A Study of the Efficacy of Erbium:YAG 2940nm in Combination With 1064nm Laser on Facial Rejuvenation

Facial Rejuvenation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03962621
• Other study ID #: XijingH-PF-20161117
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: May 2019
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Facial Rejuvenation
• Facies

Intervention

Radiation:
• Fotona 4D 1064 nm laser
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.(1) Frac3®: 30-35 J/cm2, 1.6 ms pulse width, 4mm spot size, unilaterally accumulated 2000 shots; and (2) PIANO®: 160 J/cm2, 5s pulse width, spot size 9mm, unilaterally accumulated 20000 shots, to increase and maintain facial skin temperature to 39-40oC.
• Fotona 4D 2940 nm laser
Er:YAG 2940nm have been considered as a good treatment of facial aging, especially in wrinkles.(1) Smooth®: 9-10 J/cm2, 7mm spot size, which is sequentially delivered to upper and lower labial mucosa and buccal mucosa to unilaterally accumulate 5000 shots; (2) SupErficial™: 0.5-1.0 J/cm2, 7mm spot size, a single pass

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
xjpfW	Air Force General Hospital of the PLA, Chinese Academy of Medical Sciences, First Hospital of China Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visia CR imaging system	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	change from week0 to week24
Secondary	Multiprobe skin testing system	Multiprobe skin testing system (CK, Germany) is used to detect skin elasticity	change from week0 to week24