile HaloTM Mixed Fractional Laser on Treating of Facial and Neck Photoaging.
Primary Purpose
Photoaging
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Profile HaloTM Mixed Fractional Laser
Sponsored by
About this trial
This is an interventional treatment trial for Photoaging focused on measuring Fractional Laser, Photoaging, Treatment, Halo
Eligibility Criteria
Inclusion Criteria:
- Subjects must be clinically diagnosed by the investigator to facial photoaging dover 2-4 and cervical stripe Fitzpatrick 1-2.5
- no other treatment was performed for the skin lesions for half a year before the treatment
- patients with a "no" in any of the above criteria are not eligible for inclusion
Exclusion Criteria:
- subjects with a recent history of exposure to sunlight;
- subjects allergic to topical anesthesia;
- subjects with scar constitution;
- subjects with skin malignant tumors or precancerous lesions; .subjects with diabetes, heart disease, epilepsy, connective tissue disease, etc.
- subjects who Pregnant or breast feeding;
- subjects with recent skin infections (such as viruses, bacteria, etc.);
- ther methods are being used to treat subjects with similar diseases;
- subject who have taken isotretinoin A in the past year; .subject with facial dermatitis.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
before treatment
after treatment
Arm Description
The patient with facial and neck photoaging did not receive laser treatment.
The patient with facial and neck photoaging received Profile HaloTM mixed fractional laser treatment
Outcomes
Primary Outcome Measures
VISIA skin test
With fast capture times and lighting modes designed to enhance the visualization of skin features, VISIA®-CR (Canfield Scientific, Inc. USA) is the standard in repeatable clinical imaging. Visia CR imaging system can be used to assess the skin wrinkles, texture, pores and elasticity
Secondary Outcome Measures
Neck (Fitzpatrick wrinkle grading)
Level 0: no wrinkles, no visible wrinkles and continuous skin lines; Level 0.5: very shallow wrinkles visible to the naked eye Level 1: fine wrinkles, slight depressions visible to naked eye Level 1.5: visible wrinkles and clear depressions with a depth of <0.01mm; Level 2: medium wrinkles. It can be clearly seen that the depth of wrinkles is 1-2mm.
Level 2.5: obvious visible wrinkles with a depth of 2-3mm; Level 3: deep wrinkles, visible deep marks, depth greater than > 3mm
Glogau Classification of Photoaging
I: Mild 28-35 years old No wrinkles Early Photoaging: mild pigment changes, no keratosis, minimal wrinkles, minimal or no makeup; II: Moderate 35-50 years old Wrinkles in motion Early to Moderate Photoaging: Early brown spots visible, keratosis palpable but not visible, parallel smile lines begin to appear, wears some foundation; III: Advanced 50-65 years old Wrinkles at rest Advanced Photoaging: Obvious discolorations, visible capillaries (telangiectasias), visible keratosis, wears heavier foundation always; IV: Severe 60-75 years old Only wrinkles Severe Photoaging: Yellow-gray skin color, prior skin malignancies, wrinkles throughout-no normal skin, cannot wear makeup because it cakes and cracks
Full Information
NCT ID
NCT03948945
First Posted
May 10, 2019
Last Updated
May 11, 2019
Sponsor
xjpfW
Collaborators
Air Force General Hospital of the PLA, First Hospital of China Medical University, Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03948945
Brief Title
Efficacy and Safety of Profile HaloTM Mixed Fractional Laser on Treating of Facial and Neck Photoaging.
Official Title
Efficacy and Safety of Profile HaloTM Dual-wavelength Fusion Fractional Laser on the Treatment of Facial and Neck Photoaging: a Self-controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
October 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
xjpfW
Collaborators
Air Force General Hospital of the PLA, First Hospital of China Medical University, Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Fractional laser has become an important laser modality in management of a number of skin conditions and photoaging. Fractional photothermolysis is the fractional emission of light into microscopic treatment zones, creating small columns of injury to the skin in a pixilated fashion. Epidermal and dermal disruptions occur in these focal zones of thermal injury, stimulating dermal collagen production and elastic tissue formation. Fractional laser has been used successfully to treat photodamage and overall dyschromia in the Caucasian population. However, there is not much improvement in Asian population.
Photoaging refers to the skin caused by intense and chronic exposure to sunlight. The visible effects of photoaging are fine wrinkles, mottling, pigmentation and roughness of the skin. These changes are usually associated with chronologic aging. However, photoaging is not a good indicator of chronologic age. It just makes a person look older than his or her chronologic age. Skin ageing may be divided into two processes: intrinsic ageing and extrinsic ageing (or photoageing). Both are accompanied by changes in the morphological and biomechanical properties of skin.
