Comparing pulsed dye, KTP, and sequential KTP→PDL laser treatment for port‑wine stains
Official title: Comparative Efficacy and Tolerability of Pulsed Dye Laser and Potassium-titanyl-phosphate Laser Treatment for Capillary Malformations: Sequential Versus Single Application
Run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · NCT07015073 · Data updated 2026-11-12
This study will try pulsed dye laser, KTP laser, and a sequential KTP then PDL approach on different parts of your port‑wine stain to see which lightens the lesion best and is most tolerable.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Academic / other |
| Locations | 1 site (Madrid, Spain) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | July 2025 |
| Study ends | August 2025 |
| Registry record updated | June 11, 2025 |
| Trial ID | NCT07015073 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with a port‑wine stain and Fitzpatrick skin types I–IV who can attend in‑person visits at Ramon y Cajal University Hospital are potential candidates.
✕Probably not a fit
Patients who are pregnant, have open wounds at the treatment site, nearby metal implants, photodermatoses, or Fitzpatrick skin types V–VI are not eligible and therefore will not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, non-randomized trial divides each participant's port‑wine stain into three comparable areas, treating one area with pulsed dye laser (595 nm), one with long‑pulse KTP laser (532 nm), and one with sequential KTP followed by PDL. Treatments are given without anesthesia using cryogen spray cooling, and each participant receives all three modalities on their lesion. The primary outcome is improvement on the Investigator Global Assessment (IGA) scale, with secondary outcomes including pain (VAS), local adverse events, and patient satisfaction. The trial enrolls adults with Fitzpatrick skin types I–IV and excludes those with open wounds, pregnancy, nearby metal implants, or photodermatoses.
Why it matters
Potential benefit: If successful, the sequential or alternate laser approach could produce better lightening of port‑wine stains and improved patient satisfaction compared with either laser alone.
How similar studies have gone: Pulsed dye laser is the long‑standing standard of care and KTP lasers have shown promising results, but direct controlled comparisons of sequential KTP+PDL versus single modalities are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 * Fitzpatrick skin types I-IV * Presence of port-wine stain Exclusion Criteria: * Open wounds in treatment area * Pregnancy * Nearby metal implants * Photodermatoses
Where it's running
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Ramon y Cajal University Hospital
Madrid, Spain, Spain Recruiting
Study contacts
- Study coordinator: Jorge Naharro-Rodriguez, M.D.
- Email: jorgenrmed@gmail.com
- Phone: +34 91 336 80 00
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Maximizing laser therapy success for Port-Wine Birthmarks in kids
This study tests different laser treatment sequences to see which approach clears Port-Wine Stains in children with fewer sessions and less need for anesthesia.
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ADVATx laser treatment for port-wine stains (vascular birthmarks)
This project will test whether four monthly ADVATx laser treatments can lighten port-wine stains in people with lesions at least 15 cm² and Fitzpatrick skin types I–IV.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.