Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT02940002
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2016-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002990', 'term': 'Clobetasol'}, {'id': 'C517164', 'term': 'betamethasone dipropionate, calcipotriol drug combination'}], 'ancestors': [{'id': 'D001623', 'term': 'Betamethasone'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-20', 'studyFirstSubmitDate': '2016-10-19', 'studyFirstSubmitQcDate': '2016-10-19', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in infiltrate thickness from day 1 to day 29 measured by sonography using 22 MHz B mode ultrasound', 'timeFrame': 'Day 1 to 29'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Plaque form psoriasis vulgaris'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'To explore the efficacy and safety of four BAY1003803 formulations by means of a within subject comparison in an open Psoriasis Plaque Test'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female (non-childbearing potential) volunteer with stable plaque-type psoriasis, but otherwise healthy\n* Age: 18-64 years\n\nExclusion Criteria:\n\n* Severe disease within the last 4 weeks prior to the first study drug administration as determined by the investigator\n* Any topical antipsoriatics on plaques potentially to be treated in this trial (including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol and tar, except for salicylic acid (Pretreatment) in the 4 weeks before first treatment and/or planned during the trial, except for allowed topical treatment on the face, ears and scalp\n* Systemic treatment depending on kind of treatment within 4 weeks and 6 months prior and/or planned during the trial\n* Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g. antimalarial drugs, lithium, beta-blockers or angiotensin-converting-enzyme inhibitors (AEC inhibitors) unless on a stable dose for 3 months before study medication initiation\n* Clinico-chemical parameters of clinically significant deviation'}, 'identificationModule': {'nctId': 'NCT02940002', 'briefTitle': 'BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A 28-day, Double-blind, Randomized, Reference-controlled Psoriasis Plaque Test to Evaluate the Efficacy and Safety of Two Different BAY1003803 Formulation Types in 2 Concentrations Each in Treatment of Symptomatic Volunteers With Plaque-type Psoriasis', 'orgStudyIdInfo': {'id': '17012'}, 'secondaryIdInfos': [{'id': '2016-000962-47', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAY1003803 0.1% lipophilic cream', 'description': 'BAY1003803 0.1% lipophilic cream (on plaque and healthy skin)', 'interventionNames': ['Drug: BAY1003803']}, {'type': 'EXPERIMENTAL', 'label': 'BAY1003803 0.1% ointment', 'description': 'BAY1003803 0.1% ointment (on plaque and healthy skin)', 'interventionNames': ['Drug: BAY1003803']}, {'type': 'EXPERIMENTAL', 'label': 'BAY1003803 0.01% lipophilic cream', 'description': 'BAY1003803 0.01% lipophilic cream (on plaque and healthy skin)', 'interventionNames': ['Drug: BAY1003803']}, {'type': 'EXPERIMENTAL', 'label': 'BAY1003803 0.01% ointment', 'description': 'BAY1003803 0.01% ointment (on plaque and healthy skin)', 'interventionNames': ['Drug: BAY1003803']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clobetasol propionate', 'description': 'Clobetasol propionate ointment 0.05 % (on plaque and healthy skin)', 'interventionNames': ['Drug: Clobetasol propionate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Betamethasone/calcipotriene', 'description': 'Betamethasone/calcipotriene ointment 0.05 %/0.005% (on healthy skin)', 'interventionNames': ['Drug: Betamethasone/calcipotriene']}], 'interventions': [{'name': 'BAY1003803', 'type': 'DRUG', 'description': 'Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect', 'armGroupLabels': ['BAY1003803 0.01% lipophilic cream', 'BAY1003803 0.01% ointment', 'BAY1003803 0.1% lipophilic cream', 'BAY1003803 0.1% ointment']}, {'name': 'Clobetasol propionate', 'type': 'DRUG', 'description': 'Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect', 'armGroupLabels': ['Clobetasol propionate']}, {'name': 'Betamethasone/calcipotriene', 'type': 'DRUG', 'description': 'Simultaneous application of 10μl on healthy skin for 4 weeks and evaluation of pharmacodynamic effect', 'armGroupLabels': ['Betamethasone/calcipotriene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20095', 'city': 'Hamburg', 'state': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '19055', 'city': 'Schwerin', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'geoPoint': {'lat': 53.62937, 'lon': 11.41316}}, {'zip': '44803', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}