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

Not Applicable

Recruiting

• Conditions: Port-Wine Stains (Capillary Malformations)

• Registration Number: NCT07015073
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.

Study Timeline

• Study Start: 2024-12-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in lesion appearance measured by Investigator Global Assessment (IGA)	6 weeks after treatment	The IGA is a 5-point scale ranging from 0 (no changes) to 4 (complete or near-complete clearance). It will be assessed by three blinded dermatologists comparing standardized clinical photographs of each treated area. The outcome will be reported as the mean IGA score per treatment modality.

Secondary Outcome Measures

Name	Time	Method
Pain score during laser treatment (VAS)	Immediately after the procedure	Participants will rate their pain during each treatment using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (maximum imaginable pain).
Local events at 48 hours	48 hours after treatment	Presence of local side effects such as edema, purpura, and crusting will be documented clinically by the investigators.
Patient satisfaction score	6 weeks after treatment	Patients will rate their satisfaction with each treated area on a scale from 0 (not satisfied at all) to 6 (very satisfied).

Trial Locations

Locations (1)

Ramon y Cajal University Hospital; 🇪🇸 Madrid, Spain