About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18
Fitzpatrick skin types I-IV
Presence of port-wine stain
Disqualifiers
Open wounds in treatment area
Pregnancy
Nearby metal implants
Photodermatoses
Trial design
Crossover
Treatments tested in this trial
Pulsed dye laser (PDL)
DeviceTreatment 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.
Potassium titanyl phosphate (KTP) laser
DeviceTreatment 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.
Sequential KTP + PDL laser treatment
DeviceSequential 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Pain score during laser treatment (VAS)
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
Presence of local side effects such as edema, purpura, and crusting will be documented clinically by the investigators.
Patient satisfaction score
Patients will rate their satisfaction with each treated area on a scale from 0 (not satisfied at all) to 6 (very satisfied).
Sponsors and contacts
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