[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"actinic-keratoses\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:actinic-keratoses":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,41,71,95,118,152,179,202,231,254,276,295],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100395454","phase-2-pdt-vs-peels-for-treatment-of-actinic-keratoses-100395454",false,"NCT04429308","PDT vs Peels for Treatment of Actinic Keratoses","PDT Versus the Combination of Jessner's Solution and 35% TCA for Treatment of Actinic Keratoses on Upper Extremities: A Randomized Controlled Split-arm Trial","Inclusion Criteria:\n\n1. \\>18 years of age\n2. Interested in receiving treatment for actinic keratoses on the bilateral upper arms\n3. In good general health as assessed by the investigator\n4. Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study\n\nExclusion Criteria:\n\n1. Patient pregnant or nursing\n2. Patient with extensive concurrent skin conditions (such as eczema, psoriasis, etc) on upper extremities that would interfere with treatment as determined by the treating physician\n3. Subject unwilling to sign an IRB approved consent form\n4. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible",true,"ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to to compare photodynamic therapy (PDT) versus the combination of Jessner's solution and 35% trichloroacetic acid (TCA) chemical peels for the treatment of actinic keratoses on upper extremities.\n\nThis is a randomized clinical trial. Approximately 60 participants with actinic keratoses on both upper arms will be randomized to have one arm receive photodynamic therapy, while the contralateral arm receives Jessner's solution followed immediately by 35% TCA. AKs will be counted before treatment and 2-8 weeks after treatment. This study is a pilot study designed to determine the feasibility of this procedure.\n\nSubjects currently living in the Chicago metropolitan area and meet inclusion\u002Fexclusion criteria will be considered for enrollment.",[27],"Actinic Keratoses","NOT_YET_RECRUITING","2026-06-29",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":21},"2026-08",{"date":36,"type":21},"2027-12",{"name":38,"class":39},"Northwestern University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100613981","phase-3-efficacy-and-safety-of-cryotherapy-followed-by-tirbanibulin-ointment-for-actinic-keratosis-on-the-scalp-and-forehead-100613981","NCT07273656","Efficacy and Safety of Cryotherapy Followed by Tirbanibulin Ointment for Actinic Keratosis on the Scalp and Forehead","TIRBACRYO","Inclusion Criteria:\n\n* Subject over 18 years old presenting with ≥ 8 typical actinic keratoses (AK), clinically visible or palpable, grade I or II, with at least 4 AK per hemiscalp,\n* Participants who, in the investigator's judgment, are in good general condition (ECOG ≤ 2),\n* The AK must be distributed in 2 non-overlapping areas, and of similar grades,\n* Patient capable of understanding and adhering to the study visit schedule and other protocol requirements,\n* Patient capable of understanding and voluntarily signing informed consent,\n* Patient covered by social insurance,\n* Patient willing to comply with all study procedures and duration,\n* Women of childbearing potential must:\n\nHave a negative pregnancy test at screening and during the treatment period,\n\nUse an effective contraceptive method throughout the study participation. Menopausal women (absence of menstruation for at least one year without other medical cause) or surgically sterile women (tubal ligation, hysterectomy, or bilateral oophorectomy) may be enrolled.\n\nExclusion Criteria:\n\n* Clinically atypical and\u002For rapidly evolving actinic keratoses (AK) in the treatment area, and grade 3 AK according to Olsen classification,\n* A defined treatment area that would be:\n\n  1. Located somewhere other than the scalp and\u002For forehead,\n  2. Within 5 cm of a wound that is not fully healed or a lesion suspicious for carcinoma,\n* Prior treatment with tirbanibulin,\n* Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for actinic keratoses in the treatment area or within 2 cm around this area within 6 weeks prior to the screening visit,\n* Use of the following therapies within 2 weeks prior to the screening visit:\n\n  1. Therapeutic or cosmetic procedures (e.g., liquid nitrogen application, surgical excision, dermabrasion, medium or deep chemical peeling, laser resurfacing) in the treatment area or within 2 cm around the selected treatment area,\n  2. Therapeutic products containing acids (e.g., salicylic acid, fruit acids), topical retinoids, or light peels in the treatment area or within 2 cm around the selected treatment area,\n* Allergy to tirbanibulin or any of its components.\n* Any condition causing a risk of poor compliance,\n* Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign the consent form,\n* Women of childbearing potential who refuse to use an effective contraceptive method,\n* Pregnant women, women planning to become pregnant, and breastfeeding women,\n* Persons deprived of liberty by judicial or administrative decision.",{"count":49,"type":21},59,[51],"PHASE3","The aim of the study is to evaluate the efficacy and safety of a combined approach of cryotherapy and tirbanibulin for the treatment of actinic keratosis of the scalp and forehead, repeated every 4 months. A higher rate of complete response is expected with this combination compared to cryotherapy alone, as well as a better response with repeated treatment cycles.",[54,27],"Keratosis",[56,57,58,59,60,61],"Tirbanibulin","Cryotherapy","Squamus cell carcinoma","Skin carcinoma","Actinic Keratosis","Field cancerization","2026-05-20",{"date":64,"type":32},"2026-05-22",{"date":66,"type":21},"2026-11-30",{"date":68,"type":21},"2028-11-30",{"name":70,"class":39},"University Hospital, Lille",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":40},"100623795","phase-1-actinic-keratoses-treated-with-5-fluorouracil-plus-aluminum-100623795","NCT07401277","Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum","Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum: an Exploratory Study","Inclusion Criteria:\n\n* Less than 50 years due to this being a pathology of adults that develops in chronically sun-damaged skin, individuals \\\u003C50 years of age are excluded from this study.\n* Patients with 4-15 clinically diagnosed AKs on the scalp (16 patients) or on the forearms (16 patients) being followed at the Mohs Surgery clinic by WVU Medicine Dermatology\n* Performance status: ECOG Performance status less than or equal to 2\n* Patient must provide informed consent\n\nExclusion Criteria:\n\n* Presence of a suspected squamous cell carcinoma (SCC) or basal cell carcinoma (BCC) lesion or open wound on the treatment site (scalp or forearm)\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 15% ACH or other agents used in this study\n* Use of one or more of the following products within the past month:\n\n  * Tanning skin colorants\n  * Prescription topical drugs\n  * Immunomodulatory or immunosuppressive medicines\n  * Chemotherapy or cytotoxic medications\n  * Photodynamic therapy (PDT) or other treatments of pre-cancers on the skin\n  * Vitamin A derivatives taken by mouth\n* Patients receiving any other investigational agents\n* Patients with immunosuppression or weakened immune systems who may be at a higher risk of infection, including patients who have had chronic lymphocytic leukemia (CLL), who have received transplants, or who are taking medications such as chronic steroids or rheumatoid arthritis (RA) drugs","50 Years",{"count":80,"type":21},32,[82],"PHASE1","This study is looking at a new way to treat actinic keratoses, which are rough, scaly spots on the skin caused by long-term sun exposure. These spots are common in older adults and, if not treated, can sometimes develop into a type of skin cancer.\n\nDoctors often treat areas with many of these spots by using a prescription cream called 5-fluorouracil (5-FU), which helps remove damaged skin cells. This study is testing whether adding aluminum chloride hexahydrate, a medication commonly used to stop bleeding during skin procedures, can improve how well the cream works.\n\nPeople who take part in this study will receive one of two treatments applied to their skin:\n\nStandard treatment with 5% 5-fluorouracil cream, or A combination of 5% 5-fluorouracil cream plus 15% aluminum chloride hexahydrate cream\n\nThe treatment will be applied for one week. A dermatologist will examine the treated skin areas, count the number of actinic keratoses, and take photographs before treatment begins, shortly after treatment ends, and again about eight weeks later. These visits help researchers compare how well each treatment reduces the number of skin spots over time.\n\nThe goal of this study is to learn whether adding aluminum chloride hexahydrate to standard treatment helps reduce actinic keratoses more effectively than standard treatment alone.",[27],"RECRUITING","2026-04-17",{"date":88,"type":32},"2026-04-22",{"date":90,"type":32},"2026-02-06",{"date":92,"type":21},"2027-08",{"name":94,"class":39},"West Virginia University",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":40},"100545702","investigation-of-the-effect-of-lipikar-baume-apm-100545702","NCT06385340","Investigation of the Effect of Lipikar Baume AP+M","Investigation of the Effect of Lipikar Baume AP+M on Skin Barrier, Microbiome and AKASI of Participants With Actinic Keratoses and Field Cancerization of the Forearms and Hands","Inclusion Criteria:\n\n* Male, female, diverse persons (\\> 18yo) who are capable of giving consent\n* Female patients are eligible if the subject is not a woman of childbearing potential (WOCBP) or if she is postmenopausal (cessation of menstruation \\>12 months) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, total hysterectomy)\n* Signed informed consent\n* Diagnosis of at least 4 actinic keratoses of the the forearm and\u002For back of the hand (each arm)\n* Olsen grade I, II and\u002For III\n* Subjects with similar severity and number of AKs on each side symmetrically\n* The study participant is in good general condition for his or her age and does not currently have any active diseases that, in the opinion of the investigator, justify exclusion from the study\n\nExclusion Criteria:\n\n* Known or documented intolerance to any of the ingredients of Lipikar Baume AP+M\n* Any planned AK treatment during the study\n* Treatment of actinic keratoses in the application area within the past 3 Months (e.g. photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy etc.)\n* Suspected invasive squamous cell cancer in the application area\n* Chronic wounds, erosions, pre-existing infected skin or inflammation which, in the opinion of the investigator, are in need of treatment other than the study product\n* Suspected non-compliance\n* Current or within the last 8 weeks given systemic cancer medication or systemic treatment with 5-Fluorouracil\n* Any systemic immunosuppressant given within the 8 weeks prior to the study (e.g. systemic prednisolone, azathioprine etc.)\n* Locally applied retinoids, steroids, or other prescribed externals in the 4 weeks prior to the start of the study that, in the opinion of the study physician, necessitate exclusion\n* Products containing glycolic or alpha-hydroxy acids applied locally in the application area in the last 4 weeks\n* Participation in another clinical trial\n* Participation in a clinical study within the last 30 days\n* Family members or colleagues of the investigator\n* Participant is in a position or has a relationship with the investigator that presents a potential conflict of interest",{"count":103,"type":21},20,[105],"NA","Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme The purpose of this study is to observe the skin barrier function, transepidermal water loss and microbial changes in study participants with actinic field damage of both arms.\n\nIt's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion\u002Fexclusion criteria.\n\nA total of 20 subjects will be enrolled.\n\nThe study design consists in 4-week evaluation period, with 2 visits per subject: Screening\u002FBaseline (Day 0, Day 28 (end of Lipikar Baume AP+M application)).",[27],"2025-07-08",{"date":110,"type":32},"2025-07-11",{"date":112,"type":32},"2024-04-23",{"date":114,"type":21},"2025-11-30",{"name":116,"class":117},"CentroDerm GmbH","NETWORK",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":40},"100540758","systematical-trained-learning-algorithms-for-oral-carcinogenesis-interpretation-by-optical-coherence-tomography-100540758","NCT06321003","SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography","Single-blind Clinical Trial Assessing the Validity of Optical Coherence Tomography (OCT) in Diagnosing Potentially Malignant Oral Lesions and Oral Cancer","SYMILIS OCT","Inclusion Criteria:\n\n1. Adult patients with clinical suspicion of potentially malignant oral disorders (OPMDs) and oral squamous cell carcinoma (OSCC).\n2. Patients able to provide informed consent for participation in the study.\n3. Availability of complete clinical data and medical records.