Fraxel Laser for Skin Resurfacing

Recruiting at 4 trial locations

Overseen By Liz Santamaria

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Bausch Health Americas, Inc.

Must not be taking: Systemic steroids, Topical retinoids

Disqualifiers: Pregnancy, Skin cancer, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

50 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{5 6 7 8 9}

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

Written informed consent must be obtained prior to any study procedures

Ability to read, understand, and sign the informed consent form

I am either male or female.

Exclusion Criteria

Pregnant, breastfeeding, or planning to become pregnant during the study

History of any type of allergic reaction to topical anesthetics

Presence of skin conditions that, in the judgement of the investigator, would increase the risk of study participation or treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Fraxel FTX laser treatments for skin resurfacing

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Bausch Health Americas, Inc.

Lead Sponsor

Trials

265

Recruited

82,000+

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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2921736/

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07214272

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 ...

3. fraxel.com fraxel.com/

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 ...

4. ir.bauschhealth.com ir.bauschhealth.com/news-releases/2025/04-25-2025

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.

5. dermsurgery.net dermsurgery.net/top-7-benefits-of-fraxel-laser-skin-rejuvenation/

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 ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=22867159&pc=GEX

SOLTA 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=GEX

SOLTA 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 ...

8. fraxel.com fraxel.com/siteassets/hcp/pdf/fraxel-ftx-brochure.pdf

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: ...

9. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=22866855&pc=GEX

SOLTA 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 ...