Facial RejuvenationNCT03962621
A Study of the Efficacy of Erbium:YAG 2940nm in Combination With 1064nm Laser on Facial Rejuvenation
A study testing Fotona 4D 1064 nm laser and Fotona 4D 2940 nm laser in people with Facial Rejuvenation, run by xjpfW.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Facial Rejuvenation
- What is being tested?
- Fotona 4D 1064 nm laser and Fotona 4D 2940 nm laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A Randomized Controlled Trial of the Efficacy of a Non-ablative Erbium:YAG 2940nm in Combination With 1064nm Laser on Facial Rejuvenation
- 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.
- 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.
- 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
- Being tested
- Fotona 4D 1064 nm laser, Fotona 4D 2940 nm laser
- Keywords
- Facial rejuvenation, Erbium: YAG Laser, 1064 nm laser, skin aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fotona 4D 1064 nm laserRadiation
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 laserRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Radiation: Fotona 4D 1064 nm laser; Radiation: Fotona 4D 2940 nm laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change from week0 to week24
Secondary outcomes (1)
Multiprobe skin testing system
Multiprobe skin testing system (CK, Germany) is used to detect skin elasticity
Measured: change from week0 to week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start1 Jan 2017
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial RejuvenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- xjpfW
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force General Hospital of the PLA, First Hospital of China Medical University, Chinese Academy of Medical Sciences
- Responsible party
- Sponsor-investigator, xjpfW, Xijing Hospital
- Investigators
- Gang Wang, Prof, Principal investigator, Dermatology Derpartment of Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962621
- Sponsor's protocol ID
- XijingH-PF-20161117
- Status last verified
- May 2019
- First submitted
- 10 May 2019
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Efficacy of a Non-ablative Erbium:YAG 2940nm in Combination With 1064nm Laser on Facial Rejuvenation
- ClinicalTrials.gov ID
- NCT03962621
- Acronym / sponsor ID
- XijingH-PF-20161117
- Conditions
- Facial Rejuvenation
- Keywords
- Facial rejuvenation, Erbium: YAG Laser, 1064 nm laser, skin aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- xjpfWUniversity, hospital or other
- Collaborators
- Air Force General Hospital of the PLA, First Hospital of China Medical University, Chinese Academy of Medical Sciences
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2940 nm group | Active comparator | Radiation: Fotona 4D 2940 nm laserSubjects 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. |
| 1064 nm group | Active comparator | Radiation: Fotona 4D 1064 nm laserSubjects 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. |
| Combined treatment group | Experimental | Radiation: Fotona 4D 1064 nm laser, Radiation: Fotona 4D 2940 nm laserSubjects 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. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- pregnancy,
- liver or kidney functional abnormality,
- skin ulceration
- skin cancer
- coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fotona 4D 1064 nm laserThe 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 | 1064 nm group, Combined treatment group |
| Fotona 4D 2940 nm laserEr: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 | Radiation | 2940 nm group, Combined treatment group |
Primary outcome
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
1 secondary outcome
Multiprobe skin testing system
Time frame: change from week0 to week24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Wang, Prof principal investigator
Dermatology Derpartment of Xijing Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Fotona 4D 1064 nm laser and Fotona 4D 2940 nm laser in people with Facial Rejuvenation, run by xjpfW.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visia CR imaging system (time frame: change from week0 to week24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.