[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594102":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":36,"studyPopulation":25,"armGroups":37,"interventions":55,"overallOfficials":25,"centralContacts":69,"locations":75,"responsibleParty":91,"collaborators":25,"id":95,"slug":25,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":25,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":25,"enrollmentInfo":103,"targetDuration":25,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":78,"whyStopped":25,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"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).","Immediately after the procedure",{"measure":19,"description":20,"timeFrame":21},"Local events at 48 hours","Presence of local side effects such as edema, purpura, and crusting will be documented clinically by the investigators.","48 hours after treatment",{"measure":23,"description":24,"timeFrame":12},"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).",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"RANDOMIZED","CROSSOVER","Crossover Assignment (within-subject comparison of three treatment modalities on different lesion areas)","TREATMENT",{"masking":32,"maskingDescription":25,"whoMasked":33},"DOUBLE",[34,35],"PARTICIPANT","OUTCOMES_ASSESSOR","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.\n\nRecently, 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.\n\nThis 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.\n\nThe 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.\n\nThis study seeks to provide evidence supporting the optimal laser treatment strategy for PWS, potentially improving clinical outcomes and guiding future protocols.",[38,44,49],{"label":39,"type":40,"description":41,"interventionNames":42},"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\u002Fcm² fluence, and 0.5-3 ms pulse duration. Cryogen spray cooling will be used, and no anesthesia will be applied.",[43],"Device: Pulsed dye laser (PDL)",{"label":45,"type":40,"description":46,"interventionNames":47},"Potassium Titanyl Phosphate Laser (KTP)","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\u002Fcm² fluence, and 10 ms pulse duration. Cryogen spray cooling will be used; no anesthesia will be applied.",[48],"Device: Potassium titanyl phosphate (KTP) laser",{"label":50,"type":51,"description":52,"interventionNames":53},"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.",[54],"Device: Sequential KTP + PDL laser treatment",[56,61,65],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":25},"DEVICE","Pulsed dye laser (PDL)","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\u002Fcm² 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.",[39],{"type":57,"name":62,"description":63,"armGroupLabels":64,"otherNames":25},"Potassium titanyl phosphate (KTP) laser","Treatment with a KTP laser at 532 nm using the DermaV® system (Lutronic Medical Systems). Parameters: 10 mm spot size, 8-11 J\u002Fcm² 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.",[45],{"type":57,"name":66,"description":67,"armGroupLabels":68,"otherNames":25},"Sequential KTP + PDL laser treatment","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\u002Fcm², 10 ms), followed by PDL (10 mm spot, 7-9 J\u002Fcm², 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.",[50],[70],{"name":71,"role":72,"phone":73,"phoneExt":25,"email":74},"Jorge Naharro-Rodriguez, M.D.","CONTACT","+34 91 336 80 00","jorgenrmed@gmail.com",[76],{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":80,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Ramon y Cajal University Hospital","RECRUITING","Madrid","Spain","28034","ES",{"type":84,"coordinates":85},"Point",[86,87],-3.70256,40.4165,{"lat":87,"lon":86},[90],{"name":71,"role":72,"phone":73,"phoneExt":25,"email":74},{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Jorge Naharro-Rodriguez","M.D.","100594102",false,"NCT07015073","Comparative of Sequential Application of Pulsed Dye Laser and Potassium-titanyl-phosphate Laser Treatment for Capillary Malformations Versus Single Application","Comparative Efficacy and Tolerability of Pulsed Dye Laser and Potassium-titanyl-phosphate Laser Treatment for Capillary Malformations: Sequential Versus Single Application","Inclusion Criteria:\n\n* Age ≥18\n* Fitzpatrick skin types I-IV\n* Presence of port-wine stain\n\nExclusion Criteria:\n\n* Open wounds in treatment area\n* Pregnancy\n* Nearby metal implants\n* Photodermatoses","ALL","18 Years",{"count":104,"type":105},30,"ESTIMATED","INTERVENTIONAL",[108],"NA","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.",[111],"Port-Wine Stains (Capillary Malformations)",[113,114,115,116,117],"port-wine stains","capillar malformation","laser","pulsed dye laser","KTP laser","2025-06-03",{"date":120,"type":121},"2025-06-11","ACTUAL",{"date":123,"type":121},"2024-12-01",{"date":125,"type":105},"2025-08",{"name":5,"class":6},1]