\n\nExclusion Criteria:\n\n1. Patients with a previous diagnosis of OSCC\u002FOPMDs and\u002For who have already undergone treatment.\n2. Patients with contraindications to the OCT examination for nonpermissive oral localization using the probe.\n3. Pregnant or breastfeeding women.\n4. Patients with disabilities, reluctance or difficulties of understanding to follow the procedures of the study and who have not provided a consent.","99 Years",{"count":128,"type":21},200,"OBSERVATIONAL","This clinical trial aims to assess the efficacy of Optical Coherence Tomography (OCT) in the early diagnosis of oral cancer. It focuses on Oral Potentially Malignant Disorders (OPMDs) as precursors to Oral Squamous Cell Carcinoma (OSCC). Despite the availability of oral screening, diagnostic delays persist, underscoring the importance of exploring non-invasive methodologies. The OCT technology provides cross-sectional analysis of biological tissues, enabling a detailed evaluation of ultrastructural oral mucosal features.\n\nThe trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on OCT, enhancing its ability to detect characteristic patterns such as the keratinized layer, squamous epithelium, basement membrane, and lamina propria in oral tissues affected by OPMDs and OSCC.\n\nFurthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological analysis, adopting a site-specific approach in biopsies to improve correspondence between data collected by both methods.\n\nIn summary, the trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice.",[132,133,134,135,136,137,138,139,27,140,141,142],"Oral Squamous Cell Carcinoma","Oral Potentially Malignant Disorder","Oral Leukoplakia","Proliferative Verrucous Leukoplakia","Oral Lichen Planus","Oral Lichenoid Lesion","Graft-versus-host-disease","Oral Erythroplakia","Actinic Cheilitis","Oral Cancer","Oral Disease","2025-05-19",{"date":145,"type":32},"2025-05-23",{"date":147,"type":32},"2024-03-13",{"date":149,"type":21},"2028-04-01",{"name":151,"class":39},"University of Palermo",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":164,"conditions":165,"keywords":166,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100554463","phase-4-combination-therapy-of-5-fluorouracil-and-calcipotriol-versus-5-fluorouracil-in-the-treatment-of-actinic-keratosis-100554463","NCT06499415","Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis","Combination Therapy of 5-Fluorouracil and CALcipotriol Versus 5-Fluorouracil in the Treatment of Actinic Keratosis: a Multicentre Randomized Controlled Clinical Trial","CALM","Inclusion Criteria:\n\n* Adults above 18 years of age\n* Clinical and dermoscopical diagnosis of AK by a dermatologist, in one or more area(s):\n\n  * Face, ears, (balding) scalp\n  * Neck\u002FShawl area, including the sun-exposed chest area\n  * Upper extremities\n* Number of AK lesions ≥4 in a continuous treatment area of up to 100 cm2\n* AK Olsen grade I-III\n\nExclusion Criteria:\n\n* Previous field treatment for AK within 2cm of the treatment area, within 3 months\n* (non) melanoma skin cancer in treatment area\n* Mucosal lesions\n* Genetic skin cancer disorder\n* Women who are pregnant or breastfeeding\n* Women of childbearing potential, who are not willing to use effective contraceptive measures\n* Previous allergy or intolerance to either 5FU or calcipotriol\n* Patients with known contra-indications for calcipotriol use: previous diagnosis of hyper-calcemia, disturbed calcium metabolism, severe kidney or liver dysfunction\n* Concurrent use of oral capecitabine or any other topical or systemic chemopreventive agent for any indication\n* Concurrent use of other topical treatments registered as treatment for AK\n* Limited understanding of the Dutch language and not being able to give informed consent (incapacitated patients)",{"count":161,"type":21},232,[163],"PHASE4","5-Fluorouracil (5FU) is proven to be the most effective therapy in field directed treatment for AK, with Jansen et al. reporting a 1-year probability of treatment success of 74.7%. However, treatment with 5FU is associated with side effects, like erythema, itching, a burning sensation and crusting, and a burdensome dosing regimen of twice daily application for four weeks. This long treatment duration in combination with side-effects and overall lifestyle adjustments during treatment can be the reason for poor adherence and premature termination, and it can also lead to future refusal of 5FU therapy. Therefore, room for improvement lies in increasing the tolerability, in terms of side effects or treatment duration, while maintaining the efficacy of 5FU in the treatment of AK.