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

NCT07015073 | Recruiting FDA Device

• 1 other identifier: 232/24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Port-Wine Stains (Capillary Malformations)

Keywords

port-wine stains; capillar malformation; laser; pulsed dye laser; KTP laser

Outcome Measures

Primary Outcomes (1)

• Change in lesion appearance measured by Investigator Global Assessment (IGA)

  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.

  6 weeks after treatment

Secondary Outcomes (3)

• Pain score during laser treatment (VAS)

  Immediately after the procedure

• Local events at 48 hours

  48 hours after treatment

• Patient satisfaction score

  6 weeks after treatment

Study Arms (3)

Pulsed Dye Laser (PDL)

ACTIVE COMPARATOR

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.

Device: Pulsed dye laser (PDL)

Potassium Titanyl Phosphate Laser (KTP)

ACTIVE COMPARATOR

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.

Device: Potassium titanyl phosphate (KTP) laser

Sequential KTP + PDL

EXPERIMENTAL

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.

Device: Sequential KTP + PDL laser treatment

Interventions

Pulsed dye laser (PDL) DEVICE

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.

Pulsed Dye Laser (PDL)

Potassium titanyl phosphate (KTP) laser DEVICE

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.

Potassium Titanyl Phosphate Laser (KTP)

Sequential KTP + PDL laser treatment DEVICE

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.

Sequential KTP + PDL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Fitzpatrick skin types I-IV
• Presence of port-wine stain

You may not qualify if:

• Open wounds in treatment area
• Pregnancy
• Nearby metal implants
• Photodermatoses

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Ramon y Cajal University Hospital

Madrid, Spain, 28034, Spain

RECRUITING

MeSH Terms

Conditions

Port-Wine Stain; Capillary Malformations, Congenital, 1

Interventions

Lasers, Dye; Lasers

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Jorge Naharro-Rodriguez, M.D.

CONTACT

+34 91 336 80 00; jorgenrmed@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: Crossover Assignment (within-subject comparison of three treatment modalities on different lesion areas)

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: December 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)