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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
xjpfW
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Photoaging focused on measuring Fractional Laser, Photoaging, Treatment, Halo

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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