\n\nAddition therapy, which can shorten the duration of treatment, might be the key to success. Calcipotriol (CAL) enhances thymic stromal lymphopoietin (TSLP), an epithelium-derived cytokine, which promotes antitumor immunity. Therefore, it is known to have a synergistic effect when combined with 5FU in the treatment of AK. This suggests that short-term treatment with 5FU-CAL is effective and provides the opportunity to shorten duration of treatment, thereby improving tolerability of treatment and full adherence to the treatment regimen.\n\nHowever, no study compared 5FU-CAL combination therapy with standard 5FU treatment for a duration of 28 days. This study aims to evaluate whether a short course of combination therapy with 5FU-CAL is non-inferior to a full course of 5FU monotherapy with respect to the 1-year probability of treatment success.",[27],[167,168],"5-Fluorouracil","Calcipotriol","2025-05-07",{"date":171,"type":32},"2025-05-11",{"date":173,"type":32},"2024-09-04",{"date":175,"type":21},"2029-03-02",{"name":177,"class":39},"Maastricht University Medical Center",4,{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":185,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":40},"100355308","effectiveness-of-fractionated-laser-resurfacing-to-protect-geriatric-skin-from-actinic-neoplasia-100355308","NCT03906253","Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia","Inclusion Criteria:\n\n* Diagnosed with Actinic Keratosis within the past 6 months\n* At least 60 years of age, or older\n* Ability to comprehend procedures and risks versus benefits\n* Able to provide Informed Consent\n* Fair Skin (Fitzpatrick Type I or II)\n* Possess both Right and Left Forearms\n\nExclusion Criteria:\n\n* Uncontrolled Diabetes Mellitus\n* Not able to comprehend procedures or risks versus benefits\n* Pregnant or nursing\n* Large tattoos on forearms\n* History of abnormal healing or scarring (i.e., keloids)\n* Any disease that gets worse while in the sun\n* Use of topical or oral anti-inflammatory medication or steroids\n* Allergy to lidocaine\n* Current use of photosensitizing medication","60 Years",{"count":187,"type":21},72,[105],"This study is following up on previous studies that have demonstrated that geriatric subjects respond different to ultraviolet B (UVB) light than young subjects. The treatment of geriatric skin with dermal rejuvenation therapies (dermabrasion, fractionated laser resurfacing) restores the appropriate UVB response. Ongoing studies have tested the ability of fractionated laser resurfacing (FLR) to assess how long this wounding effect lasts-and have found that this appears to be a durable response which lasts for at least two years. The findings that FLR protects geriatric skin at two years is the impetus for this study.\n\nThis study is an interventional study to assess if FLR treatment of one forearm of geriatric subjects with multiple actinic keratosis will result in the short-term removal of actinic keratosis, and the long-term decrease in levels of future actinic keratosis and other non-melanoma skin cancers in comparison to the untreated arm.\n\nStudy length and visit: The first part of the study is completed in 1 day then there are follow up visits at 90 days and every 6 months for 5 years.",[27,191,192],"Aging","Non-Melanoma Skin Cancer","2025-03-24",{"date":195,"type":32},"2025-03-25",{"date":197,"type":32},"2018-01-10",{"date":199,"type":21},"2028-12",{"name":201,"class":39},"Wright State University",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":211,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":4},"100568773","efficacy-of-topical-5-fluorouracil-vs-calcipotriol-as-photodynamic-therapy-pre-treatment-for-field-actinic-keratoses-100568773","NCT06685588","Efficacy of Topical 5-Fluorouracil Vs Calcipotriol As Photodynamic Therapy Pre-treatment for Field Actinic Keratoses","Efficacy of Topical 5-FUvs Calcipotriol As PDT Pre-treatment for Field Actinic Keratoses","Inclusion Criteria:\n\n* Adult (\\>18 years old)\n* Field actinic keratoses on scalp\n* Generally good health\n\nExclusion Criteria:\n\n* Immunosuppression\n* Unable to provide consent\n* Abnormal photosensitivity\n* Contact allergy to metvix \u002F 5-FU \u002F calcipotriol \u002F topical corticosteroids\n* Pregnancy or breastfeeding",{"count":210,"type":21},50,[105],"The purpose of this study is to compare two different creams (5-fluorouracil, known as Efudix, and calcipotriol, known as Dovonex) to see which one works better when used before Photodynamic Therapy (PDT) to treat sun-damaged skin on the scalp (called actinic keratoses).