A Randomized Controlled Trial of the Efficacy of a Non-ablative Erbium:YAG 2940nm in Combination With 1064nm Laser on Facial Rejuvenation

xjpfW0 sites20 target enrollmentJanuary 1, 2017

ConditionsFacial Rejuvenation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Facial Rejuvenation
Sponsor: xjpfW
Enrollment: 20
Primary Endpoint: Visia CR imaging system
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.
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.
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.

Registry

clinicaltrials.gov

Start Date

January 1, 2017

End Date

January 1, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

xjpfW

Responsible Party

Sponsor Investigator

Principal Investigator

xjpfW

Head of Dermatology

Xijing Hospital

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.

Outcomes

Primary Outcomes

Visia CR imaging system

Time Frame: change from week0 to week24

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, and elasticity