Clinical trial NCT03962621: A Study of the Efficacy of Erbium:YAG 2940nm in Combination With 1064nm Laser on Facial Rejuvenation
Official title: A Randomized Controlled Trial of the Efficacy of a Non-ablative Erbium:YAG 2940nm in Combination With 1064nm Laser on Facial Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Rejuvenation
Keywords: Facial rejuvenation, Erbium: YAG Laser, 1064 nm laser, skin aging
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: 2019-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 1. Facial aging is a progressive, multifactor-induced and multidimensional process which is naturally irreversible. The prominent clinical features of skin aging include loss of volume, pigmentation irregularity, low light reflectance, static and dynamic wrinkles, etc.
2. The development of superpulsed CO2 and Erbium: YAG 2940 nm resurfacing lasers was considered as the "gold standard" for the treatment of facial aging \[8,9\]. However, many drawbacks including intraoperative pain, post procedural erythema, edema, high risk of changes of pigmentation and long downtime have drawn concerns to patients and practitioners. Therefore, the facial rejuvenation therapies based on combined modalities to target various factors simutaneously have raised more and more interests.
3. The Fotona 4D laser platform incorporates the long pulsed 1064 nm and 2940 nm lasers, which provides versatile modalities to target various skin aging problems simultaneously. The 1064 nm laser can penetrate deep into the skin to explode pigment particles, destroy blood vessels and heat the dermal collagen by targeting melanin and haemoglobin. The 2940 nm Er:YAG laser in Fotona 4D system integrates a non-ablative Smooth® mode and cold peel SupErficial™ mode. the half-face treated by a 2940 nm laser alone showed a significant improvement on indexes of skin wrinkles, texture, pores and elasticity as compared to the baseline.


Eligibility criteria: Inclusion Criteria:

* Patients ranged in age from 35 to 60 years old.
* Patients had Dover scale between 2-4
* Fitzpatrick wrinkles scale between 1-3
* medium to very severe nasolabial fold depression with morphological scores of 2 - 3 points.

Exclusion Criteria:

* pregnancy,
* liver or kidney functional abnormality,
* skin ulceration
* skin cancer
* coagulation disorders
* patients on drugs of photosensitizing or anticoagulation agents
* systemic diseases such as cardiovascular disease, epilepsy, diabetes.

Primary outcomes:
measure: Visia CR imaging system
timeFrame: change from week0 to week24
Secondary outcomes:
measure: Multiprobe skin testing system
timeFrame: change from week0 to week24
Other outcomes:
Locations:
Study officials:
affiliation: Dermatology Derpartment of Xijing Hospital
name: Gang Wang, Prof
role: PRINCIPAL_INVESTIGATOR
References: