Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-02-25 @ 6:51 PM
Study NCT ID:
NCT02219633
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2014-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2014-08-13', 'studyFirstSubmitQcDate': '2014-08-15', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total sign score at end of treatment', 'timeFrame': '22 days', 'description': 'Total Sign Score is defined as the sum of severity scores (4-point scale) of the Individual Sign Scores(erythema, edema/papulation, oozing/crusting, excoriations, lichenification and dryness)for each assessed area.'}], 'secondaryOutcomes': [{'measure': 'Total sign score on limited treatment area', 'timeFrame': '22 days'}, {'measure': "Investigator's treatment area assessment of disease severity", 'timeFrame': '22 days'}, {'measure': 'Subject´s treatment area assessment of disease severity', 'timeFrame': '22 days'}, {'measure': 'Subject´s assessment of itching', 'timeFrame': '22 days'}, {'measure': 'Transepidermal Water Loss', 'timeFrame': '22 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.leopharmatrials.com/en', 'label': 'Clinical Trials at LEO Pharma'}]}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to assess the efficacy of LEO 39652 cream compared with LEO 39652 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3)\n* Two symmetrical and comparable Entire Treatment Areas, on the same body region (left and right part)\n* Subjects must be in good health\n* Female subjects of childbearing potential and male subjects must be willing to consent to using high effective methods of contraception\n\nExclusion Criteria:\n\n* Any condition in the treatment areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash (other than atopic dermatitis), sunburn, hyper-or hypopigmentation, scars\n* Dark-skinned persons (i.e. skin type IV to VI according to Fitzpatrick classification system) whose skin colour prevents reliable clinical assessments\n* Any permanent (or transient within 28 days prior to dosing) disease (in particular cardiac disease such as heart failure or history of myocardial infarction) that may interfere with the subjects safe participation in the trial, with the subjects ability to participate in the trial or with the clinical assessments\n* Subjects with congenital or acquired immunodeficiencies or in subjects on therapy that causes immunosuppression'}, 'identificationModule': {'nctId': 'NCT02219633', 'briefTitle': 'Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'An Explorative Trial Evaluating the Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)', 'orgStudyIdInfo': {'id': 'LP0083-1085'}, 'secondaryIdInfos': [{'id': '2014-000849-80', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LEO 39652 cream', 'description': 'Topical application', 'interventionNames': ['Drug: LEO 39652 cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'LEO 39652 cream vehicle', 'description': 'Topical application', 'interventionNames': ['Drug: LEO 39652 cream']}], 'interventions': [{'name': 'LEO 39652 cream', 'type': 'DRUG', 'description': 'Applied for 21 days', 'armGroupLabels': ['LEO 39652 cream', 'LEO 39652 cream vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48159', 'city': 'Münster', 'country': 'Germany', 'facility': 'proinnovera GmbH, Center of Dermatology Excellence', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Lydia Graßhoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Proinnovera GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}