Comparative Efficacy and Tolerability of Pulsed Dye Laser and Potassium-titanyl-phosphate Laser Treatment for Capillary Malformations: Sequential Versus Single Application
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18
• Fitzpatrick skin types I-IV
• Presence of port-wine stain
Locations
Other Locations
Spain
Ramon y Cajal University Hospital
RECRUITING
Madrid
Contact Information
Primary
Jorge Naharro-Rodriguez, M.D.
jorgenrmed@gmail.com
+34 91 336 80 00
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2025-08
Participants
Target number of participants: 30
Treatments
Active_comparator: Pulsed Dye Laser (PDL)
Participants will receive pulsed dye laser treatment (595 nm) on one defined area of their port-wine stain. The treatment will be administered using the VBeam Prima® system (Candela Medical) with standard clinical parameters: 10 mm spot size, 7-9 J/cm² fluence, and 0.5-3 ms pulse duration. Cryogen spray cooling will be used, and no anesthesia will be applied.
Active_comparator: Potassium Titanyl Phosphate Laser (KTP)
Participants will receive potassium titanyl phosphate laser treatment (532 nm) on another defined area of the same lesion. Treatment will be performed using the DermaV® system (Lutronic Medical Systems) with standard parameters: 10 mm spot size, 8-11 J/cm² fluence, and 10 ms pulse duration. Cryogen spray cooling will be used; no anesthesia will be applied.
Experimental: Sequential KTP + PDL
Participants will receive sequential treatment on a third, anatomically matched area of their port-wine stain. The area will first be treated with the KTP laser (532 nm; DermaV® system), followed immediately by pulsed dye laser (595 nm; VBeam Prima®). Parameters for each device will match those used in the monotherapy arms. Cryogen spray cooling will be applied before each pass, without anesthesia.
Related Therapeutic Areas
Sponsors
Leads: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal