[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"actinic-keratosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:actinic-keratosis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,80,100,122,145],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100642565","therapeutic-induction-of-dermal-remodeling-in-veterans-to-prevent-actinic-neoplasia-caused-by-chronic-environmental-exposure-to-ultraviolet-radiation-100642565",false,"NCT07648407","Therapeutic Induction of Dermal Remodeling in Veterans to Prevent Actinic Neoplasia Caused by Chronic Environmental Exposure to Ultraviolet Radiation","Inclusion Criteria:\n\n* Adult Males and Females age 60 and older with 5 or more AKs on each forearm\n* Skin type fair-Fitzpatrick I-II\n* Able to comprehend procedures and risks\n\nExclusion Criteria:\n\n* More than 10 AKs on an extremity, or AKs that are large (2-3+)\n* Medical history of Diabetes\n* Coagulopathy or easy bleeding\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\n* Planning to leave region in next 4 years","ALL","60 Years",{"count":18,"type":19},96,"ESTIMATED","INTERVENTIONAL",[22],"NA","The investigators' previous studies demonstrate geriatric subject skin responds differently to ultraviolet B (UVB) light compared to young subject skin, which contribute to increased rates of nonmelanoma skin cancer (NMSC) and actinic keratosis (AK) development in geriatric populations. Previously, the investigators have shown that therapeutic dermal remodeling interventions (e.g., fractionated laser resurfacing and microneedling) can restore appropriate skin responses to UVB in geriatric skin. The investigators also demonstrated fractionated laser resurfacing (FLR) reduced rates of NMSC and AK development (compared to untreated control skin) in at risk geriatric subjects.\n\nThis interventional study will assess the ability of two therapeutic dermal remodeling therapies, microneedling and trichloroacetic acid chemical (TCA) peel, to impact NMSC and AK development in at risk geriatric subjects. Geriatric subjects will be enrolled into one of two study groups. In the first group, one arm will be treated with microneedling and the other arm will not be treated on day 1. In the second group, one arm will be treated with TCA peel and the other arm will not be treated on day 1. Subjects will subsequently be monitored for number of NMSC and AK on treated and untreated (control) forearms in each group. In addition to monitoring NMSC and AK development, subjects at the Richard L. Roudebush VAMC will undergo skin punch biopsy at one of their follow up visits for microscopic and molecular analyses of treated and untreated skin.",[25,26],"Nonmelanoma Skin Cancer","Actinic Keratosis",[28,29,30,31,32],"Nonmelanoma skin cancer","Actinic keratosis","Ultraviolet light","Microneedling","Chemical peel","NOT_YET_RECRUITING","2026-06-09",{"date":36,"type":37},"2026-06-15","ACTUAL",{"date":39,"type":19},"2026-10-01",{"date":41,"type":19},"2030-09-30",{"name":43,"class":44},"VA Office of Research and Development","FED",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":20,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100604040","phase-3-study-of-reformulated-levulan-kerastick-plus-pdt-for-actinic-keratosis-on-face-and-scalp-100604040","NCT07144345","Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp","Randomized, Multi-Center, Evaluator-Blind, Vehicle-Controlled Study to Evaluate Efficacy and Safety of Reformulated Levulan Kerastick Plus Photodynamic Therapy (PDT) for Field-Directed Treatment in Patients With Actinic Keratosis (AK) of Face and (Bald) Scalp","Inclusion Criteria:\n\n1. Patient is a male or non-pregnant female aged 18-85 years.\n2. Patient must have 4-8 mild to moderate actinic keratosis (AK) lesions (Olsen grade 1 or 2) in a single treatment area (either face or bald scalp, not both), each ≤1 cm in diameter and spaced at least 1 cm apart. \\[The treatment area should be approximately 25 cm², excluding sensitive facial regions (eyes, lips, nostrils, ears, mouth)\\]\n3. Patients must be in good general health, avoid sunbathing or tanning devices, and maintain a consistent skincare routine throughout the study.\n4. Patient is willing to stop using all topical products within the Treatment Area within 8 hours of a scheduled clinic visit with an efficacy evaluation.\n5. Women of childbearing potential must use highly effective contraception; men with such partners must use barrier methods unless surgically sterile.\n\nExclusion Criteria:\n\n1. Presence of Olsen grade 3 AK, untreated or suspicious skin cancers, or significant skin abnormalities (e.g., psoriasis, eczema) in the treatment area.\n2. Active herpes simplex infection or history of ≥2 outbreaks in the treatment area within the past year.\n3. History of cutaneous photosensitization, porphyria, photodermatosis, or hypersensitivity to porphyrins.\n4. Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result\n5. Immunosuppressed status (e.g., HIV, organ transplant) or known coagulation defects.\n6. Use of specific topical therapies (e.g., retinoids, steroids, cryotherapy, PDT, chemical peels) on the treatment area within 2 days to 8 weeks prior to randomization.\n7. Recent use of certain systemic therapies (e.g., corticosteroids, immune-modulators, retinoids, cytotoxic drugs) within 6 weeks to 6 months prior to randomization.\n8. Recent use of hypericin or other phototoxic\u002Fphotoallergic medications (e.g., tetracyclines, psoralenes, St. John's wort) within 8 weeks of randomization.\n9. Clinically significant or unstable illnesses, or history of alcohol\u002Fdrug abuse in the past year.\n10. Pregnancy\u002Flactation, recent or current participation in another clinical study, or any other condition deemed unsuitable by the Investigator.","18 Years","85 Years",{"count":56,"type":19},160,[58],"PHASE3","This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study evaluates the efficacy and safety of reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for field-directed treatment of actinic keratosis (AK) on the face or bald scalp. Approximately 160 adult patients with 4-8 mild to moderate AK lesions will be randomized into four treatment arms based on two variables: type of treatment (active drug or vehicle) and incubation time. During the study, up to 2 PDT sessions may be administered depending on the clearance of lesions. The primary endpoint is complete clearance rate (CCR) at Week 12. Secondary endpoints include AK clearance rate (AKCR), partial clearance, change in total lesion count and area, recurrence rate, cosmetic response, and patient satisfaction. Safety assessments include adverse events, local skin reactions, vital signs, and lab tests.",[26],[62,63,64,65,66,67],"Blue Light Photodynamic Therapy","Skin Diseases","Precancerous Conditions","Photosensitizing Agents","Dermatologic Agents","Aminolevulinic Acid","RECRUITING","2026-04-20",{"date":71,"type":37},"2026-04-22",{"date":73,"type":37},"2025-11-19",{"date":75,"type":19},"2027-04",{"name":77,"class":78},"Sun Pharmaceutical Industries, Inc.","INDUSTRY",10,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":54,"enrollmentInfo":87,"targetDuration":4,"studyType":20,"phases":89,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":98,"locationsCount":99},"100604079","phase-3-study-of-reformulated-levulan-kerastick-plus-pdt-for-actinic-keratosis-on-upper-extremities-100604079","NCT07144852","Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities","Randomized, Multi-Center, Evaluator-Blind, Vehicle-Controlled Study to Evaluate Efficacy and Safety of Reformulated Levulan Kerastick Plus Photodynamic Therapy (PDT) for Field-Directed Treatment in Patients With Actinic Keratosis (AK) of Upper Extremities","Inclusion Criteria:\n\n1. Patient is a male or non-pregnant female aged 18-85 years.\n2. Patient must have 4-8 mild to moderate actinic keratosis (AK) lesions (Olsen grade 1 or 2) in a single treatment area on their Index arm, each measuring up to 1 cm in diameter and spaced at least 1 cm apart.\n\n   \\[The treatment area should be approximately 25 cm², located on the extensor surface of only one of the upper extremities that is selected as the Index arm\\]\n3. Patients must be in good general health, avoid sunbathing or tanning devices, and maintain a consistent skincare routine throughout the study.\n4. Patient is willing to stop using all topical products within the Treatment Area within 8 hours of a scheduled clinic visit with an efficacy evaluation.\n5. Women of childbearing potential must use highly effective contraception; men with such partners must use barrier methods unless surgically sterile.\n\nExclusion Criteria:\n\n1. Presence of Olsen grade 3 AK, untreated or suspicious skin cancers, or significant skin abnormalities (e.g., psoriasis, eczema) in the treatment area.\n2. Active herpes simplex infection or history of ≥2 outbreaks in the treatment area within the past year.\n3. History of cutaneous photosensitization, porphyria, photodermatosis, or hypersensitivity to porphyrins.