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

NCT03962621 | Completed DMC

• 1 other identifier: XijingH-PF-20161117
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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. 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.

Conditions

Facial Rejuvenation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Multiprobe skin testing system

  change from week0 to week24

Study Arms (3)

2940 nm group

ACTIVE COMPARATOR

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

1064 nm group

ACTIVE COMPARATOR

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

Combined treatment group

EXPERIMENTAL

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; Radiation: Fotona 4D 2940 nm laser

Interventions

Fotona 4D 1064 nm laser RADIATION

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.

1064 nm group; Combined treatment group

Fotona 4D 2940 nm laser RADIATION

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

2940 nm group; Combined treatment group

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• xjpfW: lead
• Air Force General Hospital of the PLA: collaborator
• First Hospital of China Medical University: collaborator
• Chinese Academy of Medical Sciences: collaborator

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Gang Wang, Prof

  Dermatology Derpartment of Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Dermatology

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 24, 2019
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: May 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share