[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"port-wine-stain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:port-wine-stain":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100452468","phase-2-a-study-to-evaluate-efficacy-and-safety-of-light-dose-in-subjects-with-pwb-treated-with-hemoporfin-pdt-100452468",false,"NCT05171894","A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT","A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Sequential Group Comparison Study to Evaluate the Safety and Efficacy of Light Dose in Subjects With Port-wine Birthmarks Treated With Hemoporfin Photodynamic Therapy","Inclusion Criteria:\n\n1. Subject must be 18 to 75 years of age inclusive, at the time of signing the informed consent.\n2. Subject is Fitzpatrick skin type I-VI.\n3. A male subject must agree to use contraception during the Treatment Period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period.\n4. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n   Not a woman of childbearing potential (WOCBP) . OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 30 days after the last dose of study treatment.\n5. The subject has a clinical diagnosis of PWB located i) on the extremities, trunk, caudal cervical and\u002For retroauricular area (Stage One); ii) on the face and\u002For neck (Stage Two).\n6. The longest diameter of the treatment area is ≥3 cm, and the short diameter is ≥2 cm.\n7. Subject is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n8. Subject, in the Investigator's opinion, is in good general health and free of any disease state or physical condition that may impair the evaluation of PWB or expose the subject to an unacceptable risk by study participation.\n9. If the subject has a history of epilepsy or seizure, the disease must remain stable for at least 6 months prior to C1D1.\n\nExclusion Criteria:\n\n1. Subject is pregnant, lactating, or is planning to become pregnant during the study.\n2. Subject has plaque\u002Fnodular changes and severe hypertrophy within the target PWB area.\n3. Subject has Sturge-Weber syndrome.\n4. Subject has any skin pathology or condition that, in the Investigator's opinion, could interfere with the evaluation of the study drug or requires use of interfering topical, systemic, or surgical therapy.\n5. The subject has evidence of scarring within the target PWB area and\u002For the subject has a history of hypertrophic scarring or keloidal scarring.\n6. Subject is immunosuppressed related to medication use and\u002For disease.\n7. The subject has clinical abnormalities, as determined by the Investigator, which makes them unsuitable for receiving study treatment in the Investigator's opinion at Screening.\n8. Subject has received any therapy on the treatment region that, in the Investigator's opinion, may affect the target PWB area.\n9. Subject is known or in the opinion of the Investigator likely to be noncompliant with the requirements of the study protocol (eg, due to alcoholism, drug dependency, mental incapacity).\n10. Subject has a history of either significant neurological events (such as major stroke) or a mental condition rendering him\u002Fher unable to understand the nature, scope, and possible consequences of the study.\n11. Subject has an unstable cardiac disease or has any medical condition that in the opinion of the Investigator may worsen from receipt of study treatment or subject participation.\n12. The subject has a history of cutaneous photosensitization, porphyria, or photodermatosis.\n13. The subject has the need or has plans to be exposed to artificial tanning devices or excessive sunlight during the study.","ALL","18 Years","75 Years",{"count":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multi-center, randomized, double-blind, vehicle-controlled, and sequential group Phase 2 study. Eligible subjects aged 18 to 75 years old with PWB will receive Hemoporfin PDT or vehicle PDT in 8-week cycles at fixed drug dose (5 mg\u002Fkg) and different light fluence.",[27,28,29],"Port-wine Birthmarks","Port-Wine Stain","Nevus Flammeus",[31,27,28,29,32],"Hemoporfin","Photodynamic therapy","RECRUITING","2026-03-02",{"date":36,"type":37},"2026-03-03","ACTUAL",{"date":39,"type":37},"2024-09-21",{"date":41,"type":21},"2027-04",{"name":43,"class":44},"Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.","INDUSTRY",5,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100615270","vbeam-pro-pulse-dye-laser-for-the-treatment-of-vascular-conditions-100615270","NCT07290426","Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions","A Prospective Clinical Study Evaluating Pulse Dye Laser on Clearance of Vascular Indications","Inclusion Criteria:\n\n1. Healthy subjects aged 18 years or older\n2. Presence of one or more vascular lesion, cutaneous lesion, or other dermatological condition deemed fit for treatment\n3. Able and willing to comply with the treatment\u002Ffollow-up schedule and comply with all study (protocol) requirements.\n4. Willing to provide signed, informed consent to participate in the study\n5. Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials\n\nExclusion Criteria:\n\n1. Pregnant or planning to become pregnant, having given birth less than 3 months prior to enrollment into the study, and\u002For breast feeding\n2. Known photosensitivity to 595nm or 1064 nm light\n3. History of light-induced seizure disorders\n4. Severe unstable concurrent conditions, such as unstable cardiac disorders\n5. Use of implanted medical device including pacemakers, cardioverters and other implantable devices or fillers per investigator discretion (consultation with physicians prior to treatment is required)\n6. Use of photosensitizing medications (medications that introduce photosensitivity or medications within or above the 595 nm wavelength, refer to Candela's list of drugs that may cause photosensitivity)\n7. Tattoos (including decorative, permanent makeup and radiation port tattoos) in the intended study treatment area (595nm use only)\n8. Active Herpes Simplex Virus (HSV) in the intended treatment area unless treated with prophylactic medication\n9. The intended treatment area has significant sun exposure within the past 2 weeks or self-tanner has been applied to the treatment area\n10. In the opinion of the Investigator, the subject is unwilling or unable to adhere to the study requirements or is otherwise unsuitable for the study",true,{"count":55,"type":21},40,[57],"NA","This is a clinical study to evaluate the safety and performance of the Vbeam Pro Laser System for the treatment of vascular indications, including rosacea and port wine stain birthmarks.",[60,61,28],"Rosacea","Vascular Diseases","NOT_YET_RECRUITING","2025-12-16",{"date":65,"type":37},"2025-12-18",{"date":67,"type":21},"2026-03",{"date":69,"type":21},"2028-12",{"name":71,"class":44},"Candela Corporation",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"100503927","tolerability-of-532-nm-laser-treatment-of-port-wine-stains-100503927","NCT05841628","Tolerability of 532 nm Laser Treatment of Port Wine Stains","Inclusion Criteria:\n\n1. .Subject must be able to read, understand and sign the Informed Consent Form. 2. Female or Male, 18 to 75 years of age (inclusive). 3. Fitzpatrick Skin Type I - VI. 4. Have non-facial port wine stain covering at least 30cm2 area on the body. 5. Must be willing to have Lutronic DermaV treatments (532 nm) and able to adhere to the treatments, follow-up visit schedule, and post-treatment care instructions.\n\n6\\. Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period.\n\n7\\. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation (educational and\u002For marketing), publications, and any additional marketing purposes.\n\n8\\. Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the treated areas during the study and has no intention of having such procedures performed during the course of the study.\n\n9\\. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.,\n\nExclusion Criteria:\n\n1. Participation in a clinical trial of another drug, or device administered to the treatment area, within 3 months prior to enrollment or during the study.\n2. Any type of prior cosmetic or port wine stain treatment to the target area within 3 months of study participation.\n3. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).\n4. Pregnant and\u002For breastfeeding, or planning to become pregnant.\n5. Significant concurrent illness, such as diabetes mellitus, immunosuppression\u002Fimmune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication.\n6. Hypersensitivity to light exposure.\n7. Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion.\n8. History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising.\n9. Has a history of squamous cell carcinoma or melanoma in the treatment area.\n10. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.\n11. A history or active skin condition that in the opinion of the Investigator may interfere\u002Fconfound with the treatment.\n12. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.\n13. History of disease stimulated by heat, such as recurrent herpes simplex and\u002For herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.\n14. History of pigmentary disorders, particularly tendency for hyper- or hypo- pigmentation, or any that are considered not acceptable by the study investigator.\n15. Excessively tanned or active sun tan in area to be treated, or unable\u002Funlikely to refrain from tanning during the study.\n16. Excessive hair in the area to be treated (beards, sideburns, and\u002For moustache,) that would interfere with diagnosis, assessment, and treatment.\n17. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study, including excessive alcohol or drug abuses, or a condition that would compromise the subject's ability to comply with the study requirements.",{"count":79,"type":21},15,[57],"The goal of this study is to learn about treatment of port wine birthmarks treated with an FDA-approved 532 nm laser.\n\nThe main questions it aims to answer are:\n\n* How well are the treatments tolerated?\n* Are there differences in tolerability of the treatment when a single high fluence laser pulse is used (the standard treatment) versus using multiple low fluence pulses?\n* Are there differences in results when using a single high fluence pulse versus multiple low fluence pulses?\n\ntype of study: Clinical Trial\n\nParticipants will undergo 3 monthly laser treatments with the 532 nm DermaV laser. Part of their birthmark will be treated with the standard single-pulse high fluence approach, and other parts will be treated with the multiple-pulse low fluence approach.",[28],"2025-11-21",{"date":85,"type":37},"2025-11-26",{"date":87,"type":37},"2023-05-01",{"date":89,"type":21},"2026-12",{"name":91,"class":92},"Massachusetts General Hospital","OTHER",1,"Port Wine Stain"]