Clinical trial · Interventional
Maximizing Laser Therapy Success for Port-Wine Birthmarks in Pediatric Patients
NCT07183644CI-TRIAL-00113803recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Port Wine Stains | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cupping followed by Pulse Dye Laser (PDL) | Device | — | UNRESOLVED |
| IPL (Intense Pulsed Light) followed by Pulse Dye Laser (PDL) | Device | — | UNRESOLVED |
| Pulse Dye laser | Device | — | UNRESOLVED |
| Pulse Dye Laser (PDL) followed by Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet laser) laser. | Device | — | UNRESOLVED |
| Pulse Dye Laser (PDL) pulse width stacking | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- All patients
- description
- 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.
- interventionNames
- Device: Pulse Dye laser
- Device: Pulse Dye Laser (PDL) pulse width stacking
- Device: Pulse Dye Laser (PDL) followed by Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet laser) laser.
- Device: IPL (Intense Pulsed Light) followed by Pulse Dye Laser (PDL)
- Device: Cupping followed by Pulse Dye Laser (PDL)
Primary outcomes (2)
- measure
- Change in Port Wine Birthmark (PWB) color in participants - Pre Operative
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Months
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDChen JK, Ghasri P, Aguilar G, van Drooge AM, Wolkerstorfer A, Kelly KM, Heger M. An overview of clinical and experimental treatment modalities for port wine stains. J Am Acad Dermatol. 2012 Aug;67(2):289-304. doi: 10.1016/j.jaad.2011.11.938. Epub 2012 Feb 3. PMID 22305042
- BACKGROUNDJasim ZF, Handley JM. Treatment of pulsed dye laser-resistant port wine stain birthmarks. J Am Acad Dermatol. 2007 Oct;57(4):677-82. doi: 10.1016/j.jaad.2007.01.019. Epub 2007 Jul 19. PMID 17658196
- BACKGROUNDLee JW, Chung HY. Capillary Malformations (Portwine Stains) of the Head and Neck: Natural History, Investigations, Laser, and Surgical Management. Otolaryngol Clin North Am. 2018 Feb;51(1):197-211. doi: 10.1016/j.otc.2017.09.004. PMID 29217063
- BACKGROUNDAhcan U, Zorman P, Recek D, Ralca S, Majaron B. Port wine stain treatment with a dual-wavelength Nd:Yag laser and cryogen spray cooling: a pilot study. Lasers Surg Med. 2004;34(2):164-7. doi: 10.1002/lsm.10252. PMID 15004829
- BACKGROUNDLi G, Lin T, Wu Q, Zhou Z, Gold MH. Clinical analysis of port wine stains treated by intense pulsed light. J Cosmet Laser Ther. 2010 Feb;12(1):2-6. doi: 10.3109/14764170903449778. PMID 20085450