\n\nPDT is often used on its own to treat these spots, but it doesn't always remove them completely. Using Efudix or Dovonex before PDT might improve the results, but we don't yet know which is better.\n\nThe main questions are -\n\n1. Is efudix or dovonex better at treating actinic keratoses when used prior to PDT\n2. Is efudix or dovonex more tolerable for patients?\n\nParticipants will be randomised to treat their scalp with efudix or dovonex for seven days prior to their first PDT treatment. They will be reviewed on day 7, prior to starting PDT, and again a week later when they present for their second PDT treatment.\n\nDuring follow up, patients will be reviewed at 28 days, 3, 6, 9, and 12 months after treatment.\n\nAt each of these visits, the number of actinic keratoses will be counted, graded, mapped and photographed to allow assessment of improvement before and after treatment.",[214,27],"Actinic Keratosis of Face and Scalp",[216,217,218,219,220,221],"efudix","dovonex","5-fluorouracil","calcipotriol","actinic keratosis","actinic keratoses","2024-11-10",{"date":224,"type":32},"2024-11-12",{"date":226,"type":21},"2025-01",{"date":228,"type":21},"2026-01",{"name":230,"class":39},"St Vincent's University Hospital, Ireland",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":16,"sex":17,"minAge":238,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":4},"100555096","methyl-aminolevulinate-8-and-16-incubated-by-1-and-3-for-actinic-keratoses-treatment-100555096","NCT06507644","Methyl Aminolevulinate 8% and 16% Incubated by 1 and 3 for Actinic Keratoses Treatment","Efficacy of Topical Application of Methyl Aminolevulinate 8% and 16% Mediated by Red Light and Incubation Time of 1 and 3 Hours in the Treatment of Actinic Keratoses on the Face: A Double-Blind Randomized Controlled Clinical Protocol","Inclusion Criteria:\n\n* Individuals of both sexes,\n* Aged between 40 and 90 years,\n* Fitzpatrick skin phototypes I to IV,\n* Photodamaged skin with at least five clinically evident actinic keratosis lesions on the face to be treated,\n* No prior treatment for at least six months.\n\nExclusion Criteria:\n\n* Clinically diagnosed infiltrative lesions, as the gold standard treatment is surgical with histopathological evaluation of the lesion (surgery will be performed at no cost to the participant), who will receive guidance and referral for appropriate treatment.\n* Photosensitive diseases, such as systemic lupus erythematosus, dermatomyositis, porphyria, among others.\n* History of arsenic exposure,\n* Known allergy to MAL or similar photosensitizing agents,\n* Psychoactive drug abuse,\n* Previous radiotherapy at the lesion site(s),\n* Participation in another clinical trial,\n* Intense tanning at the time of treatment,\n* Pregnant or breastfeeding women,\n* Local or systemic infection,\n* Immunosuppression: uncompensated chronic diseases or emotional disorders considered contraindications to treatment,\n* Skin conditions on the neck and anterior chest.","40 Years","90 Years",{"count":241,"type":21},144,[105],"The objective of this protocol is to compare the efficacy of the topical application of MAL at concentrations of 8% and 16%, mediated by red light, as well as to evaluate the impact of different incubation times (1 or 3 hours) in the treatment of actinic keratoses on the face, with a 6-month follow-up. This parallel-arm, 6-month follow-up randomized controlled clinical trial will consist of 4 groups: G1 - Control Group - MAL 16% irradiated with 643nm and 75J\u002Fcm² and 3-hour incubation time (n=36), G2 - MAL 16% and 1-hour incubation (n=36), G3 - MAL 8% - 3 hours (n=36), and G4 - MAL 8% - 1 hour (n=36). The researcher conducting the collection and the participant will be blinded to the interventions. The primary outcome will be the complete remission of the lesion at 6 months. Secondary outcomes will include treatment success (75% reduction in the initial number of lesions), recurrence rate, emergence of SCC, incidence of adverse effects, and improvement in skin