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RecruitingNot ApplicableNCT07015073

Comparative of Sequential Application of Pulsed Dye Laser and Potassium-titanyl-phosphate Laser Treatment for Capillary Malformations Versus Single Application

Comparative Efficacy and Tolerability of Pulsed Dye Laser and Potassium-titanyl-phosphate Laser Treatment for Capillary Malformations: Sequential Versus Single Application

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Enrollment

30 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Port-Wine Stains (Capillary Malformations)

Summary

This prospective, non-randomized study aims to evaluate the efficacy and tolerability of treating port-wine stains (capillary malformations) using pulsed dye laser (PDL), potassium titanyl phosphate (KTP) laser, or a sequential combination of both. Each participant will receive all three treatments on different areas of the lesion. The primary outcome is improvement measured using the Investigator Global Assessment (IGA) scale. Secondary outcomes include pain (VAS), local adverse events, and patient satisfaction.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Age ≥18
  • Fitzpatrick skin types I-IV
  • Presence of port-wine stain

Exclusion Criteria4

  • Open wounds in treatment area
  • Pregnancy
  • Nearby metal implants
  • Photodermatoses

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Interventions

DEVICEPulsed dye laser (PDL)

Treatment with a pulsed dye laser (PDL) at 595 nm using the VBeam Prima® system (Candela Medical). Parameters: 10 mm spot size, 7-9 J/cm² fluence, 0.5-3 ms pulse duration. Cryogen spray cooling is applied. No anesthesia is used. This intervention will be applied to one of the three defined regions of each participant's port-wine stain.

DEVICEPotassium titanyl phosphate (KTP) laser

Treatment with a KTP laser at 532 nm using the DermaV® system (Lutronic Medical Systems). Parameters: 10 mm spot size, 8-11 J/cm² fluence, 10 ms pulse duration. Cryogen spray cooling is applied. No anesthesia is used. This intervention will be applied to a second anatomically comparable region of the port-wine stain.

DEVICESequential KTP + PDL laser treatment

Sequential treatment of the same region with two lasers: first with KTP (532 nm, DermaV® system), then with PDL (595 nm, VBeam Prima® system). Each laser will be applied using its standard parameters: KTP (10 mm spot, 8-11 J/cm², 10 ms), followed by PDL (10 mm spot, 7-9 J/cm², 0.5-3 ms). Cryogen spray cooling is used before each pass. No anesthesia is applied. This treatment is administered to a third region of the port-wine stain.

Locations(1)

Ramon y Cajal University Hospital

Madrid, Spain, Spain

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NCT07015073