Clinical trial NCT07015073: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Port-Wine Stains (Capillary Malformations)
Keywords: port-wine stains
capillar malformation
laser
pulsed dye laser
KTP laser
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment (within-subject comparison of three treatment modalities on different lesion areas)
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Change in lesion appearance measured by Investigator Global Assessment (IGA)
timeFrame: 6 weeks after treatment
Secondary outcomes:
measure: Pain score during laser treatment (VAS)
timeFrame: Immediately after the procedure
measure: Local events at 48 hours
timeFrame: 48 hours after treatment
measure: Patient satisfaction score
timeFrame: 6 weeks after treatment
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ramon y Cajal University Hospital
Study officials:
References: