Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT06274320
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2024-02-16', 'studyFirstSubmitQcDate': '2024-02-16', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in lesion response rate', 'timeFrame': 'from baseline to Day70', 'description': 'It is defined as the number of completely responding lesions divided by the total number of treated lesions in each field. Complete lesion response is defined as complete disappearance of the lesion both by palpation and visual.'}], 'secondaryOutcomes': [{'measure': 'Percentage change', 'timeFrame': 'from baseline to Day70', 'description': 'The lesion complete response rate is defined as the percentage of pre-existing and treated lesions at Baseline that are assessed as clear (complete disappearance of the lesion, visually and by palpation).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['actinic keratoses', 'Lipikar Urea 30%', 'Olsen grade'], 'conditions': ['Actinic Keratoses']}, 'descriptionModule': {'briefSummary': 'This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment.', 'detailedDescription': 'Actinic keratoses (AK) are chronic skin changes usually induced by UV radiation. There are numerous options to treat AK. Some of the most used field-directed therapies include topical therapy with 5-fluorouracil (5-FU) cream and photodynamic therapy. However, the treatment with 5-FU is not without side effects (erythema, pruritus, itching/burning, etc.). Therefore, in daily clinical practice, cosmetic pre- and concomitant applications of cosmetics are often recommended to increase the efficacy as well as the tolerability of Tolak®.\n\nThe aim of this randomized, evaluator blinded, controlled parallel group study conducted in compliance with the 2013 version of the Declaration of Helsinki is to determine whether and how the application of cosmetics leads to an influence on the microbiome of AK.\n\nStatistical method: The variables will be analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. Each test will be two-sided, at the 0.050 significance level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of at least 4 non-hypertrophic, non-hyperkeratotic actinic keratosis of the the scalp\n* planned treatment of actinic keratoses of the scalp with Tolak®\n* Olsen grade I or II\n\nExclusion Criteria:\n\n* known or documented intolerance to any of the ingredients of Tolak® or Lipikar Urea 30%\n* treatment of actinic keratoses in the treatment area within the past 3 months (e.g. photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy etc.)\n* suspected invasive squamous cell cancer in the treatment area\n* chronic wounds, erosions, pre-existing inflamed or infected skin with disruption of the epidermal barrier in the treatment area current or within the last 8 weeks given systemic cancer medication or systemic treatment with 5-Fluorouracil'}, 'identificationModule': {'nctId': 'NCT06274320', 'briefTitle': 'Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cosmetique Active International'}, 'officialTitle': 'Investigation of the Effect of a 2 Weeks Lipikar Urea 30% Application Preceding a Planned Topical 5-FU 4% Actinic Keratoses Treatment on Efficacy of 5-FU 4%', 'orgStudyIdInfo': {'id': 'LRP22002 LIPIKAR UREA 30%'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: holistic approach', 'description': 'adult subjects having AK (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria including a Tolak® treatment planned before study start', 'interventionNames': ['Other: Group A: holistic approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: Tolak® Standard of use', 'description': 'adult subjects having AK (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria including a Tolak® treatment planned before study start', 'interventionNames': ['Other: Group B: Tolak® Standard of use']}], 'interventions': [{'name': 'Group A: holistic approach', 'type': 'OTHER', 'description': '2-week Lipikar Urea 30% application (once daily in the evening) + 4-week Tolak® treatment (once daily in the evening)', 'armGroupLabels': ['Group A: holistic approach']}, {'name': 'Group B: Tolak® Standard of use', 'type': 'OTHER', 'description': '4-week Tolak® alone treatment (once daily in the evening)', 'armGroupLabels': ['Group B: Tolak® Standard of use']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuppertal', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'CentroDerm GmbH', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}], 'centralContacts': [{'name': 'Thomas Dirschka', 'role': 'CONTACT', 'email': 's.weber@centroderm.de', 'phone': '+49 2 02 / 629337-32'}], 'overallOfficials': [{'name': 'Thomas Dirschka', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CentroDerm GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cosmetique Active International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}