\n4. Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result\n5. Immunosuppressed status (e.g., HIV, organ transplant) or known coagulation defects.\n6. Use of specific topical therapies (e.g., retinoids, steroids, cryotherapy, PDT, chemical peels) on the treatment area within 2 days to 8 weeks prior to randomization.\n7. Recent use of certain systemic therapies (e.g., corticosteroids, immune-modulators, retinoids, cytotoxic drugs) within 6 weeks to 6 months prior to randomization.\n8. Recent use of hypericin or other phototoxic\u002Fphotoallergic medications (e.g., tetracyclines, psoralenes, St. John's wort) within 8 weeks of randomization.\n9. Clinically significant or unstable illnesses, or history of alcohol\u002Fdrug abuse in the past year.\n10. Pregnancy\u002Flactation, recent or current participation in another clinical study, or any other condition deemed unsuitable by the Investigator.",{"count":88,"type":19},260,[58],"This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study evaluates the efficacy and safety of reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for field-directed treatment of actinic keratosis (AK) on the upper extremities. Approximately 260 adult patients with 4-8 mild to moderate AK lesions on one arm will be randomized to receive either active treatment or vehicle control, followed by exposure to blue light. During the study, up to 2 PDT sessions may be administered depending on the clearance of lesions. The primary endpoint is complete clearance rate (CCR) at Week 12. Secondary endpoints include AK clearance rate (AKCR), partial clearance, change in total lesion count and area, recurrence rate, cosmetic response, and patient satisfaction. Safety assessments include adverse events, local skin reactions, vital signs, and lab tests.",[26],[93],"Blue Light Photodynamic Therapy, Skin Diseases, Precancerous Conditions, Photosensitizing Agents, Dermatologic Agents, Aminolevulinic Acid",{"date":71,"type":37},{"date":96,"type":37},"2025-11-29",{"date":75,"type":19},{"name":77,"class":78},20,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":20,"phases":109,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":4},"100632420","phase-2-a-phase-2-study-of-hw211026-in-participants-with-actinic-keratosis-100632420","NCT07513454","A Phase 2 Study of HW211026 in Participants With Actinic Keratosis","A Multicenter, Randomized, Open-label, Parallel-group, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HW211026 Ointment in Patients With Actinic Keratosis.","Key Inclusion Criteria:\n\n* Aged ≥ 18 years, male or female.\n* At least 2 clinically typical target actinic keratosis lesions on the face.\n* Willing to avoid direct sun or ultraviolet exposure to the treatment area during the trial.\n* Fully informed about the study, voluntarily sign the informed consent form, and be able to comply with study procedures and follow-up examination requirements.\n\nKey Exclusion Criteria:\n\n* Clinically atypical and\u002For rapidly changing actinic keratosis lesions, such as hypertrophic lesions, hyperkeratotic lesions, and\u002For cutaneous horns.\n* Presence of incompletely healed wounds or suspected squamous cell carcinoma, basal cell carcinoma, or other malignant tumors within 5 cm of the actinic keratosis lesions.\n* Participants with other skin diseases or skin conditions that, in the investigator's judgment, may interfere with the evaluation of safety or efficacy.\n* Participants who are unable to discontinue immunomodulators, immunosuppressants, cytotoxic agents, or corticosteroids from 1 month prior to signing the informed consent form until study completion or early withdrawal.\n* Participants who have undergone major surgery within 3 months prior to screening, or who plan to undergo surgery during the trial, as determined by the investigator.\n* Participants who have participated in any investigational drug clinical trial and received an investigational product within 3 months prior to screening.",{"count":108,"type":19},80,[110],"PHASE2","This is a multicenter, randomized, open-label, parallel-group, Phase II clinical trial designed to evaluate the efficacy and safety of HW211026 in adult patients with actinic keratosis.",[26],"2026-03-31",{"date":115,"type":37},"2026-04-07",{"date":117,"type":19},"2026-05",{"date":119,"type":19},"2027-12",{"name":121,"class":78},"Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":20,"phases":131,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100575911","phase-2-the-effect-of-topical-imipramine-on-photodynamic-therapy-mediated-immunosuppression-on-forearms-or-face-on-us-veterans-100575911","NCT06778434","The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans","Acid Sphingomyelinase Inhibition to Mitigate the Environmental Exposure Risks of Ultraviolet Light-Induced Actinic Neoplasia and Squamous Cell Carcinoma in US Veterans","Inclusion Criteria:\n\n* Adult Males and Females ages 18 and older who are patients at the Dayton VAMC Dermatology clinics\n* Skin type must be \"Fair\", Fitzpatrick type I or II, due to the presence of actinic damage in this population.