Laser Therapy for Port-Wine Stain

Not yet recruiting at 1 trial location

Overseen By James R Seaward, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Photosensitizing medications

Disqualifiers: Severe allergies, Active infections, Recent laser, others

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

Compensation: Varies

Number of Visits: 2

Duration: 5-7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance laser therapy for children with Port-Wine Stain (a type of birthmark) by testing various treatment methods to determine the most effective one. The goal is to reduce the number of treatments needed and minimize the use of general anesthesia. Participants will try several treatment combinations, including Cupping followed by Pulse Dye Laser (PDL), Intense Pulsed Light (IPL) followed by Pulse Dye Laser (PDL), Pulse Dye Laser alone, and Pulse Dye Laser (PDL) followed by Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet laser). The most effective treatment will continue until the birthmark fades. This trial suits children with stable Port-Wine Stain who do not have skin infections or severe allergies to anesthesia. As an unphased trial, it allows participants to explore innovative treatment combinations that could lead to fewer procedures and less anesthesia.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using photosensitizing medications (drugs that make your skin more sensitive to light).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments in this trial are generally safe. The Pulse Dye Laser (PDL), used in all treatment groups, has a strong safety record. Studies have found it carries a low risk of serious problems, and side effects are usually mild. For instance, a review of 974 children treated with PDL for port-wine stains over 20 years demonstrated its safety with few complications.

Similarly, combining Intense Pulsed Light (IPL) with PDL is safe. A study comparing IPL and PDL found both treatments effective in lightening port-wine stains, with no reported adverse events.

When PDL is combined with the Nd:YAG laser, research shows the Nd:YAG laser is effective with few complications. It has been used successfully for blood vessel issues, demonstrating a safe profile.

Lastly, using multiple pulses with PDL, known as pulse width stacking, is also safe. Studies confirm its safety with minimal side effects.

Overall, these treatments are well-tolerated, with research supporting their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for port-wine stains because they explore various laser combinations and techniques that could enhance efficacy compared to current options. Unlike standard treatments that often rely solely on a single laser type, this approach investigates the use of multiple laser types and techniques such as pulse width stacking, which could lead to better clearance of port-wine stains. By testing combinations like Pulse Dye Laser followed by Nd:YAG and comparing them against traditional methods, there's potential for more personalized and effective treatment strategies. This trial could uncover which specific laser method or combination offers the best results, paving the way for optimized care in treating port-wine stains.

What evidence suggests that this trial's treatments could be effective for Port-Wine Stain?

Research has shown that the Pulse Dye Laser (PDL) effectively treats port-wine stains, with 61.56% of patients achieving good or excellent results after several sessions. In this trial, all patients will initially receive multiple treatment modalities: PDL alone, PDL followed by Nd:YAG, and PDL combined with IPL (Intense Pulsed Light). If PDL alone proves insufficient, adding Nd:YAG may enhance results, as it has successfully treated similar skin conditions. While PDL alone can lead to significant improvements, combining it with other methods like IPL has produced mixed results. Although IPL alone is less effective than PDL, some patients experience good outcomes when both are used together. Using a technique called pulse width stacking with PDL may further improve results, especially for more challenging cases. ^{2 4 6 7 8}

Who Is on the Research Team?

James Seaward, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for children aged 2 months to 18 years with a stable Port-Wine Stain birthmark. They must be in good health and not have skin conditions, infections, or hypersensitivity to light that could interfere with laser therapy. Consent from a parent or guardian is required for minors.

Inclusion Criteria

Participants must be able to provide informed consent. In the case of minors, consent would generally be required from a parent or legal guardian

Participants should generally be in good health, with no contraindications for laser therapy, such as certain skin conditions, infections, or hypersensitivity to light

My port wine stain is not inflamed, infected, or changing in size or color.

Exclusion Criteria

Severe allergies to anesthesia

Participation in other laser studies

I currently have an active skin infection or inflammation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo up to two laser treatment sessions with five treatment modalities applied to optimize Port-Wine Birthmark (PWB) laser therapy.

