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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03962621
Enrollment
20
Registered
2019-05-24
Start date
2017-01-01
Completion date
2019-01-01
Last updated
2019-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Rejuvenation

Keywords

Facial rejuvenation, Erbium: YAG Laser, 1064 nm laser, skin aging

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.

Interventions

RADIATIONFotona 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.

RADIATIONFotona 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

Sponsors

Air Force General Hospital of the PLA
CollaboratorOTHER_GOV
First Hospital of China Medical University
CollaboratorOTHER
Chinese Academy of Medical Sciences
CollaboratorOTHER
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Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visia CR imaging systemchange from week0 to week24With 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

Secondary

MeasureTime frameDescription
Multiprobe skin testing systemchange from week0 to week24Multiprobe skin testing system (CK, Germany) is used to detect skin elasticity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026