[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100445314":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":42,"centralContacts":42,"locations":43,"responsibleParty":110,"collaborators":112,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":42,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":42,"enrollmentInfo":125,"targetDuration":42,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":42,"overallStatus":134,"whyStopped":42,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Encube Ethicals Pvt. Ltd.","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Comparator Arm","ACTIVE_COMPARATOR","Reference Product (B): Fluorouracil 5% Topical Cream of Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.",[13],"Drug: Reference Product (B): Fluorouracil 5% Topical Cream of Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.",{"label":15,"type":16,"description":17,"interventionNames":18},"Arms and Interventions","EXPERIMENTAL","Test Product (A): Fluorouracil Cream, 5% of Encube Ethicals Pvt. Ltd., India",[19],"Drug: Test Product (A): Fluorouracil Cream, 5% topical cream",{"label":21,"type":22,"description":23,"interventionNames":24},"Placebo Arm","PLACEBO_COMPARATOR","Placebo Product (C): Test vehicle cream for fluorouracil 5% of Encube Ethicals Pvt. Ltd., India",[25],"Drug: Placebo Product (C): Test vehicle cream for fluorouracil 5% of Encube Ethicals Pvt. Ltd., India",[27,34,38],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Test Product (A): Fluorouracil Cream, 5% topical cream","Apply cream twice daily in an amount sufficient to cover the lesions. Fluorouracil should be applied preferably with a nonmetal applicator or suitable glove. If Fluorouracil is applied with the fingers, the hands should be washed immediately afterward.",[15],[33],"Experimental",{"type":28,"name":11,"description":30,"armGroupLabels":35,"otherNames":36},[9],[37],"Active Comparator",{"type":28,"name":23,"description":30,"armGroupLabels":39,"otherNames":40},[21],[41],"Placebo Comparator",null,[44,57,66,76,85,91,100],{"facility":45,"status":42,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":42},"CBCC Global Research Site 005","Bakersfield","California","93309","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-119.01871,35.37329,{"lat":55,"lon":54},{"facility":58,"status":42,"city":59,"state":47,"zip":60,"country":49,"countryCode":50,"cosmosGeoPoint":61,"geoPoint":65,"contacts":42},"CBCC Global Research Site 006","Cerritos","90703",{"type":52,"coordinates":62},[63,64],-118.06479,33.85835,{"lat":64,"lon":63},{"facility":67,"status":42,"city":68,"state":69,"zip":70,"country":49,"countryCode":50,"cosmosGeoPoint":71,"geoPoint":75,"contacts":42},"CBCC Global Research Site 004","Lauderdale Lakes","Florida","33308",{"type":52,"coordinates":72},[73,74],-80.20838,26.16647,{"lat":74,"lon":73},{"facility":77,"status":42,"city":78,"state":69,"zip":79,"country":49,"countryCode":50,"cosmosGeoPoint":80,"geoPoint":84,"contacts":42},"CBCC Global Research Site 001","Miami","33015",{"type":52,"coordinates":81},[82,83],-80.19366,25.77427,{"lat":83,"lon":82},{"facility":86,"status":42,"city":78,"state":69,"zip":87,"country":49,"countryCode":50,"cosmosGeoPoint":88,"geoPoint":90,"contacts":42},"CBCC Global Research Site 002","33175",{"type":52,"coordinates":89},[82,83],{"lat":83,"lon":82},{"facility":92,"status":42,"city":93,"state":69,"zip":94,"country":49,"countryCode":50,"cosmosGeoPoint":95,"geoPoint":99,"contacts":42},"CBCC Global Research Site 003","Miramar","33027",{"type":52,"coordinates":96},[97,98],-80.23227,25.98731,{"lat":98,"lon":97},{"facility":101,"status":42,"city":102,"state":103,"zip":104,"country":49,"countryCode":50,"cosmosGeoPoint":105,"geoPoint":109,"contacts":42},"CBCC Global Research Site 007","Sugarloaf","Pennsylvania","18249",{"type":52,"coordinates":106},[107,108],-76.12083,41.98343,{"lat":108,"lon":107},{"type":111,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[113],{"name":114,"class":115},"CBCC Global Research","NETWORK","100445314","phase-3-therapeutic-equivalence-of-fluorouracil-cream-5-compared-with-fluorouracil-5-topical-cream-of-mylanpharmaceuticals-inc-usa-in-the-treatment-of-actinic-keratosis-100445314",false,"NCT05078827","Therapeutic Equivalence of Fluorouracil Cream, 5% Compared With Fluorouracil 5% Topical Cream of MylanPharmaceuticals Inc., U.S.A in the Treatment of Actinic Keratosis","A Randomized, Double-blind, Multi-center, Three-arm, Parallel-group, Multiple-dose, Placebo Controlled Study to Assess the Therapeutic Equivalence of Fluorouracil Cream USP 5% of Encube Ethicals Pvt. Ltd., India Compared With Fluorouracil 5% Topical Cream of Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. in the Treatment of Actinic Keratosis","Inclusion Criteria:\n\n* Willing and able to provide voluntary informed consent and follow the protocol requirements\n* Males or females at least 18 years of age\n* Subjects with at least five (5) and no more than ten (10) clinically typical, visible, discrete, AK lesions, each at least 4 mm in diameter on the face or bald scalp. In this interpretation, if the total number of lesions on the face and bald scalp exceeds 10 and there are either 5-10 lesions on the face or 5-10 lesions on the bald scalp then select the designated treatment area that has 5-10 lesions (i.e., face or bald scalp)\n* Skin pigmentation (Fitzpatrick skin type I, II, and III) that will allow differentiation of erythema assessment\n* Females of childbearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU\u002FmL or equivalent units of human chorionic gonadotropin)\n* Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, intrauterine device, a double barrier method, oral, transdermal, injected, or implanted nonhormonal or hormonal contraceptive) throughout the study. Female patients using hormonal contraceptives should have been on the same product\u002Fdosing regimen for at least 28 days before Visit 1 and should not change this regimen during the study. A sterile sexual partner is not considered an adequate form of birth control.\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to Fluorouracil or any of the excipients in the Test, Reference or Placebo products\n* Presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, or other possible confounding skin conditions on the face or bald scalp\n* Use within 6 months before Visit 1 on the face or bald scalp of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) ultraviolet B therapy\n* Use within 1 month before Visit 1 on the face or scalp of 1) cryo destruction or chemo destruction, 2) curettage, 3) photodynamic therapy, 4) surgical excision, 5) topical 5-fluorouracil, 6) topical corticosteroids 7) topical diclofenac, 8) topical imiquimod, 9) topical retinoids, or 10) other treatments for AK including glycolic acid or over-the-counter products containing retinol, alpha or beta hydroxy acids\n* Use within 1 month before Visit 1 of 1) immunomodulators or immunosuppressive therapies, 2) interferon, 3) oral or injectable corticosteroids, or 4) cytotoxic drugs\n* Known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency\n* Inability to understand the requirements of the study and the relative information or are unable or not willing to comply with the study protocol\n* Employees of the Investigator or research center or their immediate family members\n* Patients who have participated in this study previously\n* Patient lived in the same household as currently enrolled subject","ALL","18 Years",{"count":126,"type":127},458,"ACTUAL","INTERVENTIONAL",[130],"PHASE3","Fluorouracil is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites.",[133],"Actinic Keratoses","COMPLETED","2023-03-10",{"date":137,"type":127},"2023-03-14",{"date":139,"type":127},"2022-03-01",{"date":141,"type":127},"2022-12-01",{"name":5,"class":6},7]