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

xjpfW

Status: Completed

Conditions: Facial Rejuvenation

Treatments: Radiation: Fotona 4D 1064 nm laser; Radiation: Fotona 4D 2940 nm laser

Study type: Interventional

Funder types: Other

Identifiers

NCT03962621

XijingH-PF-20161117

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 35 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

20 participants in 3 patient groups

2940 nm group

Active Comparator group

Description:

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.

Treatment:

Radiation: Fotona 4D 2940 nm laser

1064 nm group

Active Comparator group

Description:

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.

Treatment:

Radiation: Fotona 4D 1064 nm laser

Combined treatment group

Experimental group

Description:

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.

Treatment:

Radiation: Fotona 4D 2940 nm laser

Radiation: Fotona 4D 1064 nm laser