[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06778434":3,"trial-entities:NCT06778434":126,"trial-summary:NCT06778434":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":54,"sex":69,"minimum_age":70,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":71,"std_ages":88,"locations":91,"central_contacts":114,"overall_officials":122,"references":124,"see_also_links":125},"NCT06778434","ONCE-001-24S","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","RECRUITING","2029-03-30","2025-12","2025-12-22","2025-04-01","VA Office of Research and Development","FED",false,"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.",null,[19,20,21],"Actinic Keratosis","Imipramine","Photodynamic Therapy",[],"INTERVENTIONAL","BASIC_SCIENCE",[26],"PHASE2",{"count":28,"type":29},48,"ESTIMATED",[31,37],{"type":32,"name":20,"description":33,"armGroupLabels":34},"DRUG","10% imipramine",[35,36],"Imipramine and Control Vehicle on Face","Imipramine and Control Vehicle on Forearms",{"type":38,"name":39,"description":40,"armGroupLabels":41},"OTHER","Control Vehicle","polyethylene glycol: dimethyl sulfoxide Solution",[35,36],[43,47,50],{"measure":44,"description":45,"timeFrame":46},"(Forearm Arm Only): Difference in areas of Candida antigen skin test results with PDT+ imipramine","Size of skin reactions from baseline values will be obtained following PDT + vehicle\u002Fimipramine using calipers.","7, 30, 90 days post-PDT treatments",{"measure":48,"description":49,"timeFrame":46},"(Forearm Arm Only): Difference in redness of Candida antigen skin test results with PDT+ imipramine","Redness of skin reactions from baseline values will be obtained following PDT + vehicle\u002Fimipramine using mexameter device and thermal imaging.",{"measure":51,"description":52,"timeFrame":53},"Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the face","Differences in baseline values of AK will be obtained following PDT + vehicle\u002Fimipramine by counting and mapping on each side of face\u002Fscalp.","6, 12 months post-PDT treatment",[55,58,62,66],{"measure":56,"description":57,"timeFrame":53},"Difference in numbers of precancerous AK skin lesions with PDT and imipramine on the forearms","Differences in baseline values of AK will be obtained following PDT + vehicle\u002Fimipramine by counting and mapping each forearm\u002Fwrist.",{"measure":59,"description":60,"timeFrame":61},"(Forearm Arm Only): Difference in gene profile of skin following treatment with PDT + imipramine","Differences in transcriptome RNA values from baseline will be obtained following PDT + vehicle\u002Fimpramine by use of tissue RNA-seq with a commercial dermal transcriptomal patch.","7 days post-PDT treatment",{"measure":63,"description":64,"timeFrame":65},"Differences in post-PDT redness with PDT + imipramine","Differences in redness following PDT + imipramine vs PDT + vehicle from baseline values will be obtained using a mexameter device and thermal imaging on face\u002Fforearms.","10 min, 30 min, 24 hours post-PDT treatments",{"measure":67,"description":68,"timeFrame":65},"Differences in post-PDT pain with PDT + imipramine","Differences in pain following PDT + imipramine vs PDT + vehicle from baseline values will be obtained using a visual analog scale on face\u002Fforearms.","ALL","18 Years",{"inclusion":72,"exclusion":79,"raw_text":87},[73,74,75,76,77,78],"Adult Males and Females ages 18 and older who are patients at the Dayton VAMC Dermatology clinics","Skin type must be \"Fair\", Fitzpatrick type I or II, due to the presence of actinic damage in this population.","Subjects must have a VA physician's order to receive PDT treatment on their forearms.","Willing to participate and understand the informed consent document.","Willing to avoid excess sun exposure\u002Ftanning beds to the area to be treated with PDT.","Has stable transportation to attend study visits at DVA",[80,81,82,83,84,85,86],"Currently taking any tricyclic antidepressants (TCAs)","Currently taking any selective serotonin reuptake inhibitor (SSRI)","Has Porphyria","Large tattoos in areas to be tested","Pregnancy or nursing","Taking any oral or topical medications that could interfere with the PDT","Active rashes in the areas","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",[89,90],"ADULT","OLDER_ADULT",[92],{"facility":93,"status":8,"city":94,"state":95,"zip":96,"country":97,"contacts":98,"geoPoint":111},"Dayton VA Medical Center, Dayton, OH","Dayton","Ohio","45428","United States",[99,104,108],{"name":100,"role":101,"phone":102,"email":103},"Elizabeth Cates, MPA","CONTACT","(937) 245-7500","elizabeth.cates@wrightstatephysicians.org",{"name":105,"role":101,"phone":106,"email":107},"Christina B Knisely, MPH","(937) 724-7500","Christina.knisely@wright.edu",{"name":109,"role":110},"Jeffrey Travers, MD","PRINCIPAL_INVESTIGATOR",{"lat":112,"lon":113},39.75895,-84.19161,[115,118],{"name":116,"role":101,"phone":102,"email":117},"Craig A Rohan, MD","craig.rohan@va.gov",{"name":109,"role":101,"phone":119,"phoneExt":120,"email":121},"(937) 268-6511","2026","Jeffrey.Travers@va.gov",[123],{"name":109,"affiliation":93,"role":110},[],[],{"nct_id":4,"conditions":127,"biomarkers":128},[19],[],{"nct_id":4,"found":130,"summary":131,"prompt_version":141},true,{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This is an interventional study. It plans to enroll 48 participants.","completed","Topical Imipramine with Photodynamic Therapy for Actinic Keratosis","This study is looking at how a cream called imipramine, when used with photodynamic therapy (PDT), affects the treatment of actinic keratosis (AK), which are precancerous skin lesions. PDT is a common treatment for AK, and imipramine is an FDA-approved medication. Researchers want to see if combining them can make PDT more effective by reducing its impact on your immune system. You may be able to join if you are an adult veteran (18 or older) with fair skin (Fitzpatrick type I or II) who has many AKs and a VA doctor has ordered PDT for your forearms. The study will measure differences in skin test results and the number of AK lesions on your face after treatment. The current status of this study is unclear, and it plans to enroll 48 participants.","For forearm treatments, you would be followed for 7, 30, and 90 days after PDT. For face treatments, you would be followed for 6 and 12 months after PDT.",133,"Not specified in the trial record.","Not stated in the trial record.",[20],"v2"]