[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557998":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":25,"responsibleParty":41,"collaborators":25,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":25,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":25,"enrollmentInfo":53,"targetDuration":25,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":64,"whyStopped":25,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":25},{"fullName":5,"class":6},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional photodynamic therapy with red light and methyl aminolevulinate","ACTIVE_COMPARATOR","PDT exposing the area to a red light source for 8 minutes with a spectrum of 630 nm and 37J\u002Fcm2, with the illumination intensity being less than 200 mW\u002Fcm2.",[13],"Other: Full-dose illumination protocol",{"label":15,"type":16,"description":17,"interventionNames":18},"Half-dose illumination protocol photodynamic therapy with red light and methyl aminolevulinate","EXPERIMENTAL","PDT exposing the area to a red light source for 8 minutes with a spectrum of 630 nm and 18,5J\u002Fcm2, with the illumination intensity being less than 200 mW\u002Fcm2.",[19],"Other: Half-dose illumination protocol",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Half-dose illumination protocol","Area will be treated according to the classic protocol, in a single session. First, the surface of the actinic keratoses will be scraped to remove scales and crusts. Using a spatula, a sufficient amount of photosensitizing cream will be applied to cover the treatment area (1 mm thick). The treated area will then be covered with an occlusive dressing for 3 hours. After this interval, the dressing will be removed and the area will be exposed to a red light source for 8 minutes with a spectrum of 630 nm and 18,5J\u002Fcm2, with the illumination intensity being less than 200 mW\u002Fcm2.",[15],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Full-dose illumination protocol","Area will be treated according to the classic protocol, in a single session. First, the surface of the actinic keratoses will be scraped to remove scales and crusts. Using a spatula, a sufficient amount of photosensitizing cream will be applied to cover the treatment area (1 mm thick). The treated area will then be covered with an occlusive dressing for 3 hours. After this interval, the dressing will be removed and the area will be exposed to a red light source for 8 minutes with a spectrum of 630 nm and 37J\u002Fcm2, with the illumination intensity being less than 200 mW\u002Fcm2.",[9],[31],{"name":32,"affiliation":33,"role":34},"Jorge Naharro-Rodriguez, M.D.","No organization","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","913368000","+34","irycis@irycis.org",{"type":34,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Jorge Naharro-Rodriguez","Principal Investigator","100557998","efficacy-and-safety-of-illumination-dose-reduction-in-red-light-photodynamic-therapy-for-actinic-keratoses-100557998",false,"NCT06545396","Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For Actinic Keratoses","Characterization Of The Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For The Treatment Of Actinic Keratoses And Their Cancerization Field","Inclusion Criteria:\n\n* Patient with grade I and II actinic keratoses (AK) of Olsen on the scalp requiring field cancerization treatment.\n* ≥ 18 years old.\n* More than 5 AK per field of cancerization to be treated.\n* More than 6 months since the last field treatment for AK performed.\n* No AK in clinical grade III progression of Olsen or showing signs suggestive of being invasive squamous cell carcinoma.\n\nExclusion Criteria:\n\n* Patients with photodermatoses.\n* Patients sensitive to methyl-aminolevulinate.\n* Patients with disabilities or unable to provide informed consent.\n* Patients who do not tolerate or do not wish to be treated with PDT.","ALL","18 Years",{"count":54,"type":55},20,"ESTIMATED","INTERVENTIONAL",[58],"NA","The goal of this clinical trial is to compare the tolerance and efficacy of conventional photodynamic therapy (PDT) with red light versus PDT with red light at half dose of illumination, as well as the changes produced by both interventions at the biomolecular level in patients with multiple actinic keratosis on the scalp. The main questions it aims to answer are:\n\nDoes PDT with half-dose illumination protocol maintain clinical and biomolecular efficacy?\n\nDoes PDT with half-dose illumination protocol improve intervention tolerance?\n\nResearchers will compare both treatment protocols using the patient as its own control.\n\nParticipants scalp will be divided in two halves, one will be treated with PDT at conventional doses and the other with the half-dose illumination protocol, a skin biopsy will be obtained both pre and post-treatment of each of the areas. Variables will be assessed during the 3 visits of the study.",[61],"Actinic Keratoses",[63],"Photodynamic therapy","NOT_YET_RECRUITING","2024-08-07",{"date":67,"type":68},"2024-08-09","ACTUAL",{"date":70,"type":55},"2024-08",{"date":72,"type":55},"2025-03",{"name":5,"class":6}]