5-7 weeks

1 visit (in-person)

Follow-up

Participants are monitored for treatment effectiveness and PWB clearance, with follow-up visits every 5-7 weeks.

5-7 weeks

1 visit (in-person)

Extension

Continued treatment with the best modality until PWB is no longer visible or treatment is no longer effective.

What Are the Treatments Tested in This Trial?

Interventions

• Cupping followed by Pulse Dye Laser (PDL)
• IPL (Intense Pulsed Light) followed by Pulse Dye Laser (PDL)
• Pulse Dye laser
• Pulse Dye Laser (PDL) followed by Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet laser)
• Pulse Dye Laser (PDL) pulse width stacking

Trial Overview The study tests different combinations of laser treatments on Port-Wine Stains: Cupping then PDL, PDL pulse width stacking, IPL followed by PDL, standalone PDL, and PDL followed by Nd:YAG laser. The goal is fewer treatments and better results.

How Is the Trial Designed?

Group I: All patients Active Control 5 Interventions

Every patient will receive the 5 treatment modalities in their first laser treatment after enrollment in the study. * At 5-7 weeks follow-up visit after the procedure, if no treatment modality is better than the other, then the surgeon will repeat the procedure with the 5 modalities, and the subject will have a 2nd follow-up appointment 5-7 weeks later. Continue treatment with 5 modalities and appropriate follow-up until Port Wine Birthmark (PWB) clearance, or, * If any modality is seen to give best results at the first follow-up visit (5-7 weeks after the first procedure), then the next treatment will be only with that modality and will continue to have treatments with this modality and follow-up appointments (5-7 weeks after procedure) according to standard of care timelines for PWBs until the treatment is not improving the PWB anymore or until the PWB is no longer visible.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11887490/

Efficacy and Safety Evaluation of 595 nm Pulsed Dye Laser ... Multiple treatments significantly improved efficacy, with 61.56% of patients achieving good or excellent responses after more than six sessions.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6618082/

Port wine stain treatment outcomes have not improved over ... Although a few studies reported remarkably good outcomes in a subset of carefully selected patients, there was no upward trend over time in mean clearance.

3. dovepress.com dovepress.com/pulsed-dye-laser-for-port-wine-stains-in-974-children-a-20-year-study--peer-reviewed-fulltext-article-CCID

Pulsed Dye Laser for Port Wine Stains in 974 Children This study aims to evaluate the efficacy and adverse effects of PDL treatment in children by reviewing 974 PWS cases over nearly 20 years.

4. birthmark.org birthmark.org/wp-content/uploads/2024/04/FILE_9705.pdf

Weekly Pulsed Dye Laser Treatments for Port-Wine ... INTERVENTION Once-weekly PDL treatments. MAIN OUTCOMES AND MEASURES The primary outcome was the percentage improvement of. PWB, which was graded ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11828787/

Efficacy and prognostic factors for successful treatment of port ... Yellow laser is a successful therapy choice for PWS, with a statistically significant improvement and minimal adverse effects.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38141129/

Complication rates and safety of pulsed dye laser treatment ... Overall, PDL treatment for PWS shows a high level of safety and low chances of causing long-term complications.

7. birthmark.org birthmark.org/wp-content/uploads/2019/03/JAMAdermatology_PulseDyeLaser-for-PWS.pdf

Pulsed Dye Laser Treatment of Port-Wine Stains in Infancy ... Question Is it safe and effective to initiate port-wine stain laser treatments without general anesthesia in infancy? Findings In this ...

8. jwatch.org jwatch.org/jd201302150000001/2013/02/15/optimal-treatment-intervals-with-pulsed-dye

Optimal Treatment Intervals with the Pulsed-Dye Laser for ... PDL is safe, even when used in very young patients and with short treatment intervals. Port-wine stains (PWSs) affect 0.3% to 0.5% of newborns, ...