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

Trial Summary

What is the purpose of this trial?

Evaluate the safety and efficacy of the fractional ablative laser for treatment of skin laxity and tightening

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 data supports the idea that Fractional Ablative Laser Treatment for Loose Skin is an effective treatment?

The available research shows that Fractional Ablative Laser Treatment is effective for improving skin laxity and reducing wrinkles. One study highlights that newer fractional lasers are less painful and more effective in treating facial wrinkles and loose skin by using two laser wavelengths. Another study found that this treatment improved skin color and texture, reduced fine wrinkles, and had minimal downtime. Although some studies focus on other conditions like acne scars, they also demonstrate the treatment's effectiveness in improving skin appearance. ^{1 2 3 4 5}

What safety data is available for fractional ablative laser treatments for loose skin?

The safety data for fractional ablative laser treatments, including devices like Fraxel Re:pair and Fractional CO2 Laser, indicate that these treatments are generally safe with minimal severe side effects. Studies have shown that adverse events are infrequent, with some cases of limited erosion and temporary erythema and edema. The treatments are effective for reducing wrinkles and improving skin texture, with no severe side effects or dyschromia reported in a study involving 150 patients. Overall, fractional ablative laser treatments are considered safe and effective for skin rejuvenation. ^{6 7 8 9 10}

Is Fractional Ablative Laser Treatment a promising treatment for loose skin?

Yes, Fractional Ablative Laser Treatment is promising for loose skin. It improves skin texture and reduces wrinkles with minimal downtime. It uses advanced technology to treat skin effectively and safely, making it a popular choice for skin rejuvenation. ^{1 4 5 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Early improvement in rhytides and skin laxity following treatment with a combination fractional laser emitting two wavelengths sequentially. [2016]

2. England pubmed.ncbi.nlm.nih.gov

The effectiveness of fractional carbondioxyde laser and microneedle radiofrequency on acne scars. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Fractional photothermolysis improves a depressed alar scar following Mohs micrographic surgery. [2015]

4. Canada pubmed.ncbi.nlm.nih.gov

Fractional Laser treatment for pigmentation and texture improvement. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Fraxel skin resurfacing. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

A split-face comparison of two ablative fractional carbon dioxide lasers for the treatment of photodamaged facial skin. [2012]

7. France pubmed.ncbi.nlm.nih.gov

[Fractional photo-thermolysis by laser Fraxel as an adjuvant for facial surgical rejuvenation]. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse events of fractionated carbon dioxide laser: review of 373 treatments. [2012]

9. England pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Nonablative fractional photothermolysis for acne scars: clinical and in vivo microscopic documentation of treatment efficacy. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Fractional ablative carbon dioxide laser resurfacing for skin rejuvenation and acne scars in Asians. [2022]

12. England pubmed.ncbi.nlm.nih.gov

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