[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06461442":3,"trial-entities:NCT06461442":115,"trial-summary:NCT06461442":119},{"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":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":47,"sex":69,"minimum_age":70,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":71,"std_ages":90,"locations":93,"central_contacts":103,"overall_officials":104,"references":109,"see_also_links":114},"NCT06461442","2164169","Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis","Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis: A Prospective, Randomized Controlled, Intra-Individual Trial","ENROLLING_BY_INVITATION","2026-09-01","2026-07","2026-07-06","2024-07-01","University of California, Davis","OTHER",false,"The goal of this clinical trial is to compare the effectiveness and safety of two treatments-cryotherapy and 5-Fluorouracil (5-FU)-for actinic keratosis, a common skin condition caused by long-term sun exposure. Cryotherapy is a treatment that uses extreme cold produced by liquid nitrogen to freeze and destroy abnormal cells, and 5-FU is a topical cream applied to the skin to treat lesions by interfering with cell growth. The main questions this trial aims to answer are:\n\n* Which treatment, cryotherapy or 5-FU, is more effective in reducing the number of actinic keratosis lesions?\n* What are the side effects associated with each treatment?\n* How do these treatments impact patient satisfaction, cosmetic outcomes, and health-related quality of life?\n\nParticipants will:\n\n* Undergo a baseline assessment where their demographics information such as age, sex, race, smoking status, and medical history are recorded, along with the number and severity of actinic keratosis lesions.\n* Receive both cryotherapy and 5-FU, with each treatment applied to different areas of their body. The area of the body to receive each treatment is decided by a random process (like flipping a coin).\n* Complete weekly surveys to monitor for side effects during and after the treatment period.\n* Return to the clinic for follow-up assessments at 3 months and 12 months.",null,[19],"Actinic Keratoses",[21,22],"cryotherapy","5-Fluorouracil","INTERVENTIONAL","TREATMENT",[26],"PHASE4",{"count":28,"type":29},73,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"PROCEDURE","Cryotherapy","Extremely cold liquid (liquid nitrogen) will used by a dermatologist to freeze and destroy abnormal cells in the treatment areas randomized to this treatment.",[36],"Cryotherapy and 5-Fluoruracil",{"type":38,"name":39,"description":40,"armGroupLabels":41},"DRUG","5Fluorouracil","Patients will apply 5% 5-Fluorouracil cream in a thin layer twice daily for 4 weeks on the treatment areas randomized to this treatment.",[36],[43],{"measure":44,"description":45,"timeFrame":46},"Partial clearance rate","Proportion of patients with at least a 75% reduction in the number of baseline AK lesions within the selected treatment area","3 months and 12 months",[48,51,54,57,60,63,66],{"measure":49,"description":50,"timeFrame":46},"Complete clearance rate","Proportion of patients with no clinically visible AK lesions (i.e., a 100% reduction in the number of baseline AK lesions) within the selected treatment area",{"measure":52,"description":53,"timeFrame":46},"Percent reduction of AK lesions","Decrease in number AK lesions from baseline within the selected treatment area",{"measure":55,"description":56,"timeFrame":46},"Rate of progression to keratinocyte carcinoma","Proportion of AK lesions within the treatment area that progress to keratinocyte carcinoma",{"measure":58,"description":59,"timeFrame":46},"Recurrence rate","Proportion of participants with recurrent or new lesions within the treatment area",{"measure":61,"description":62,"timeFrame":46},"Patient satisfaction","Proportion of patients who would choose the same treatment again and if they would recommend it to others",{"measure":64,"description":65,"timeFrame":46},"Health-Related Quality of Life","Skindex-29 questionnaire",{"measure":67,"description":68,"timeFrame":46},"Cosmetic outcome","The cosmetic outcome will be evaluated using a 4-point scale (1 = excellent, 2 = good, 3 = moderate, and 4 = poor) by an investigator who is blinded to the treatment allocation","ALL","18 Years",{"inclusion":72,"exclusion":77,"raw_text":89},[73,74,75,76],"18 years of age or older","Has a clinical diagnosis of 10 or more AKs in the head, neck, or extremities areas","Able to give informed consent themselves","Willing to return for follow up visits",[78,79,80,81,82,83,84,85,86,87,88],"Cognitively Impaired","Incarcerated","Non-English speakers","Immuno-comprised status","Received any kind of treatment for AK within the past 2 months","Use of systemic retinoids within the past 3 months","Suspicion of cancer in the target area","Porphyria","Genetic skin cancer disorders","Allergy to trial drugs or peanut\u002Fsoy products","Pregnancy or breast-feeding","Inclusion Criteria:\n\n* 18 years of age or older\n* Has a clinical diagnosis of 10 or more AKs in the head, neck, or extremities areas\n* Able to give informed consent themselves\n* Willing to return for follow up visits\n\nExclusion Criteria:\n\n* Cognitively Impaired\n* Incarcerated\n* Non-English speakers\n* Immuno-comprised status\n* Received any kind of treatment for AK within the past 2 months\n* Use of systemic retinoids within the past 3 months\n* Suspicion of cancer in the target area\n* Porphyria\n* Genetic skin cancer disorders\n* Allergy to trial drugs or peanut\u002Fsoy products\n* Pregnancy or breast-feeding",[91,92],"ADULT","OLDER_ADULT",[94],{"facility":95,"city":96,"state":97,"zip":98,"country":99,"geoPoint":100},"University of California, Davis - Dermatology Department","Sacramento","California","95816","United States",{"lat":101,"lon":102},38.58157,-121.4944,[],[105],{"name":106,"affiliation":107,"role":108},"Daniel Eisen, MD","UC Davis Department of Dermatology","PRINCIPAL_INVESTIGATOR",[110],{"pmid":111,"type":112,"citation":113},"30855743","BACKGROUND","Jansen MHE, Kessels JPHM, Nelemans PJ, Kouloubis N, Arits AHMM, van Pelt HPA, Quaedvlieg PJF, Essers BAB, Steijlen PM, Kelleners-Smeets NWJ, Mosterd K. Randomized Trial of Four Treatment Approaches for Actinic Keratosis. N Engl J Med. 2019 Mar 7;380(10):935-946. doi: 10.1056\u002FNEJMoa1811850.",[],{"nct_id":4,"conditions":116,"biomarkers":118},[117],"Actinic Keratosis",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]