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

• ClinicalTrials.gov Identifier: NCT03962621
• Recruitment Status: Completed
• First Posted: May 24, 2019
• Last Update Posted: May 24, 2019
• Sponsor: xjpfW
• Collaborators: Air Force General Hospital of the PLA; First Hospital of China Medical University; Chinese Academy of Medical Sciences
• Information provided by (Responsible Party): xjpfW, Xijing Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Facial Rejuvenation	Radiation: Fotona 4D 1064 nm laser; Radiation: Fotona 4D 2940 nm laser	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of the Efficacy of a Non-ablative Erbium:YAG 2940nm in Combination With 1064nm Laser on Facial Rejuvenation
• Actual Study Start Date: January 1, 2017
• Actual Primary Completion Date: January 1, 2019
• Actual Study Completion Date: January 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 2940 nm group; Subjects were randomly assigned into two groups (n=10 per group) based on a treated with a Fotona 4D 2940 nm laser alone, the other side of face was treated with a Fotona 4D 2940 nm in combination with 1064 nm laser. The patients received three treatment sessions with monthly intervals between each session.	Radiation: 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
Active Comparator: 1064 nm group; Subjects were randomly assigned into two groups (n=10 per group) based on a treated with a Fotona 4D 1064 nm laser alone, the other side of face was treated with a Fotona 4D 2940 nm in combination with 1064 nm laser. The patients received three treatment sessions with monthly intervals between each session.	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.
Experimental: Combined treatment group; Subjects were randomly assigned into two groups (n=10 per group) based on a treated with a Fotona 4D 2940 nm or 1064 nm laser (Fotona, Slovenia, EU) alone, the other side of face was treated with a Fotona 4D 2940 nm in combination with 1064 nm laser. The patients received three treatment sessions with monthly intervals between each session.	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.; Radiation: 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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Multiprobe skin testing system [ Time Frame: change from week0 to week24 ]
   Multiprobe skin testing system (CK, Germany) is used to detect skin elasticity

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Sponsors and Collaborators

xjpfW

Air Force General Hospital of the PLA

First Hospital of China Medical University

Chinese Academy of Medical Sciences

Investigators

• Principal Investigator: Gang Wang, Prof; Dermatology Derpartment of Xijing Hospital

More Information

• Responsible Party: xjpfW, Head of Dermatology, Xijing Hospital
• ClinicalTrials.gov Identifier: NCT03962621
• Other Study ID Numbers: XijingH-PF-20161117
• First Posted: May 24, 2019
• Last Update Posted: May 24, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by xjpfW, Xijing Hospital:

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

Additional relevant MeSH terms:

Facies; Disease Attributes; Pathologic Processes