Profile HaloTM dual-wavelength fusion fractional laser is the first hand tool in the world that integrates ablative and non-ablative fractional lasers. It includes a non-ablative fractional laser with a wavelength of 1470nm and an ablative fractional laser with a wavelength of 2940nm. A day after treatment, new epithelial tissue began to appear, and the necrotic epidermis formed microepidermal necrotic debris (MENDs). MENDs were surrounded by keratin 2-7 days after treatment, and collagen sequence in MTZs was changed 7 days later. The 2940 ablative fractional laser can be added with 20-100 micron lattice stripping, ensuring safety while enabling MENDs to be peeled off 2 days earlier and reducing the risk of side effects. This makes the laser safe and effective compared with the single fractional laser and reduces the downtime.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photoaging
Keywords
Fractional Laser, Photoaging, Treatment, Halo
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
before treatment
Arm Type
No Intervention
Arm Description
The patient with facial and neck photoaging did not receive laser treatment.
Arm Title
after treatment
Arm Type
Experimental
Arm Description
The patient with facial and neck photoaging received Profile HaloTM mixed fractional laser treatment
Intervention Type
Radiation
Intervention Name(s)
Profile HaloTM Mixed Fractional Laser
Intervention Description
Profile HaloTM fractional laser is the world's first hand tool with nonablative and ablative fractional laser. It includes a nonablative fractional laser with a wavelength of 1470 nm and an ablative fractional laser with a wavelength of 2940 nm. It has a good therapeutic effect on skin aging.
Primary Outcome Measure Information:
Title
VISIA skin test
Description
With fast capture times and lighting modes designed to enhance the visualization of skin features, VISIA®-CR (Canfield Scientific, Inc. USA) is the standard in repeatable clinical imaging. Visia CR imaging system can be used to assess the skin wrinkles, texture, pores and elasticity
Time Frame
change from week0 to week48
Secondary Outcome Measure Information:
Title
Neck (Fitzpatrick wrinkle grading)
Description
Level 0: no wrinkles, no visible wrinkles and continuous skin lines; Level 0.5: very shallow wrinkles visible to the naked eye Level 1: fine wrinkles, slight depressions visible to naked eye Level 1.5: visible wrinkles and clear depressions with a depth of <0.01mm; Level 2: medium wrinkles. It can be clearly seen that the depth of wrinkles is 1-2mm.
Level 2.5: obvious visible wrinkles with a depth of 2-3mm; Level 3: deep wrinkles, visible deep marks, depth greater than > 3mm
Time Frame
week0,week48
Title
Glogau Classification of Photoaging
Description
I: Mild 28-35 years old No wrinkles Early Photoaging: mild pigment changes, no keratosis, minimal wrinkles, minimal or no makeup; II: Moderate 35-50 years old Wrinkles in motion Early to Moderate Photoaging: Early brown spots visible, keratosis palpable but not visible, parallel smile lines begin to appear, wears some foundation; III: Advanced 50-65 years old Wrinkles at rest Advanced Photoaging: Obvious discolorations, visible capillaries (telangiectasias), visible keratosis, wears heavier foundation always; IV: Severe 60-75 years old Only wrinkles Severe Photoaging: Yellow-gray skin color, prior skin malignancies, wrinkles throughout-no normal skin, cannot wear makeup because it cakes and cracks
Time Frame
change from week0 to week48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must be clinically diagnosed by the investigator to facial photoaging dover 2-4 and cervical stripe Fitzpatrick 1-2.5
no other treatment was performed for the skin lesions for half a year before the treatment
patients with a "no" in any of the above criteria are not eligible for inclusion
Exclusion Criteria:
subjects with a recent history of exposure to sunlight;
subjects allergic to topical anesthesia;
subjects with scar constitution;
subjects with skin malignant tumors or precancerous lesions; .subjects with diabetes, heart disease, epilepsy, connective tissue disease, etc.
subjects who Pregnant or breast feeding;
subjects with recent skin infections (such as viruses, bacteria, etc.);
ther methods are being used to treat subjects with similar diseases;
subject who have taken isotretinoin A in the past year; .subject with facial dermatitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Wang, Prof
Organizational Affiliation
Dermatology Derpartment of Xijing Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy and Safety of Profile HaloTM Mixed Fractional Laser on Treating of Facial and Neck Photoaging.
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