Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-04-22 @ 2:53 PM
Study NCT ID:
NCT02289768
Status:
COMPLETED
Last Update Posted:
2016-08-05
First Post:
2014-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In Patients With Grade I-II Actinic Keratoses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629092', 'term': '5-fluorouracil, salicylic acid drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-03', 'studyFirstSubmitDate': '2014-11-10', 'studyFirstSubmitQcDate': '2014-11-10', 'lastUpdatePostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with complete clinical clearance of actinic keratosis lesions in the treatment field', 'timeFrame': 'Week 20', 'description': 'Complete Clinical Clearance is defined as no clinically visible actinic keratosis lesions in the selected treatment area'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with partial clinical clearance of actinic keratosis lesions in the treatment field', 'timeFrame': 'Week 20', 'description': 'Partial clearance is defined as a 75% or greater reduction in the number of clinically visible actinic keratosis lesions in the selected treatment area'}, {'measure': 'Percentage change from baseline in the total number of actinic keratosis lesions', 'timeFrame': 'Week 20'}, {'measure': 'Global assessment of efficacy by the physician (Physician Global Assessment)', 'timeFrame': 'Week 20'}, {'measure': 'Change from baseline in total score of the Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Week 20'}, {'measure': 'Total score of the patients´ treatment satisfaction questionnaire for medication (TSQM)', 'timeFrame': 'Week 20'}, {'measure': 'Percentage of patients with complete clearance of three pre-defined subclinical actinic keratosis lesions', 'timeFrame': 'Week 20', 'description': 'Sub-clinical lesions will be determined using reflectance confocal microscopy in a subset of 30 patients'}, {'measure': 'Percentage change from baseline in the three selected actinic keratosis subclinical lesions', 'timeFrame': 'Week 20', 'description': 'Sub-clinical lesions will be determined using reflectance confocal microscopy in a subset of 30 patients'}, {'measure': 'Percentage of patients for which the clearance of one pre-defined representative clinical actinic keratosis lesion is confirmed by reflectance confocal microscopy', 'timeFrame': 'Week 20', 'description': 'Determined using reflectance confocal microscopy in a subset of 30 patients'}, {'measure': 'The number of patients with adverse events', 'timeFrame': 'Week 20'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Actinic Keratosis']}, 'referencesModule': {'references': [{'pmid': '27995485', 'type': 'DERIVED', 'citation': 'Stockfleth E, von Kiedrowski R, Dominicus R, Ryan J, Ellery A, Falques M, Ivanoff N, Azeredo RR. Efficacy and Safety of 5-Fluorouracil 0.5%/Salicylic Acid 10% in the Field-Directed Treatment of Actinic Keratosis: A Phase III, Randomized, Double-Blind, Vehicle-Controlled Trial. Dermatol Ther (Heidelb). 2017 Mar;7(1):81-96. doi: 10.1007/s13555-016-0161-2. Epub 2016 Dec 19.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this vehicle-controlled study is to determine the efficacy and safety of a solution of Actikerall® (containing 5-fluorouracil 0.5% and salicylic acid 10.0%) in the field-directed treatment of grade I-II actinic keratosis, when it is applied to the affected area once daily for 12 weeks.\n\nA secondary objective of this study is to evaluate the efficacy of Actikerall® solution on subclinical actinic keratosis lesions in a subset of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or non-pregnant, non-lactating (in the last 3 months) female aged between 18 and 85 years (both inclusive). Women of childbearing potential will follow specific study requirements.\n* Patients with at least 4 but not more than 10 clinically confirmed actinic keratoses lesions grade I or II (according to Olsen EA et al. 1991) within a field of cancerization of 25 cm² in the face/forehead or bald scalp.\n* Patients with skin type I to IV (according to Fitzpatrick Skin Types)\n* Patients free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that may interfere with area examination or final evaluation.\n* Patients in good health condition or free of medical conditions that may interfere with the study results as confirmed by a physical examination, medical history and laboratory analysis.\n* Patients who accept to refrain from sunbathing, intense UV-light exposure and the solarium during the study duration.\n* Patients willing to stop using moisturizers and topical treatments with anti-aging products, vitamins A, C, and/or E containing ointments and gels and green tea preparations in the treatment area.\n* Patients able (physical ability or supportive person) to apply the study preparations correctly and to follow the study procedure and restrictions.\n* Patients with at least 3 subclinical lesions in the 25 cm² test area (field) clearly separated from each other and the actinic keratoses lesions (additional inclusion criteria for the patients participating on the sub-clinical lesions sub-study).\n\nExclusion Criteria:\n\n* Subjects that have received treatment for actinic keratoses within the treatment area in the 3 months previous to Visit 1 (screening).