Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-25 @ 11:46 PM
Study NCT ID:
NCT01447758
Status:
TERMINATED
Last Update Posted:
2025-02-24
First Post:
2011-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592443', 'term': '2-(6-(2-(3,5-dichloro-4-pyridyl)acetyl)-2,3-dimethoxyphenoxy)-N-propylacetamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2011-07-13', 'studyFirstSubmitQcDate': '2011-10-04', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK profile - Cohort I, II, III', 'timeFrame': 'Predose, 1h, 2h, 4h, 6h, 12h, 13h, 14h, 16h, 18h, 24h (on day 1 and 7) and 36h, 48h, 72h (on day 7 only)', 'description': 'Cmax, AUC, Tmax'}, {'measure': 'Tolerability and safety of LEO 29102 cream - Cohort I, II, III', 'timeFrame': '14 Days', 'description': 'Number of subjects with AEs and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate body temperature), ECG parameters, clinical laboratory, physical examination'}, {'measure': 'PK profile - Cohort IV', 'timeFrame': 'Day 1, 14, 28, 42: Pre AM dose and 1h, 2h, 4h, 6h, 12h. Post AM dose, but prior to PM dose and 24 h, 36h, 48h, 72h after AM dose Day 42', 'description': 'Cmax, AUC, Tmax'}, {'measure': 'Tolerability and safety of LEO 29102 cream - Cohort IV', 'timeFrame': '49 Days', 'description': 'Number of subjects with AEs and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate body temperature), ECG parameters, clinical laboratory, physical examination, SCORAD, EASI and IGA by stratum, treatment and visit.'}], 'secondaryOutcomes': [{'measure': 'Dermis concentration of LEO 29102 and its metabolites LEO 28386 and LEO 26989 after multiple topical applications in subjects with AD (Cohorts II and IV, Subgroup 1)', 'timeFrame': '10 Days for cohort II; 42 days for cohort IV, subgroup 1'}, {'measure': 'Biomarkers in AD lesions before and after multiple topical applications in subjects with AD (Cohorts I and IV, Subgroup 2)', 'timeFrame': '10 Days for cohort I, 42 days for cohort IV, subgroup 2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase Ib study is to investigate the safety, tolerability and pharmacokinetics of LEO 29102 2,5 mg/g cream when treating atopic dermatitis (AD) lesions from 10 up to 100% of the body surface area (BSA) twice daily (BID) for 7 days (Cohorts I, II, III) and from 10% up to 50% of BSA (bid) for 6 weeks (Cohort IV). This trial will be performed in four cohorts. Cohort I, II and III includes patients with a larger BSA that increases from one cohort to the next. After each cohort (Cohort I, II)a blinded evaluation of the safety and tolerability data will assess whether a stepwise increase in the percentage of "to be treated BSA" is justified. Cohort IV will start dosing after finalisation of Cohort II and after submission of data from Cohort I and II to the national authority and IEC for review.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of AD defined according to Hanifin and Rajka.\n2. Investigator Global Assessment scored as mild (2) to severe (4) AD.\n3. At screening, AD lesions amenable for treatment involving 10% to \\< 25% (Cohort I), 25% to \\< 50% (Cohort II), 50% to 100% (Cohort III) and 10% to \\< 50% (Cohort IV) of the total BSA.\n4. On Day -1, AD lesions amenable for treatment involving 10% to \\< 28% (Cohort I), 25% to \\< 55% (Cohort II), 50% to 100% (Cohort III) and 10% to \\< 55% (Cohort IV) of the total BSA.\n5. Adult male or female subjects, aged 18 to 65 years, inclusive.'}, 'identificationModule': {'nctId': 'NCT01447758', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'Safety, Tolerability and Pharmacokinetics of LEO 29102 Cream in Atopic Dermatitis. A Multicentre, Prospective, Randomised Phase Ib Study in Subjects Investigating Safety,Tolerability and Pharmacokinetics of LEO 29102 Cream (2.5 mg/g) When Treating Atopic Dermatitis Lesions Twice Daily for 7 Days (Cohorts I, II and III) and 6 Weeks (Cohort IV)', 'orgStudyIdInfo': {'id': 'LEO 29102-C26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LEO 29102 2,5 mg/g cream', 'interventionNames': ['Drug: LEO 29102']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'LEO 29102 Cream Vehicle', 'interventionNames': ['Drug: LEO 29102 Cream Vehicle']}], 'interventions': [{'name': 'LEO 29102', 'type': 'DRUG', 'description': 'Cream, 1,7mg/cm2 BSA, BID, 7 days In Cohort I, II and III, 6 weeks in Cohort IV', 'armGroupLabels': ['LEO 29102 2,5 mg/g cream']}, {'name': 'LEO 29102 Cream Vehicle', 'type': 'DRUG', 'description': 'Cream, 1,7mg/cm2 BSA, BID, 7 days in Cohort I and II, 6 weeks in Cohort IV', 'armGroupLabels': ['LEO 29102 Cream Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53105', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Klinik und Poliklinik für Dermatologie und Allergologie der Universität Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitätshautklinik Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Department of Dermatology, Johann Wolfgang Goethe-University', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '07584', 'city': 'Gera', 'country': 'Germany', 'facility': 'SRH Wald-Klinikum Gera gGmbH', 'geoPoint': {'lat': 50.88029, 'lon': 12.08187}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Clinical Trial Center North', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30449', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Universitätshautklinik Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Diamant Thaci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Goethe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}