Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:42 PM
Study NCT ID:
NCT05740969
Status:
UNKNOWN
Last Update Posted:
2023-02-23
First Post:
2023-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gene and Protein Expression Profiles After Treatment of 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': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077271', 'term': 'Imiquimod'}, {'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gene and protein expression profiles', 'timeFrame': '10 days of treatment'}], 'secondaryOutcomes': [{'measure': 'histopathological assessment of actinic keratoses', 'timeFrame': '10 days of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Actinic Keratoses']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to investigate the effect of 5-fluorouracil, imiquimod, and melatonin for actinic keratosis on immunological gene, and protein expressions profiles. Secondarily, the aim is to assess the effect of the treatment on the histopathology of actinic keratoses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants should have a clinical diagnosis of actinic keratosis\n* Participants should be 18 years old or above\n* Participants must sign an informed consent\n\nExclusion Criteria:\n\n* Known allergic reaction to either 5-fluorouracil , imiquimod, or melatonin\n* Immunomodulating treatment\n* Predictable poor compliance (due to i.e. dementia, substance abuse, psychiatric disease, life-threatening disease or language barriers)\n* Pregnant or breastfeeding\n* Females not in menopause (defined as no menstruation during the last 12 months) should use a secure birth control (intrauterine devices, hormonal contraceptives including - oral pills, patches, vaginal rings and injections) during the entire period of the trial'}, 'identificationModule': {'nctId': 'NCT05740969', 'acronym': 'PACKS', 'briefTitle': 'Gene and Protein Expression Profiles After Treatment of Actinic Keratoses', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Gene and Protein Expression Profiles After Treatment of Actinic Keratoses', 'orgStudyIdInfo': {'id': 'REG-163-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '5-Fluorouracil', 'description': 'Patients will be asked apply a 40 mg/g creme containing 5-Fluorouracil once a day on their lesion for 10 days. A biopsy will be taken four days after last application. The patient will be refered to a dermatologist for further treatment, if necessary.', 'interventionNames': ['Drug: 5Fluorouracil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Imiquimod', 'description': 'Patients will be asked apply a 50 mg/g creme containing imiquimod thrice a week on their lesion for 10 days. A biopsy will be taken four days after last application. The patient will be refered to a dermatologist for further treatment, if necessary.', 'interventionNames': ['Drug: Imiquimod']}, {'type': 'EXPERIMENTAL', 'label': 'Melatonin', 'description': 'Patients will be asked apply a 25 mg/g creme containing melatonin once a day on their lesion for 10 days. A biopsy will be taken four days after last application. The patient will be refered to a dermatologist for further treatment, if necessary.', 'interventionNames': ['Drug: Melatonin']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'A biopsy will be taken from the patient and the patient will be refered to a dermatologist for further treatment, if necessary.'}], 'interventions': [{'name': '5Fluorouracil', 'type': 'DRUG', 'description': 'Cream', 'armGroupLabels': ['5-Fluorouracil']}, {'name': 'Imiquimod', 'type': 'DRUG', 'description': 'Cream', 'armGroupLabels': ['Imiquimod']}, {'name': 'Melatonin', 'type': 'DRUG', 'description': 'Cream', 'armGroupLabels': ['Melatonin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4600', 'city': 'Roskilde', 'state': 'Region Sjælland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jawad A Zahid, MD', 'role': 'CONTACT'}], 'facility': 'Zealand University Hospital', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}], 'centralContacts': [{'name': 'Jawad A Zahid, MD', 'role': 'CONTACT', 'email': 'jaza@regsj.dk', 'phone': '+4551329815'}], 'overallOfficials': [{'name': 'Ismail A. Gögenur, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center For Surgical Science, Dept. of Surgery, Zealand University Hosptial'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ismail Gögenur', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ismail Gögenur', 'investigatorAffiliation': 'Zealand University Hospital'}}}}