Maximizing Laser Therapy Success for Port-Wine Birthmarks in Pediatric Patients

Not Applicable

Not yet recruiting

• Conditions: Port Wine Stains

• Registration Number: NCT07183644
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-07
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Primary Completion: 2028-09
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Diagnosis of Port Wine Stain.
• Age Range: 2mo to 18 years of age.
• Stable PWS: The port wine stain should be stable, meaning there is no active inflammation or infection present, and it should not be changing in size or color due to factors like injury or disease.
• signed Consent: For ethical reasons, participants must be able to provide informed consent. In the case of minors, consent would generally be required from a parent or legal guardian.

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

• severe allergies to anesthesia
• active skin infections or inflammation
• recent laser therapy
• use of Photosensitizing medications
• participation in other laser studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Port Wine Birthmark (PWB) color in participants - Pre Operative	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.
Change in Port Wine Birthmark (PWB) color in participants - Post Operative	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.

Trial Locations

Locations (1)

Children's Medical Center; 🇺🇸 Plano, Texas, United States