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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Pulsed Dye Laser (PDL)Active comparator 1 intervention
Group B: Potassium Titanyl Phosphate Laser (KTP)Active comparator 1 intervention
Group C: Sequential KTP + PDLExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
6 weeks after treatment

Secondary outcomes

1

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).

Time frame
Immediately after the procedure
2

Local events at 48 hours

Presence of local side effects such as edema, purpura, and crusting will be documented clinically by the investigators.

Time frame
48 hours after treatment
3

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).

Time frame
6 weeks after treatment

Other outcomes

Sponsors and contacts

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