[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626513":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":41,"locations":48,"responsibleParty":89,"collaborators":30,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":30,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":30,"maxAge":99,"enrollmentInfo":100,"targetDuration":30,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":116,"whyStopped":30,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"AFT Pharmaceuticals, Ltd.","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"0.6% rapamycin","EXPERIMENTAL","0.6% rapamycin cream applied daily",[13,14],"Drug: Rapamycin cream","Procedure: Pulsed dyed laser",{"label":16,"type":10,"description":17,"interventionNames":18},"1.0% rapamycin cream","1.0% rapamycin cream applied daily",[13,14],{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo cream","PLACEBO_COMPARATOR","Placebo cream applied daily",[14],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Rapamycin cream","Application of rapamycin cream to port wine birthmark",[9,16],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"PROCEDURE","Pulsed dyed laser","Pulsed dyed laser (PDL) treatment of port wine birthmark",[9,16,20],[37],{"name":38,"affiliation":39,"role":40},"Ioana Stanescu","AFT Pharmaceuticals","STUDY_DIRECTOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Laura Boddington, PhD","CONTACT","+6494880232","735","laura.boddington@aftpharm.com",[49,70],{"facility":50,"status":30,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Driscoll Children's Hospital","Corpus Christi","Texas","78411","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-97.39638,27.80058,{"lat":60,"lon":59},[63,67],{"name":64,"role":44,"phone":65,"phoneExt":30,"email":66},"Erin Richmond, MS, RN, CCRP","361-694-5978","erin.richmond@dchstx.org",{"name":68,"role":69,"phone":30,"phoneExt":30,"email":30},"Denise Metry, MD","PRINCIPAL_INVESTIGATOR",{"facility":71,"status":30,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Sant Joan de Déu University Hospital","Barcelona","Catalonia","08950","Spain","ES",{"type":57,"coordinates":78},[79,80],2.15899,41.38879,{"lat":80,"lon":79},[83,87],{"name":84,"role":44,"phone":85,"phoneExt":30,"email":86},"Study Coordinator - Unitat d'Investigacio Clinica","+34 670989833","mateu.torres@sjd.es",{"name":88,"role":69,"phone":30,"phoneExt":30,"email":30},"Marta Ivars, MD",{"type":90,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100626513","phase-2-rapamycin-dose-ranging-efficacy-study-in-port-wine-stains-100626513",false,"NCT07436611","Rapamycin Dose-Ranging Efficacy Study in Port Wine Stains","Rapamycin Dose-Ranging Efficacy Study: A Phase II, Proof of Concept, Double-blind, Placebo-controlled, Randomized, Parallel-group, Dose-response Comparison of the Effects of Different Strengths of Rapamycin Cream Applied Topically in Subjects Diagnosed With Port Wine Stains","Inclusion Criteria:\n\n1. Male and female patients aged ≤ 10 years on the day informed consent is obtained\n2. Patients presenting either facial, neck, or upper trunk port-wine stains\n3. Port wine stain size of at least 5 cm tall x 2.5 cm wide (2x1 inches)\n4. Patients (or their legal representatives) capable of understanding the explanation of the clinical trial, and who give written informed consent for participation\n5. Patients (or their legal representatives) able to maintain patient diaries following the instructions of the investigator or sub-investigator\n6. Patients (or their guardians) are willing and able to follow instructions to only apply cream to part of their port-wine stain\n7. Skin type classified as either I, II, III or IV on the Fitzpatrick scale\n8. Patients who are indicated for PDL treatment and accept this treatment\n9. Patients who respond to PDL with purpura or blanching\n\nExclusion Criteria:\n\n1. Skin type classified as either V or VI on the Fitzpatrick scale\n2. Patients with PWS in extremities and\u002For acral areas\n3. Patients unwilling or unable to carry out the treatment plan or follow-up assessment\n4. Patients with serious skin lesions such as erosions or ulcers\n5. Patients with known hypersensitivity to any component of the study product\n6. Patients who have received rapamycin\u002Fsirolimus, everolimus, or temsirolimus within 3 months of enrolment\n7. Patients who have received laser therapy or surgical therapy to treat PWS within 3 months prior to trial enrolment\n8. Patients who have received 5 or more PDL treatments previously\n9. Patients who participated in any other clinical trial within 3 months prior to the day of enrolment\n10. Patients judged unsuitable for this clinical trial by the investigator or sub-investigator\n11. Pregnant or lactating females\n12. Sexually active females of childbearing potential not using adequate contraception and sexually active males not using adequate contraception\\*\n13. Patients with immune dysfunction or receiving any form of immunosuppression","ALL","10 Years",{"count":101,"type":102},30,"ESTIMATED","INTERVENTIONAL",[105],"PHASE2","The goal of this clinical trial is to learn if the use of rapamycin cream can be used as a treatment together with pulsed dyed laser in treating port wine stain birthmarks. The main question it aims to answer is:\n\nWill rapamycin cream and laser treatment show a greater improvement in appearance of port wine birthmarks, compared to treatment with placebo cream and laser?\n\nResearchers will compare two concentrations of rapamycin cream (0.6% or 1.0%) with placebo treatment to see if appearance is improved following 12 weeks of treatment.\n\nParticipants will receive laser treatment of their port wine birthmark and then apply the rapamycin or placebo cream daily for 12 weeks. Patients will visit the clinic every 4 weeks for checkups and tests.",[108],"Port Wine Stains",[110,111,112,113,114,115],"sirolimus","rapamycin","adjunct therapy","proof of concept","phase 2","dose ranging","NOT_YET_RECRUITING","2026-06-29",{"date":119,"type":120},"2026-07-01","ACTUAL",{"date":122,"type":102},"2026-08",{"date":124,"type":102},"2027-10",{"name":5,"class":6},2]