Clinical trial NCT03948945: 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
Overall status: COMPLETED
Phase: NA
Conditions: Photoaging
Keywords: Fractional Laser
Photoaging
Treatment
Halo
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Air Force General Hospital of the PLA
name: First Hospital of China Medical University
name: Chinese Academy of Medical Sciences
First posted: 2019-05-14
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: VISIA skin test
timeFrame: change from week0 to week48
Secondary outcomes:
measure: Neck (Fitzpatrick wrinkle grading)
timeFrame: week0,week48
measure: Glogau Classification of Photoaging
timeFrame: change from week0 to week48
Other outcomes:
Locations:
Study officials:
affiliation: Dermatology Derpartment of Xijing Hospital
name: Gang Wang, Prof
role: PRINCIPAL_INVESTIGATOR
References: