Hybrid Fractional Laser for Acne Scars

Overseen By Anika Jallorina, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Must not be taking: Immunosuppressives, Retinoids

Disqualifiers: Active acne, Keloidal scarring, Immunosuppression, others

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

Compensation: Varies

Number of Visits: 6

Duration: 3 months

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of laser treatment to evaluate its effectiveness in reducing acne scars, particularly in individuals with darker skin tones. The study explores two types of laser treatments, each involving three sessions with the Sciton Halo hybrid fractional laser. It suits those who have had visible acne scars for at least six months and have not smoked or vaped in the past year. Participants will receive sun care advice and may be given a cream to use before starting the laser sessions. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance treatment options for acne scars.

Will I have to stop taking my current medications?

The trial requires that you have not used immunosuppressive medications, biologics, or Accutane (or other systemic retinoids) in the past 6 to 12 months. If you are currently taking these, you would need to stop before participating.

What prior data suggests that this hybrid fractional laser is safe for treating acne scars?

Research has shown that the Sciton Halo hybrid fractional laser is generally well-tolerated. In a study with 29 participants, 80% experienced noticeable skin improvement. The treatment causes minimal discomfort, with low average pain scores reported.

This laser provides results without the long recovery time often needed with other laser treatments. However, like any procedure, some side effects may occur, such as temporary redness, swelling, or mild skin irritation, but these usually resolve quickly.

The Sciton Halo has been used for other skin treatments, indicating it is generally safe. Participants in previous studies reported positive experiences, making it a promising option for those considering treatment for acne scars. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Hybrid Fractional Laser treatment for acne scars because it combines the benefits of ablative and non-ablative lasers, maximizing skin resurfacing while minimizing downtime. Unlike other treatments like chemical peels or dermabrasion, which can be more invasive, this method targets both the surface and deeper layers of the skin to promote collagen production and improve skin texture. The Sciton Halo laser specifically allows for customizable treatment settings, making it adaptable to different skin types and scar severities, which could lead to more personalized and effective results.

What evidence suggests that this trial's treatments could be effective for acne scars?

Research has shown that the Sciton Halo hybrid fractional laser, which participants in this trial will receive, can effectively improve acne scars. One study found that individuals with mild-to-moderate acne scars experienced about a 50% improvement after treatment. This treatment uses two types of lasers—one targeting the surface and one penetrating deeper—to treat the skin more thoroughly without long recovery times. This combination helps smooth out acne scars. Early results also suggest that the laser is well-tolerated by people with different skin types. ^{1 4 5 6 7}

Who Is on the Research Team?

Kseniya Kobets, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a history of acne scarring who are seeking treatment. Participants must be healthy, non-smokers, and able to follow the study's procedures. They cannot have had any facial surgery in the past year or acne scar treatments in the last six months, nor should they have certain health conditions like major depression, endocrine disorders, or a tendency to form keloid scars.

Inclusion Criteria

Subject must voluntarily sign and date an IRB approved informed consent form

Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period

I am willing and able to follow the treatment and check-up schedule.

Exclusion Criteria

I have not had acne scar treatments in the last 6 months.

I am unable to give consent for the study on my own.

I have not had chemotherapy in the last 12 months and do not have an immune deficiency.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 3 laser sessions with the Sciton Halo hybrid fractional laser. Sessions include before and after images, and completion of quality of life and satisfaction surveys.

3 months

3 visits (in-person)

Follow-up

Participants are monitored for changes in acne scar severity and quality of life.

5 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Sciton Halo
• Sciton Joule X Erbium Yag Fractional Ablative 2940nm laser

Trial Overview The Sciton Halo laser is being tested for its effectiveness on treating acne scars specifically in people with skin of color. The study will assess how well it works and how tolerable it is for participants.

How Is the Trial Designed?

