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

Official title

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

Overview

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.

Detailed description

Port-wine stains (PWS), also known as capillary malformations, are congenital vascular anomalies affecting approximately 0.3-0.5% of newborns. These lesions, often located on the face and neck, tend to darken and thicken over time, potentially leading to psychosocial distress and reduced quality of life. Pulsed dye laser (PDL) therapy has long been the standard of care, utilizing selective photothermolysis to target dilated capillaries. Despite its safety and effectiveness, complete clearance is achieved in only 10-20% of cases.

Recently, long-pulsed potassium titanyl phosphate (KTP) lasers operating at 532 nm have emerged as viable options for vascular lesions, offering greater spot sizes, variable pulse durations, and integrated cryogen cooling systems that allow deeper and more consistent energy delivery. Clinical experience suggests that combining PDL and KTP treatments sequentially may enhance treatment outcomes, especially in resistant PWS, yet no controlled study has directly compared this approach to either treatment in isolation.

This prospective, single-center, non-randomized clinical trial aims to compare the efficacy, safety, and patient satisfaction of PDL (595 nm), KTP (532 nm), and sequential KTP followed by PDL in adults with PWS. Each lesion will be divided into three anatomically comparable areas, each receiving a different treatment modality. All treatments will be administered with cryogen spray cooling and without anesthesia, according to current clinical practice.

The primary endpoint is improvement at 6 weeks based on the Investigator Global Assessment (IGA) scale, evaluated by three blinded dermatologists. Secondary outcomes include pain during treatment (VAS), adverse events at 48 hours, and patient satisfaction scores. A total of 30 patients will be enrolled to ensure adequate statistical power and account for potential dropouts.

This study seeks to provide evidence supporting the optimal laser treatment strategy for PWS, potentially improving clinical outcomes and guiding future protocols.

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.

Primary outcome measures

• Change in lesion appearance measured by Investigator Global Assessment (IGA) [Time frame: 6 weeks after treatment]

Secondary outcome measures (3)

• Pain score during laser treatment (VAS) [Time frame: Immediately after the procedure]
• Local events at 48 hours [Time frame: 48 hours after treatment]
• Patient satisfaction score [Time frame: 6 weeks after treatment]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Ramon y Cajal University Hospital — Madrid

Identifiers

NCT: NCT07015073 · 232/24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