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

NCT ID: NCT03962621

Last Updated: 2019-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-01-01

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.

Conditions

Facial Rejuvenation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Fotona 4D 2940 nm laser

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Fotona 4D 1064 nm laser

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Fotona 4D 1064 nm laser

Intervention Type: 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.

Fotona 4D 2940 nm laser

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force General Hospital of the PLA

OTHER_GOV

Sponsor Role: collaborator

First Hospital of China Medical University

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

xjpfW

OTHER

Sponsor Role: lead

Responsible Party

xjpfW

Head of Dermatology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gang Wang, Prof

Role: PRINCIPAL_INVESTIGATOR

Dermatology Derpartment of Xijing Hospital

Other Identifiers

XijingH-PF-20161117

Identifier Type: -

Identifier Source: org_study_id