texture, wrinkles, and pigmentation using a validated scale. All outcomes will be assessed at 30 days, 3, and 6 months. Quality of life will be evaluated using the Actinic Keratosis Quality of Life questionnaire (AKQoL) at 6 months.",[27],"2024-10-09",{"date":247,"type":32},"2024-10-15",{"date":249,"type":21},"2024-11-30",{"date":251,"type":21},"2026-05-30",{"name":253,"class":39},"University of Nove de Julho",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":265,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":4},"100557998","efficacy-and-safety-of-illumination-dose-reduction-in-red-light-photodynamic-therapy-for-actinic-keratoses-100557998","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.",{"count":103,"type":21},[105],"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.",[27],[266],"Photodynamic therapy","2024-08-07",{"date":269,"type":32},"2024-08-09",{"date":271,"type":21},"2024-08",{"date":273,"type":21},"2025-03",{"name":275,"class":39},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":17,"minAge":185,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":40},"100549031","the-preventive-role-of-fractionated-laser-resurfacing-against-actinic-neoplasia-in-an-at-risk-geriatric-population-100549031","NCT06428721","The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population","Inclusion Criteria:\n\n* Adult Males and Females aged 60 and older\n* Have at least 5 AKs on each forearm\u002Fwrist, but no more than 10 to allow for easy monitoring\n* Skin type fair (Fitzpatrick I-II)\n* Females must be post-menopausal and not be on systemic hormone replacement therapy\n* Able to comprehend procedures and risks\n\nExclusion Criteria:\n\n* More than 10 AKs on an extremity\n* AKs that are large (2-3+, hyperkeratotic grade 3 lesions)\n* AKs that are very thick (\\>3 mm)\n* Medical history of diabetes\n* History of poor wound healing or scarring\n* Large tattoos that can interfere with study\n* Other serious health issues and other skin diseases that could interfere with the study\n* Recent (within 1 year) field therapies such as efudex cream or PDT to forearms\u002Fwrists.\n* Planning to leave region in next 5 years\n* Subjects with allergies to xylocaine will be excluded if they need this topical anesthetic.",{"count":283,"type":21},80,[105],"The purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm\u002Fwrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. This study builds on a similar study ongoing at the Dayton Veterans Administration dermatology clinic. This study is also testing if a photograph of the skin can be used to predict where the AKs and an skin cancers will form.",[27,191,192],"2024-07-23",{"date":289,"type":32},"2024-07-24",{"date":291,"type":32},"2024-03-20",{"date":293,"type":21},"2031-12",{"name":201,"class":39},{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":307,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":40},"100537168","effect-of-lipikar-urea-30-before-actinic-keratoses-treatment-100537168","NCT06274320","Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment","Investigation of the Effect of a 2 Weeks Lipikar Urea 30% Application Preceding a Planned Topical 5-FU 4% Actinic Keratoses Treatment on Efficacy of 5-FU 4%","Inclusion Criteria:\n\n* diagnosis of at least 4 non-hypertrophic, non-hyperkeratotic actinic keratosis of the the scalp\n* planned treatment of actinic keratoses of the scalp with Tolak®\n* Olsen grade I or II\n\nExclusion Criteria:\n\n* known or documented intolerance to any of the ingredients of Tolak® or Lipikar Urea 30%\n* treatment of actinic keratoses in the treatment area within the past 3 months (e.g. photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy etc.)\n* suspected invasive squamous cell cancer in the treatment area\n* chronic wounds, erosions, pre-existing inflamed or infected skin with disruption of the epidermal barrier in the treatment area current or within the last 8 weeks given systemic cancer medication or systemic treatment with 5-Fluorouracil",{"count":303,"type":21},100,[105],"This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion\u002Fexclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment.",[27],[221,308,309],"Lipikar Urea 30%","Olsen grade","2024-06-14",{"date":312,"type":32},"2024-06-18",{"date":314,"type":32},"2024-04-05",{"date":316,"type":21},"2025-06",{"name":318,"class":319},"Cosmetique Active International","INDUSTRY"]