Group I: Hybrid Fractional laser- Non- SOC Experimental Treatment 1 Intervention

23 participants with Fitzpatrick skin type I-III will be in this arm. At the first visit, participants will undergo informed consent, education about the procedure, education about proper sun-care, and will be provided sunscreen. Participants will be prescribed a prescription of hydroquinone or a retinol to prevent hyperpigmentation, per standard of care. If participants choose to take this they will wait one month of taking the prescription and then begin treatment sessions. If not, participants can begin treatment sessions right away. Treatment consists of 3 laser sessions with the Sciton Halo hybrid fractional laser. Session amount depends on the degree of improvement. At each session before and after images will be collected. At each session participants will fill out the dermatology quality of life survey as well as a patient satisfaction survey.

Group II: Hybrid Fractional laser - SOC Experimental Treatment 1 Intervention

23 participants with fitzpatrick skin type IV-V will be in this arm. At the first visit, participants will undergo informed consent, education about the procedure, education about proper sun-care, and will be provided sunscreen. Participants will be prescribed a prescription of hydroquinone or a retinol to prevent hyperpigmentation, per standard of care. If participants choose to take this they will wait one month of taking the prescription and then begin treatment sessions. If not, participants can begin treatment sessions right away. Treatment consists of 3 laser sessions with the Sciton Halo hybrid fractional laser. Session amount depends on the degree of improvement. At each session before and after images will be collected. At each session participants will fill out the dermatology quality of life survey as well as a patient satisfaction survey.

Sciton Halo is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Sciton Halo for:

• Acne scars
• Skin rejuvenation
• Fine lines
• Sun damage

Approved in European Union as Sciton Halo for:

• Acne scars
• Skin rejuvenation
• Fine lines
• Sun damage

Approved in Canada as Sciton Halo for:

• Acne scars
• Skin rejuvenation
• Fine lines
• Sun damage

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

Published Research Related to This Trial

Fractional picosecond laser (FPL) treatment for acne scars shows similar clinical improvement compared to conventional fractional lasers (FLs), based on a meta-analysis of seven studies.

FPL has a lower risk of post-inflammatory hyperpigmentation and pain, making it a better option for patients who are sensitive to these side effects, despite a higher incidence of temporary pinpoint bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional picosecond laser for atrophic acne scars: A meta-analysis. Li, J., Duan, F., Kuang, J.[2023]

In a study involving 75 patients, the combination of fractional erbium-YAG 2940 nm laser and platelet-rich plasma treatment showed significantly better improvement in acne scars compared to either treatment alone, with notable enhancements in scar grading and patient satisfaction.

All treatment modalities, including the combined approach, demonstrated only trivial side effects, indicating a favorable safety profile for these acne scar treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional Erbium-YAG Laser and Platelet-Rich Plasma as Single or Combined Treatment for Atrophic Acne Scars: A Randomized Clinical Trial. El-Taieb, MA., Ibrahim, HM., Hegazy, EM., et al.[2020]

In a study involving 40 patients, both the Er:Glass fractional laser and fractional radiofrequency microneedle device significantly improved atrophic acne scars, with scar severity scores improving by 25.0% and 18.6%, respectively, after three treatments.

While the Er:Glass fractional laser was found to be more effective overall, the fractional radiofrequency microneedle device provided good patient adherence and shorter recovery time, making it a viable alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study on efficacy and safety of 1550 nm Er:Glass fractional laser and fractional radiofrequency microneedle device for facial atrophic acne scar. Chae, WS., Seong, JY., Jung, HN., et al.[2022]

In a study of 58 Egyptian patients with moderate to severe acne atrophic scars, both fractional CO2 and fractional non-ablative 1540 nm erbium lasers were found to be effective treatments, with high patient satisfaction rates.

The fractional CO2 laser showed slightly higher efficacy in improving scar appearance, while the non-ablative erbium laser provided benefits of less pain and shorter recovery time, making both options viable for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ablative Fractional 10 600 nm Carbon Dioxide Laser Versus Non-ablative Fractional 1540 nm Erbium-Glass Laser in Egyptian Post-acne Scar patients. Elsaie, ML., Ibrahim, SM., Saudi, W.[2020]

In a study involving 24 subjects with mild-to-moderate acne scars, the fractional Er:YAG laser treatment showed a significantly greater improvement (50%) in acne scars compared to bipolar radiofrequency combined with diode laser (25%).