\n* Subjects that have received prohibited pharmacological or non-pharmacological treatments for any indication other than actinic keratoses within the treatment area before randomization (Visit 2).\n* Subjects that have received prohibited systemic treatments for any indication before randomization (Visit 2).\n* Subjects taking phenytoin, methotrexate or sulfonylurea.\n* Subjects with dermatological diseases in the treatment area or surrounding area that may be exacerbated by the study treatment or may interfere the study assessments (e.g. psoriasis, eczema).\n* Subjects that have currently malignant or benign tumors of the skin within the treatment area (e.g., malignant melanoma, basal cell carcinoma, squamous cell carcinoma).\n* Subjects that suffer from any kind of photodermatoses.\n* Subjects that have evidence of clinically significant unstable medical conditions.\n* Subjects with known hypersensitivity to any of the trial drugs (5-fluorouracil, salicylic acid), to ingredients of the trial formulation, or to drugs of similar chemical classes\n* Subjects with allergy against dimethylsulfoxide, ethanol, ethyl acetate, pyroxyline, poly(butyl)methacrylate, and/or methylmethacrylate.\n* Subjects with dihydropyrimidine dehydrogenase deficiency (DPD deficiency).\n* Subjects that are currently participating or have participated within the 8 weeks prior to Visit 1 in another clinical trial.\n* Patients with known drug or alcohol abuse as assessed by the investigator within the 2 years prior to Visit 1.\n* Subject is institutionalized because of legal or regulatory order.'}, 'identificationModule': {'nctId': 'NCT02289768', 'briefTitle': 'Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In Patients With Grade I-II Actinic Keratoses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Almirall, S.A.'}, 'officialTitle': 'Multicentre, Randomized, Parallel, Double-Blind, Vehicle Controlled Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In The Field-Directed Treatment Of Actinic Keratoses Grade I To II (Field Cancerization)', 'orgStudyIdInfo': {'id': '98605101-1401'}, 'secondaryIdInfos': [{'id': '2014-001171-31', 'type': 'EUDRACT_NUMBER'}, {'id': 'ALM014', 'type': 'OTHER', 'domain': 'Almirall Hermal GmbH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5-fluorouracil/salicylic acid', 'description': 'Actikerall® solution (5-fluorouracil 0.5%, salicylic acid 10.0%) applied to the affected area once-daily for 12 weeks', 'interventionNames': ['Drug: 5-fluorouracil/salicylic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Vehicle solution applied to the affected area once-daily for 12 weeks', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': '5-fluorouracil/salicylic acid', 'type': 'DRUG', 'otherNames': ['Actikerall'], 'armGroupLabels': ['5-fluorouracil/salicylic acid']}, {'name': 'Vehicle', 'type': 'DRUG', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Almirall Investigational Site #3', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13055', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Almirall Investigational Site #5', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13507', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Almirall Investigational Site #4', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Almirall Investigational Site #1', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '44803', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Almirall Investigational Site #8', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '53111', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Almirall Investigational Site #6', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '48249', 'city': 'Dülmen', 'country': 'Germany', 'facility': 'Almirall Investigational Site #9', 'geoPoint': {'lat': 51.83149, 'lon': 7.28075}}, {'zip': '88045', 'city': 'Friedrichshafen', 'country': 'Germany', 'facility': 'Almirall Investigational Site #10', 'geoPoint': {'lat': 47.65689, 'lon': 9.47554}}, {'zip': '56242', 'city': 'Selters', 'country': 'Germany', 'facility': 'Almirall Investigational Site #2', 'geoPoint': {'lat': 50.51681, 'lon': 8.28953}}, {'zip': '42275', 'city': 'Wuppertal', 'country': 'Germany', 'facility': 'Almirall Investigational Site #7', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'zip': 'LE10 2SE', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Almirall Investigational Site #11', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'CW5 5NX', 'city': 'Nantwich', 'country': 'United Kingdom', 'facility': 'Almirall Investigational Site #12', 'geoPoint': {'lat': 53.06878, 'lon': -2.52051}}, {'zip': 'TR18 4JH', 'city': 'Penzance', 'country': 'United Kingdom', 'facility': 'Almirall Investigational Site #13', 'geoPoint': {'lat': 50.11861, 'lon': -5.53715}}, {'zip': 'TR19 7HX', 'city': 'Penzance', 'country': 'United Kingdom', 'facility': 'Almirall Investigational Site #14', 'geoPoint': {'lat': 50.11861, 'lon': -5.53715}}], 'overallOfficials': [{'name': 'Wolf-Godehard Ocker', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Almirall Hermal GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Almirall, S.A.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Almirall Hermal GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}