Comparing pulsed dye, KTP, and sequential KTP→PDL laser treatment for port‑wine stains
Comparative Efficacy and Tolerability of Pulsed Dye Laser and Potassium-titanyl-phosphate Laser Treatment for Capillary Malformations: Sequential Versus Single Application
NA · Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · NCT07015073
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (other) |
| Locations | 1 site (Madrid, Spain) |
| Trial ID | NCT07015073 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Madrid, Spain
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Port-Wine Stains, port-wine stains, capillar malformation, laser, pulsed dye laser, KTP laser