Apply to Trial

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate

20 Participants Needed

Laser Treatment for Scars and Scleroderma

Overseen ByLais Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Anti-inflammatories, Immunosuppressives

Disqualifiers: Pregnancy, Lactation, Allergies, others

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

Trial Summary

What is the purpose of this trial?

In this study, the investigators seek to evaluate the effects of a laser treatment on the redistribution/regeneration of collagen on the clinical, microscopic, and molecular profiles of hypertrophic scars and scleroderma.

Will I have to stop taking my current medications?

The trial requires that you have not used any prescription or in-clinic medications on the eligible scars or scleroderma in the past 3 months, and you should not be taking high doses of anti-inflammatory or immunosuppressive drugs regularly. If you are on these medications, you may need to stop them before participating.

What data supports the effectiveness of the treatment Laser Treatment for scars and scleroderma?

Research shows that laser treatment is effective for improving the appearance of various types of scars, such as burn scars and surgical scars, by reducing thickness, improving texture, and preventing excessive scar growth. This suggests that laser treatment could also be beneficial for managing scars in scleroderma.¹ ² ³ ⁴ ⁵

Is laser treatment generally safe for humans?

Laser treatments, including those for skin resurfacing and scar improvement, are generally considered safe with a low risk of complications. Most side effects are mild and temporary, such as redness and swelling, but more serious issues like scarring are rare. Safety data from various studies suggest that while complications can occur, they are not common and can often be managed effectively.⁶ ⁷ ⁸ ⁹ ¹⁰

How is laser treatment unique for scars and scleroderma?

Laser treatment is unique because it can specifically target and improve the appearance of different types of scars, such as burn scars, by reducing thickness and improving texture. It is more effective than topical treatments and can be used alongside surgery to enhance mobility and reduce scar-related issues.¹ ⁵ ¹¹ ¹² ¹³

Research Team

Dieter Manstein, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adults over 18, willing to consent and follow study rules, in good health based on screening, who can read English. They must have a large hypertrophic scar or scleroderma lesions suitable for treatment. Pregnant individuals, recent trial participants, those using certain medications/treatments for scars/scleroderma, with allergies to anesthetics or taking high doses of anti-inflammatory/immunosuppressive drugs cannot join.

Inclusion Criteria

I have a large scar or two similar scars suitable for treatment.

Subject must be able to read and understand English

My gender and skin type do not limit my participation.

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Exclusion Criteria

I regularly take high doses of anti-inflammatory or immunosuppressive drugs.

I haven't used prescription meds or treatments on my scars/scleroderma in the last 3 months.

Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive laser treatment on the entire lesion for hypertrophic scars and scleroderma

Immediate

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

Treatment Details

Interventions

Laser Treatment

Trial OverviewThe study is testing how effective laser treatment is at improving the appearance and condition of hypertrophic scars and scleroderma by promoting collagen redistribution/regeneration. It will look at clinical outcomes as well as microscopic and molecular changes.

Participant Groups

2Treatment groups

Active Control

Group I: SclerodermaActive Control1 Intervention

The entire lesion will receive laser treatment.

Group II: ScarsActive Control1 Intervention

The entire hypertrophic scar will receive laser treatment only.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

Laser therapy, particularly fractional lasers, plays a crucial role in scar treatment by normalizing both the appearance and structure of scars, enhancing the overall effectiveness of scar rehabilitation.

Combining laser treatments with other methods like surgery and physical therapy leads to significant improvements in scar management while minimizing patient discomfort and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current trends and future considerations in scar treatment.Waibel, JS., Rudnick, A.[2019]

Aesthetic laser surgery carries risks, and it is crucial for surgeons to understand potential adverse effects to minimize complications during procedures.

Patients should receive thorough education about the risks and expectations of laser surgery to ensure they can recognize and address any complications that may arise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of aesthetic laser surgery.Aghassi, D., Carpo, B., Eng, K., et al.[2019]

Cutaneous lasers and energy modalities like radiofrequency and ultrasound are generally safe, with rapid healing times and mild, self-resolving side effects such as redness and swelling lasting only hours to days.

While most adverse events are mild, there are some medium- to long-term risks, including changes in skin pigmentation and scarring, but these are rare and can often be managed effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of lasers and light treatments.Alam, M., Warycha, M.[2022]