Efficacy and Safety of Profile HaloTM Mixed Fractional Laser on Treating of Facial and Neck Photoaging.

• ClinicalTrials.gov Identifier: NCT03948945
• Recruitment Status: Completed
• First Posted: May 14, 2019
• Last Update Posted: May 14, 2019
• Sponsor: xjpfW
• Collaborators: Air Force General Hospital of the PLA; First Hospital of China Medical University; Chinese Academy of Medical Sciences
• Information provided by (Responsible Party): xjpfW, Xijing Hospital

Study Description

Brief Summary:

1. 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.
2. 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.
3. 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.

Condition or disease	Intervention/treatment	Phase
Photoaging	Radiation: Profile HaloTM Mixed Fractional Laser	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: October 1, 2015
• Actual Primary Completion Date: October 1, 2017
• Actual Study Completion Date: October 1, 2017

Arms and Interventions

Arm	Intervention/treatment
No Intervention: before treatment; The patient with facial and neck photoaging did not receive laser treatment.
Experimental: after treatment; The patient with facial and neck photoaging received Profile HaloTM mixed fractional laser treatment	Radiation: Profile HaloTM Mixed Fractional Laser; 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.

Outcome Measures

Primary Outcome Measures :

1. VISIA skin test [ Time Frame: change from week0 to week48 ]
   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 :

1. Neck (Fitzpatrick wrinkle grading) [ Time Frame: week0,week48 ]

   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

2. Glogau Classification of Photoaging [ Time Frame: change from week0 to week48 ]
   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

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Sponsors and Collaborators

xjpfW

Air Force General Hospital of the PLA

First Hospital of China Medical University

Chinese Academy of Medical Sciences

Investigators

• Principal Investigator: Gang Wang, Prof; Dermatology Derpartment of Xijing Hospital

More Information

• Responsible Party: xjpfW, Head of Dermatology, Xijing Hospital
• ClinicalTrials.gov Identifier: NCT03948945
• Other Study ID Numbers: XijingH-PF-20150705
• First Posted: May 14, 2019
• Last Update Posted: May 14, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by xjpfW, Xijing Hospital:

Fractional Laser; Photoaging; Treatment; Halo

Additional relevant MeSH terms:

Skin Diseases