The superior efficacy of Er:YAG is linked to its ability to induce higher levels of collagen and specific cytokines involved in wound healing, suggesting that it promotes better skin regeneration compared to BRDL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between Er:YAG laser and bipolar radiofrequency combined with infrared diode laser for the treatment of acne scars: Differential expression of fibrogenetic biomolecules may be associated with differences in efficacy between ablative and non-ablative laser treatment. Min, S., Park, SY., Moon, J., et al.[2022]

The Er:YAG laser treatment for acne scars showed a significant average clinical improvement of 50.2% in 128 patients aged 22-42, indicating its efficacy in enhancing skin texture and reducing scarring.

The treatment was found to be safe, with most side effects being mild and temporary; however, some patients experienced prolonged erythema and post-inflammatory hyperpigmentation, which occurred in 7% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of atrophic facial acne scars with the Er:YAG laser: a Turkish experience. Kutlubay, Z., Gokdemir, G.[2022]

In a study involving 29 patients treated with the 1,550-nm fractional photothermolysis laser, 62% of participants experienced a 50% to 75% improvement in their acne scars, demonstrating the treatment's efficacy across various scar types and severities.

The treatment was found to be safe, with minimal side effects and no post-treatment pigmentary changes, making it suitable for patients with different skin types, including those with darker skin (Fitzpatrick Skin Types III to V).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-generation 1,550-nm fractional photothermolysis for the treatment of acne scars. Chrastil, B., Glaich, AS., Goldberg, LH., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05362929

Efficacy and Tolerability of a Hybrid Fractional Laser for the ... The investigators seek to investigate the Sciton Halo, hybrid fractional laser for its efficacy in treating acne scarring and tolerability in patients with a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9766513/

and Post- Hybrid Fractional Laser for the Treatment of Acne ... Blinded investigator scores of acne scars improved in the RSN cohort compared with the control. At day 30 post laser procedure 1, RSN had a mean ...

3. sciton.com sciton.com/blog-celebrating-10-years-of-innovation-with-the-worlds-first-hybrid-fractional-laser-halo/

Celebrating 10 Years of Innovation with the World's First ... HALO was the first laser of its kind to deliver exceptional results without the downtime associated with traditional ablative lasers.

4. trialx.com trialx.com/clinical-trials/listings/274504/efficacy-and-tolerability-of-a-hybrid-fractional-laser-for-the-treatment-of-acne-scars-in-patients-with-skin-of-color/?&geo_lat=41.0914&geo_lng=-73.9252&radius=10&place=Nyack&user_country=United%20States

Efficacy and Tolerability of a Hybrid Fractional Laser for the ... The investigators seek to investigate the Sciton Halo, hybrid fractional laser for its efficacy in treating acne scarring and tolerability ...

5. withpower.com withpower.com/trial/phase-acne-scars---mixed-atrophic-and-hypertrophic-4-2022-a3d08

Hybrid Fractional Laser for Acne Scars In a study involving 24 subjects with mild-to-moderate acne scars, the fractional Er:YAG laser treatment showed a significantly greater improvement (50%) in ...

6. drdarrenmckeown.com drdarrenmckeown.com/treatments/halo-laser-treatment/answerpack/halo-laser-treatment/what-are-the-risks-of-halo-laser-treatment/

What are the risks of HALO laser treatment? HALO laser treatment is generally safe, but like all procedures, it carries some risks. Potential side effects include temporary redness, swelling, or mild skin ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30481954/

Hybrid Fractional Laser: A Multi-Center Trial on the Safety ... RESULTS: Of the 29 subjects completing the study, 80% showed significant skin improvement on photographic analysis. Average numeric pain score ...