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

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

July 31, 2025

Study Completion Date

August 31, 2025

Conditions
Port-Wine Stains (Capillary Malformations)
Interventions
DEVICE

Pulsed 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.

DEVICE

Potassium 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.

DEVICE

Sequential 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.

Trial Locations (1)

28034

RECRUITING

Ramon y Cajal University Hospital, Madrid

All Listed Sponsors
lead

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER