NCT Number: NCT07183644
In this study the investigators aim to optimize Port-Wine-Birthmark (PBW) laser therapy in children in order to reduce the number of laser treatments required for clearance and improve outcomes for refractory cases. This approach also seeks to reduce the frequency with which children require general anesthesia for treatment.
Interested in participating?
Request Info2 month–18 year
All sexes
Interventional
Not applicable
Children's Medical Center, Dallas, Texas, United States
Participants will undergo up to two laser treatment sessions on the Port-Wine Birthmark (PWB), in which five treatment modalities will be applied. The modality with the best outcomes will be used for subsequent treatments until the PWB is cleared or treatment with that modality reaches an outcome plateau, as determined by the treating physician. If no further outcome response is observed with that modality, the patient will undergo a second round of the five different modalities to determine if there are differences in efficacy. The treatment modality showing the best response will then be continued. Patient outcomes will then be analyzed to determine if there are significant differences between treatment modalities as well as among primary treatment patients and refractory cases.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
General Health: Participants should generally be in good health, with no contraindications for laser therapy, such as certain skin conditions, infections, or hypersensitivity to light.
Exclusion criteria
Pulse Dye Laser (PDL) standard settings. This is the same procedure children would receive as standard of care if these individuals were not participating in this study.
The surgeon will perform 1 pass with the PDL over the area of the Port wine birthmark (PWB).
This procedure is used for some patients as standard of care depending on the severity and depth of the lesion.
The surgeon will perform 3 passes with the PDL over the PWB, gradually increasing the pulse duration with each pass to effectively target both superficial and deeper blood vessels.
The combination of these two lasers is one of the investigational treatments. The surgeon will perform 1 pass per laser over the PWB. The 1st pass will be with the PDL to target the blood vessels closer to the top of the skin, followed by a 2nd pass with the Nd:YAG laser to target the blood vessels that deeper in the skin.
The surgeon will perform 1 pass with the IPL followed by 1 pass with the PDL over the PWB
The combination of these modalities is one of the experimental procedures. The surgeon will place a small suction cup over the PWB target region of the PDL for a few seconds to stop the blood flow and accumulate the blood in that spot. The PDL treatment will then quickly proceed. Since the PDL targets red blood cells, it will allow the laser to target the pooled blood in the abnormal blood vessels better.
Time frame: Baseline
Prior to treatment, the PWB will be documented photographically. Images taken will be transformed in to the L a*b* colorspace (also known as the red green color axis), and regions of interest defined on the photographs corresponding with the areas treated by each modality, as well as a region of interest adjacent to the treated area, to act as a control to correct for skin changes unrelated to the treatment. The axis is representative of color chromaticity and is measured in a range of -128 to 127. Positive values are indicative of red, and negative values are indicative of green.
The quantitative values of the a* channel in the L a*b* colorspace will be used as a measure of the PWB intensity and each treated area will be compared with the corresponding area pre-treatment, using the difference in a* values to determine the treatment effectiveness.
Time frame: 6 weeks
Post-operatively, the treated area will once more be documented photographically.
Images taken will be transformed in to the L a*b* colorspace (also known as the red green color axis), and regions of interest defined on the photographs corresponding with the areas treated by each modality, as well as a region of interest adjacent to the treated area, to act as a control to correct for skin changes unrelated to the treatment. The axis is representative of color chromaticity and is measured in a range of -128 to 127. Positive values are indicative of red, and negative values are indicative of green.
The quantitative values of the a* channel in the L a*b* colorspace will be used as a measure of the PWB intensity and each treated area will be compared with the corresponding area pre-treatment, using the difference in a* values to determine the treatment effectiveness.
Contact information is provided by the study sponsor or research team.
James R Seaward, MD
CONTACT
Lauren Bailey, MS
CONTACT
University of Texas Southwestern Medical Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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