Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-21 @ 2:07 PM
Study NCT ID:
NCT01967069
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2013-10-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kgulbronson@promiuspharma.com', 'phone': '609-282-1476', 'title': 'Director of Clinical Operations', 'organization': 'Promius Pharma'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Three subjects in the betamethasone dipropionate spray 0.05% group and two subjects in the vehicle spray group had no post-baseline safety evaluations.', 'eventGroups': [{'id': 'EG000', 'title': 'DFD01 Spray', 'description': 'DFD01 Spray twice daily\n\nDFD01 Spray', 'otherNumAtRisk': 179, 'otherNumAffected': 17, 'seriousNumAtRisk': 179, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vehicle Spray', 'description': 'Vehicle Spray twice daily\n\nVehicle Spray', 'otherNumAtRisk': 93, 'otherNumAffected': 24, 'seriousNumAtRisk': 93, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Application Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders'}, {'term': 'Application Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'Upper Gastrointestinal Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Infection Right Foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Exacerbation of Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFD01 Spray', 'description': 'DFD01 Spray twice daily\n\nDFD01 Spray'}, {'id': 'OG001', 'title': 'Vehicle Spray', 'description': 'Vehicle Spray twice daily\n\nVehicle Spray'}], 'classes': [{'categories': [{'measurements': [{'value': '21.50', 'groupId': 'OG000', 'lowerLimit': '15.5', 'upperLimit': '27.5'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '12.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', 'description': 'IGA of clear or almost clear', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DFD01 Spray', 'description': 'DFD01 Spray twice daily\n\nDFD01 Spray'}, {'id': 'FG001', 'title': 'Vehicle Spray', 'description': 'Vehicle Spray twice daily\n\nVehicle Spray'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DFD01 Spray', 'description': 'DFD01 Spray twice daily\n\nDFD01 Spray'}, {'id': 'BG001', 'title': 'Vehicle Spray', 'description': 'Vehicle Spray twice daily\n\nVehicle Spray'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '14.72', 'groupId': 'BG000'}, {'value': '49.9', 'spread': '12.90', 'groupId': 'BG001'}, {'value': '50.2', 'spread': '14.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': '% Body Surface Area', 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '3.72', 'groupId': 'BG000'}, {'value': '13.4', 'spread': '3.49', 'groupId': 'BG001'}, {'value': '13.6', 'spread': '3.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Participants with Moderate Psoriasis According to the Investigator's Global Assessment (IGA)", 'classes': [{'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 277}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'dispFirstSubmitDate': '2015-08-10', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2013-10-17', 'dispFirstSubmitQcDate': '2015-08-10', 'resultsFirstSubmitDate': '2016-08-15', 'studyFirstSubmitQcDate': '2013-10-17', 'dispFirstPostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-23', 'studyFirstPostDateStruct': {'date': '2013-10-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)", 'timeFrame': 'Day 15', 'description': 'IGA of clear or almost clear'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to compare the efficacy and safety of DFD01 Spray to Vehicle Spray for topical treatment of moderate plaque psoriasis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.\n\nSubjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.\n\nSubjects must have an IGA grade of 3 (moderate) at the Baseline Visit\n\nExclusion Criteria:\n\nCurrent diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).\n\nPresence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.\n\nHistory of psoriasis unresponsive to topical treatments. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.\n\nUse within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, or alefacept).\n\nHave received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed within 1 year of the Baseline Visit.\n\nUse within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).\n\nUse within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, and intranasal steroids are allowed.\n\nUse within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.\n\nRequire use of beta blockers, lithium, ACE inhibitors, and/or NSAIDs (indomethacin, ibuprofen, aspirin, naproxen) with a medical history that these medications affect the subject's psoriasis, except if the subject has been using the medication routinely during the 180 days prior to the Baseline Visit, these medications are allowed."}, 'identificationModule': {'nctId': 'NCT01967069', 'briefTitle': 'A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Primus Pharmaceuticals'}, 'orgStudyIdInfo': {'id': '1206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DFD01 Spray', 'description': 'DFD01 Spray twice daily', 'interventionNames': ['Drug: DFD01 Spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Spray', 'description': 'Vehicle Spray twice daily', 'interventionNames': ['Drug: Vehicle Spray']}], 'interventions': [{'name': 'DFD01 Spray', 'type': 'DRUG', 'armGroupLabels': ['DFD01 Spray']}, {'name': 'Vehicle Spray', 'type': 'DRUG', 'armGroupLabels': ['Vehicle Spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Coastal Clinical Research, Inc.', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85282', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hudson Dermatology/Clinical Research Advantage', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Specialists, Inc.', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University Clinical Trials, Inc', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Science Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Horizons Clinical Research Center, LLC', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Skin Care Research, Inc.', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'MOORE Clinical Research, Inc.', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'FXM Research Corop.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33162', 'city': 'North Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Dr. Tory P. Sullivan, MD, PA', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta Centre for Dermatology and Skin Renewal, LLC', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30078', 'city': 'Snellville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gwinnett Clinical Research Center, Inc.', 'geoPoint': {'lat': 33.85733, 'lon': -84.01991}}, {'zip': '40701', 'city': 'Corbin', 'state': 'Kentucky', 'country': 'United States', 'facility': 'MLFKnuckles, MD, PSC', 'geoPoint': {'lat': 36.9487, 'lon': -84.09688}}, {'zip': '70605', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Shondra L. Smith, MD Dermatology & Advanced Aesthetics', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Medical Center, New Center One', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48059', 'city': 'Fort Gratiot', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hamzavi Dermatology'}, {'zip': '48088', 'city': 'Warren', 'state': 'Michigan', 'country': 'United States', 'facility': 'Grekin Skin Institute', 'geoPoint': {'lat': 42.49044, 'lon': -83.01304}}, {'zip': '68144', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Skin Specialists P.C.', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89074', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Bettencourt Skin Center', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Skin Search of Rochester, Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '45249', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44483', 'city': 'Warren', 'state': 'Ohio', 'country': 'United States', 'facility': 'Brodell Medical, Inc.', 'geoPoint': {'lat': 41.23756, 'lon': -80.81842}}, {'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Paddington Testing Company, Inc.', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Clinical Studies, LTD, LLP', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermatology Clinical Research Center of San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Progressive Clinical Reesearch, PA', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22911', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Charlottesville Medical Research Center, LLC', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '99362', 'city': 'Walla Walla', 'state': 'Washington', 'country': 'United States', 'facility': 'Eastern Washington Dermatology', 'geoPoint': {'lat': 46.06458, 'lon': -118.34302}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Primus Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Prosoft Clinical', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}