Fraxel Laser for Skin Resurfacing
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of the Fraxel Laser, a skin resurfacing treatment, for improving skin issues such as sun damage, wrinkles, and uneven skin tone. The researchers aim to assess the laser treatment's performance in a real-world setting and gather more information about its benefits and potential side effects. The trial is open to adults with noticeable signs of sun damage, mild to moderate wrinkles around the eyes, or uneven skin tone on their face, who are willing to avoid excessive sun exposure during the study. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance skin treatment options.
Do I have to stop taking my current medications for the trial?
You may need to stop certain medications before joining the trial. Specifically, you cannot use systemic steroids or immunosuppressants within 1 month before or during the study, topical retinoids within 2 weeks, or systemic retinoids within 6 months. Check with the study team about other medications you are taking.
What is the safety track record for the Fraxel® FTX Laser System?
Research shows that the Fraxel® FTX Laser System is generally safe for skin resurfacing, though some side effects may occur. Studies have found that users might experience temporary redness and skin darkening (hyperpigmentation) after treatment. These effects are usually mild and resolve over time.
Proper use of the Fraxel laser is crucial, as incorrect use can cause injury. Therefore, trained professionals should always perform treatments. Despite these concerns, the device is widely used and functions as intended without mechanical issues during treatments. Since this treatment is in the post-marketing (Phase 4) stage, it has already been approved for use, and its safety is monitored in real-world settings.12345Why are researchers enthusiastic about this study treatment?
The Fraxel® FTX Laser System is unique because it uses fractional laser technology to target specific areas of skin, promoting collagen production and skin resurfacing without damaging surrounding tissue. Unlike traditional methods like chemical peels or dermabrasion, which remove entire layers of skin, Fraxel works by creating tiny, controlled micro-injuries to the skin, allowing for quicker healing and less downtime. Researchers are excited about this treatment because it offers a more precise approach with the potential for improved results and reduced recovery time, making it a promising option for skin resurfacing.
What is the effectiveness track record for the Fraxel® FTX Laser System for skin resurfacing?
Research has shown that the Fraxel FTX Laser System effectively improves skin. One study found a 34% reduction in wrinkles and a 47% improvement in skin texture after three months of treatment. This trial will evaluate the Fraxel FTX Laser System, which also enhances skin tone, texture, and brightness, particularly for aging, sun-damaged, or scarred skin. Fraxel is known for reducing sun damage, wrinkles, acne scars, and uneven skin color. It gradually smooths fine lines, giving the skin a younger and refreshed appearance.56789
Are You a Good Fit for This Trial?
This trial is for adults aged 21-60 with skin issues like photodamage, wrinkles, or discoloration. Participants must be able to consent and not pregnant, allergic to anesthetics, prone to scarring, have recent infections or certain skin conditions (melasma, rosacea), immune disorders, light sensitivity due to medications or conditions. They shouldn't have had recent cosmetic procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Fraxel FTX laser treatments for skin resurfacing
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fraxel® FTX Laser System
Trial Overview
The study tests the Fraxel® FTX Laser System's effectiveness and safety in treating skin damage. It's a Phase 4 trial where all participants receive the same laser treatment under observation without being compared to other treatments or placebos.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bausch Health Americas, Inc.
Lead Sponsor
Dr. Jonathan Sadeh
Bausch Health Americas, Inc.
Chief Medical Officer
MD from Mount Sinai School of Medicine, MSc in Clinical Research from Harvard Medical School
Thomas J. Appio
Bausch Health Americas, Inc.
Chief Executive Officer since 2021
Bachelor's degree in Biology from Rutgers University
Citations
Update on Fractional Laser Technology - PMC
At three months, they found 34-percent improvement in wrinkles and 47-percent improvement in skin texture. Geronemus reported Fraxel improved fine-to-moderate ...
NCT07214272 | A Phase 4 Clinical Study to Investigate the ...
A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing ... Treatment Arm, Intervention/Treatment, Device : Fraxel® FTX Laser ...
Fraxel | Skin Resurfacing Treatment
Fraxel treatment improves tone, texture and radiance for aging, sun-damaged or scarred skin. Fraxel is for people who want to look younger without dramatic ...
Bausch Health Announces Launch of Solta Medical's ...
Fraxel is a leading treatment in skin rejuvenation, addressing common skin concerns such as sun damage, wrinkles, acne scars, and pigmentation irregularities.
Top 7 Benefits of Fraxel Laser Skin Rejuvenation
This results in a gradual smoothing of fine lines and wrinkles, giving the skin a more youthful and refreshed appearance. Unlike more invasive ...
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accessdata.fda.gov
accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=22867159&pc=GEXSOLTA MEDICAL, INC. FRAXEL FTX LASER SYSTEM
A user facility reported hyperpigmentation and redness in the cheek area 8 weeks post fraxel ftx treatment.Approximately four days after a ...
7.
accessdata.fda.gov
accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=22610700&pc=GEXSOLTA MEDICAL, INC. FRAXEL FTX LASER SYSTEM
A review of the data logs from the event showed that no errors occurred during treatment and the device functioned as designed. The ...
fraxel-ftx-brochure.pdf
Improper use of Fraxel® may cause personal injury or damage to the system. Adverse Events. • The following may be associated with Fraxel® laser treatment: ...
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accessdata.fda.gov
accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=22866855&pc=GEXSOLTA MEDICAL, INC. FRAXEL FTX LASER SYSTEM
Post-inflammatory hypopigmentation and hyperpigmentation are known complications of many laser treatments and may occur with the fraxel laser ...
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