Laser Treatment for Scars and Scleroderma

Overseen By Lais 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a laser treatment to determine its effects on collagen, a protein that gives skin its structure, in individuals with hypertrophic scars and scleroderma. Researchers aim to discover if the laser can alter or regenerate collagen, improving the skin's appearance and condition. The trial includes two groups: one with hypertrophic scars and the other with scleroderma, both receiving laser treatment. Ideal participants have noticeable scars or scleroderma patches that haven't recently undergone certain medications or procedures. As an unphased trial, this study provides a unique opportunity to contribute to pioneering research that could lead to new treatments for skin conditions.

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 prior data suggests that this laser treatment is safe for scars and scleroderma?

Research has shown that laser treatment could help with both scleroderma and thick scars. For scleroderma, studies have found that laser therapy can improve the skin's appearance and function. The 1064 nm Nd:YAG laser has been used successfully, particularly in severe cases with fingertip sores.

For thick scars, laser treatments have been well-researched as well. They can make scars thinner and improve their color and appearance. The pulsed dye laser is particularly noted for its safety and effectiveness, with few participants dropping out of studies.

While laser treatments can be effective, they may have side effects and can be expensive. Prospective trial participants should consider these factors and consult their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for scars and scleroderma, which often involve topical creams, surgery, or medication to manage symptoms, laser treatment directly targets the affected skin areas. This non-invasive approach uses concentrated light to break down scar tissue and stimulate the production of new, healthy skin. Researchers are excited because laser treatment offers precision in targeting lesions and has the potential for quicker recovery and skin improvement compared to conventional methods. Plus, it can significantly reduce symptoms without the need for more aggressive interventions.

What evidence suggests that this laser treatment is effective for scars and scleroderma?

Research has shown that laser treatment can help with both scleroderma and thick scars. In this trial, participants will be divided into two groups: one will receive laser treatment for scleroderma, and the other for thick scars. For scleroderma, studies have found that CO2 laser therapy can improve skin appearance and function, and even assist with mouth opening in severe cases. Another study reported enhanced skin flexibility and movement after laser treatments. For thick scars, fractional laser therapy has greatly improved scar appearance by making them thinner and more flexible. Many patients with thick scars experienced significant improvement in their scar ratings after laser treatment. These findings suggest that laser therapy could be promising for improving skin conditions in both scleroderma and scars. ^{6 7 8 9 10}

Who Is on the Research Team?

Dieter Manstein, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Laser Treatment

Trial Overview

The 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.

How Is the Trial Designed?

Group I: Scleroderma Active Control 1 Intervention

The entire lesion will receive laser treatment.

Group II: Scars Active Control 1 Intervention

The entire hypertrophic scar will receive laser treatment only.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6906753/

A Review of Laser Remodeling of Hypertrophic Scars and Burns

Among 15 patients with hypertrophic and keloidal scars, only the HTS showed significant improvement after three CO2 fractional laser sessions. However, one ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9366502/

Hypertrophic Scar Outcomes in Fractional Laser ...

In conclusion, fractional laser monotherapy is an effective treatment for hypertrophic scars, and the application of topical corticosteroid provides no long ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0305417924001360

Impact of laser treatment on hypertrophic burn scars in ...

Most body regions showed improvement in modified Vancouver Scar Scale (mVSS) score with laser treatment. mVSS scores improved significantly with treatment to ...

4.

nature.com

nature.com/articles/s41598-020-78738-9

Treatment of hypertrophic scars and keloids using an ...

Results showed that the laser therapy can significantly reduce the blood supply, decrease thickness and enhance pliability of HSK. In particular ...

5.

academic.oup.com

academic.oup.com/jbcr/advance-article/doi/10.1093/jbcr/iraf167/8253493

Laser-Assisted Drug Delivery for Hypertrophic Scar Treatment

The clinical outcomes achieved with LADD are unclear, largely due to the variability of study methodology and outcome measurement. The efficacy of this ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7175764/

Laser management of hypertrophic burn scars - PubMed Central

As laser technology developed, studies have shown decreased scar thickness, neuropathic pain, and need for surgical excision, as well as improved scar color, ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9511989/

Laser therapy for treating hypertrophic and keloid scars - PMC

Laser therapy is expensive and has potentially harmful side effects, so it is important to establish whether it is safe and effective. What is the aim of this ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0305417925001299

Early Laser for Burn Scars (ELABS)

Pulsed dye laser treatment is safe and effective for hypertrophic burn scarring. •. This study had a low attrition rate of 9.8 %. •. Pulsed dye laser should ...

9.

nature.com

nature.com/articles/s41598-024-78094-y

Efficacy and safety of sequential treatment with botulinum ...

Our study suggests that including BTX-A treatment before fractional CO2 laser and topical growth factors offers superior efficacy in reducing hypertrophic ...

10.

medicaljournalssweden.se

medicaljournalssweden.se/actadv/article/view/967/1265

View of Hypertrophic Scar Outcomes in Fractional Laser ...

In this randomized, comparative, split-scar trial of 19 subjects, a borderline significant reduction in scar thickness was observed at 3-month follow-up in the ...