Fractional Ablative Laser Treatment for Loose Skin

Overseen By Jason Pozner, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sciton

Must not be taking: Anticoagulants, Immunosuppressants

Disqualifiers: Diabetes, Cardiovascular disease, Immunosuppression, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a fractional ablative laser, a type of laser treatment, for tightening loose skin. Individuals with visible loose skin or scars who can follow treatment guidelines and permit the use of images of their treatment area for educational purposes may be suitable candidates. Participants should not have undergone prior cosmetic treatments in the target area and must not have any skin issues, such as cuts or moles, in the treatment area. As an unphased trial, this study offers participants the chance to contribute to innovative research and potentially benefit from cutting-edge treatment.

Do I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking prescription anticoagulation or immunosuppressive medications, you may be excluded from participating.

What prior data suggests that this fractional ablative laser is safe for treating skin laxity?

Research has shown that fractional ablative lasers are generally safe and well-tolerated for skin treatments. Past studies found these lasers cause only minor side effects and deliver reliable results with less recovery time compared to older methods. For instance, one study found that fractional CO2 lasers effectively rejuvenate the skin with fewer complications. Another study confirmed that using specific settings for depth and energy during treatments can safely produce consistent results. Overall, this evidence suggests that fractional ablative lasers are a safe choice for skin tightening treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for loose skin, like topical creams or surgical procedures, focus on either skincare ingredients or invasive interventions. However, fractional ablative laser treatment is unique because it uses laser energy to create controlled micro-injuries in the skin. This process stimulates the body’s natural healing response, leading to tighter and firmer skin without the need for surgery. Researchers are excited about this treatment because it offers a non-invasive alternative with potentially faster recovery times and long-lasting results compared to traditional methods.

What evidence suggests that the fractional ablative laser is effective for skin laxity?

Research has shown that fractional ablative laser treatments, which participants in this trial will receive, effectively tighten and firm the skin. One study found that this treatment improved neck skin firmness by an average of 57% within two months. Another report highlighted significant improvements in skin tone, texture, and tightness after using the laser. This method is popular because it provides noticeable results with minimal recovery time and few side effects. Overall, fractional ablative lasers are well-regarded for rejuvenating and tightening skin effectively. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with loose skin or scars who can follow the treatment plan and are not pregnant. They must have no major illnesses, bleeding disorders, abnormal scarring history, recent cosmetic treatments in the area, cancer treatments, immune issues, or participation in other trials recently.

Inclusion Criteria

Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions

People with any skin type from very fair to very dark.

Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study (Applicable to female subjects only)

Exclusion Criteria

As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

You have a serious health condition like uncontrolled high blood pressure or diabetes.

You have a blood clotting problem or are taking blood-thinning medications prescribed by a doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fractional ablative laser treatment for skin laxity and tightening

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Fractional Ablative Laser

Trial Overview

The study tests how safe and effective a fractional ablative laser is at tightening skin. Participants will undergo laser treatment on their affected skin areas and then be monitored to see how well it works and what side effects occur.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Patients will receive fractional ablative treatment for laxity.

Fractional Ablative Laser is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Fraxel Re:pair for:

• Skin laxity
• Skin tightening
• Scars
• Wrinkles
• Photodamage
• Sun damage
• Textural improvement

Approved in European Union as Fraxel Re:pair for:

• Skin laxity
• Skin tightening
• Scars
• Wrinkles
• Photodamage
• Sun damage
• Textural improvement

Approved in Canada as Active FX for:

• Skin laxity
• Skin tightening
• Fine lines
• Photodamage

Approved in Japan as Deep FX for:

• Deep lines and wrinkles
• Sunspots and age spots
• Uneven skin tone and texture
• Hyperpigmentation
• Scarring
• Melasma

Who Is Running the Clinical Trial?

Sciton

Lead Sponsor

Trials

20

Recruited

1,400+

Published Research Related to This Trial

Fractional photothermolysis using the Fraxel laser effectively improves skin color and texture, reduces fine wrinkles, and decreases unwanted pigmentation with minimal downtime for patients, as demonstrated in a study of 70 patients undergoing 2 to 6 treatments.

Patients experienced only mild side effects like redness and swelling for a few days, followed by light skin exfoliation, indicating a safe and well-tolerated procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fraxel skin resurfacing. Collawn, SS.[2007]

Fractional laser treatment using the 1,550 nm erbium fiber laser effectively targets skin aging signs by creating microscopic thermal zones that promote skin remodeling without damaging the epidermis.

This treatment can address various skin issues, including pigmentation, melasma, wrinkles, and scars, while offering limited downtime for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional Laser treatment for pigmentation and texture improvement. Rahman, Z., Alam, M., Dover, JS.[2015]

The Fraxel laser procedure offers a safe and effective method for reducing wrinkles and improving skin texture, with results comparable to traditional CO2 and erbium lasers but with less downtime and fewer risks.

In a study involving 150 patients and 600 treatment sessions, no severe side effects were reported, and the average recovery time included only 2 days of erythema and 2-4 days of edema, making it a viable option for facial rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fractional photo-thermolysis by laser Fraxel as an adjuvant for facial surgical rejuvenation]. Buis, J., Mazer, JM.[2007]

Fractional photothermolysis (FPT) using a 1550 nm non-ablative erbium laser effectively treated a depressed facial scar in a 49-year-old woman, making it nearly imperceptible after five treatments over 20 weeks.

This case suggests that FPT may be a promising option for improving scars resulting from Mohs micrographic surgery, with lasting results observed 18 months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional photothermolysis improves a depressed alar scar following Mohs micrographic surgery. Schulz, KK., Walling, HW.[2015]

In a study of 373 CO₂ laser treatments on 287 patients, adverse events (AEs) occurred in 12.6% of treatments, with the most common being allergic dermatitis (4.6%) and acneiform breakouts (3.5%).

The risk of AEs increased significantly when multiple body areas were treated simultaneously, with 37.5% of patients experiencing AEs when three areas were treated, while subsequent treatments on the same area after healing showed no increased risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of fractionated carbon dioxide laser: review of 373 treatments. Campbell, TM., Goldman, MP.[2012]

Ablative fractional CO₂ laser resurfacing using the Fraxel Re:pair device showed statistically significant improvements in skin texture, laxity, wrinkles, enlarged pores, and acne scars in a study of nine Asian patients, indicating its efficacy for skin rejuvenation.

Despite the overall satisfaction rate of 86% among patients, the treatment had a high post-inflammatory hyperpigmentation rate of 55.5% shortly after treatment, suggesting a need for caution and further evaluation of its safety compared to non-ablative treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional ablative carbon dioxide laser resurfacing for skin rejuvenation and acne scars in Asians. Chan, NP., Ho, SG., Yeung, CK., et al.[2022]

A study involving 41 patients demonstrated that combined fractional carbon dioxide (FCL) and radiofrequency (FRFL) laser treatment significantly reduced acne scar severity, particularly for atrophic scars, as assessed by clinical scoring after one month.

The treatment was found to be effective and well-tolerated, with minimal and acceptable side effects, indicating it is a safe option for improving acne scars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of fractional carbondioxyde laser and microneedle radiofrequency on acne scars. Canpolat, F., Koc, E., Kartal, SP.[2022]

Newer fractional laser technologies, which do not require tracking dye and create shallower microtreatment zones, are less painful and more effective for treating photoaged skin compared to older models.

In a study involving 16 Caucasian females, just 1 to 3 treatments with the new combination fractional laser device led to noticeable improvements in periocular wrinkles and skin laxity, demonstrating its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early improvement in rhytides and skin laxity following treatment with a combination fractional laser emitting two wavelengths sequentially. Foster, KW., Kouba, DJ., Fincher, EE., et al.[2016]

A study involving 44 Chinese patients with acne scars demonstrated that combining conventional CO2 laser and fractional CO2 laser treatments resulted in a significant average improvement of 52.5% in acne scars after multiple sessions, with 64% of patients showing 51-75% improvement.

The combined laser treatment was found to be safe, with mild to moderate side effects, including temporary post-inflammatory hyperpigmentation in about 50% of patients, but did not increase the risk of complications compared to other laser therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new modality for fractional CO2 laser resurfacing for acne scars in Asians. Huang, L.[2022]

In a study of 119 Asian patients treated with fractional erbium fiber laser, only 3.3% experienced complications, indicating that the treatment is generally safe for this skin type.

The most common side effect was postinflammatory hyperpigmentation at 2.2%, and notably, no herpes outbreaks occurred despite the lack of prophylaxis, suggesting that herpes prevention may not be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects and complications of fractional 1550-nm erbium fiber laser treatment among Asians. Vaiyavatjamai, P., Wattanakrai, P.[2022]

In a study of 87 patients with moderate to severe acne scars treated with nonablative fractional photothermolysis using a 1540-nm Erbium glass fiber laser, 92% of patients experienced marked improvement six months after treatment.

The treatment was found to be safe and effective, as it promoted the replacement of coarse collagen with healthier collagen similar to that found in normal skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonablative fractional photothermolysis for acne scars: clinical and in vivo microscopic documentation of treatment efficacy. Bencini, PL., Tourlaki, A., Galimberti, M., et al.[2022]

Both fractional CO2 laser devices (rolling and stamping handpieces) were found to be safe and effective for treating photodamaged facial skin, with all eight subjects showing improvement after 3 months.

There were no significant differences in overall improvement ratings between the two devices, although the stamping handpiece resulted in longer procedure times and higher pain ratings during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A split-face comparison of two ablative fractional carbon dioxide lasers for the treatment of photodamaged facial skin. Ciocon, DH., Engelman, DE., Hussain, M., et al.[2012]

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Wrinkles, acne scarring, sun damage, and melasma (the "mask of pregnancy") may all be improved with this laser therapy. The result is smoother, fresher, more ...

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Ablative Laser Therapy of Skin

Using treatment parameters that combine depth of injury, energy of ablation, and density can pro- vide safe and reliable treatments and consistent outcomes.