\n* Subjects must have a VA physician's order to receive PDT treatment on their forearms.\n* Willing to participate and understand the informed consent document.\n* Willing to avoid excess sun exposure\u002Ftanning beds to the area to be treated with PDT.\n* Has stable transportation to attend study visits at DVA\n\nExclusion Criteria:\n\n* Currently taking any tricyclic antidepressants (TCAs)\n* Currently taking any selective serotonin reuptake inhibitor (SSRI)\n* Has Porphyria\n* Large tattoos in areas to be tested\n* Pregnancy or nursing\n* Taking any oral or topical medications that could interfere with the PDT\n* Active rashes in the areas",{"count":130,"type":19},48,[110],"The purpose of this study is to test the use of topical imipramine in combination with topical photodynamic therapy's (PDT) effect on the effectiveness and pain immunosuppression following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis or \"AK\") on their skin. These are both FDA-approved medications, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using mice that suggest imipramine might reduce immune system suppression by PDT thus allowing it to work better. Subjects whose provider has decided that they may benefit from PDT to treat their skin due to many AK precancerous lesions will be recruited for this study. Please note that the PDT itself is not experimental, only the imipramine treatment to the skin. There is a separate informed consent for the PDT.",[26,134,135],"Imipramine","Photodynamic Therapy","2025-12-18",{"date":138,"type":37},"2025-12-22",{"date":140,"type":37},"2025-04-01",{"date":142,"type":19},"2029-03-30",{"name":43,"class":44},1,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":15,"minAge":53,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":20,"phases":154,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":144},"100492189","phase-1-the-effect-of-topical-imipramine-on-pain-and-effectiveness-of-topical-photodynamic-therapy-100492189","NCT05688904","The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy","Pilot Studies Testing the Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy","Inclusion Criteria:\n\n* Male or female ages 18 and older\n* Skin type must be \"Fair\", Fitzpatrick type I to III, due to the presence of actinic damage in this population.\n* Subjects need to have a physician's order to receive PDT treatment on their face, scalp or forearms.\n* Willing to participate and understand the informed consent document.\n* Willing to avoid excess sun exposure\u002Ftanning beds to the area to be treated with PDT.\n\nExclusion Criteria:\n\n* Those currently taking any tricyclic antidepressants (TCAs)\n* Those currently taking any selective serotonin reuptake inhibitor (SSRI)\n* Those with porphyria\n* Large tattoos in the treated areas\n* Pregnancy or nursing\n* Taking any oral or topical medications that could interfere with the PDT (Appendix A)\n* Active rashes in the area",{"count":153,"type":19},24,[155],"PHASE1","The purpose of this study is testing the use of topical Imipramine in combination with topical photodynamic therapy's (PDT) effect on pain following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis-AKs) on their skin. These are both FDA-approved treatments, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using animals that suggest that imipramine might make the PDT less painful and might help it work better. In order to participate, the subject and their dermatologist have decided that they would benefit from PDT to treat their skin due to many AK precancerous lesions. Please note that neither PDT nor imipramine are experimental treatments, but treating their skin with imipramine before PDT is a new approach.",[134,135,26],"2024-04-23",{"date":160,"type":37},"2024-04-24",{"date":162,"type":37},"2023-01-19",{"date":164,"type":19},"2028-03",{"name":166,"class":167},"Wright State University","OTHER"]