Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-02-08 @ 7:45 AM
Study NCT ID:
NCT01743118
Status:
COMPLETED
Last Update Posted:
2013-07-17
First Post:
2012-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antipsoriatic Effect of a Topical Formulation for the Treatment of Psoriasis Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C055085', 'term': 'calcipotriene'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-16', 'studyFirstSubmitDate': '2012-12-03', 'studyFirstSubmitQcDate': '2012-12-05', 'lastUpdatePostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of plaque thickness-reducing efficacy measured by 20 MHz sonography of psoriatic infiltrate', 'timeFrame': 'Up to Day 12'}], 'secondaryOutcomes': [{'measure': 'Evaluation of anti-psoriatic efficacy by clinical assessment', 'timeFrame': 'Up to day 12'}, {'measure': 'Number of subjects with Adverse Events', 'timeFrame': 'Up to day 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psoriasis Vulgaris']}, 'descriptionModule': {'briefSummary': 'The current most important topical treatments for psoriasis are vitamin D3 analogues and/or corticosteroids. The possibility of another effective treatment for psoriasis could be based on the immunosuppressive efficacy of selective blockers of a lymphocyte potassium channel.\n\nThe aim of the clinical trial is to evaluate the safety, tolerability and anti-psoriatic efficacy of topical SPS4251 formulations in comparison to placebo and to a marketed topical Vitamin-D analogue ointment in a psoriasis plaque test.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men aged 18 years or older\n* subjects with mild to moderate psoriasis vulgaris in a chronic stable phase\n* subject with up to three stable plaques with an area sufficient for five treatment fields\n* Plaques to be treated should have a comparable thickness of the Echo Lucent Band of at least 200 µm\n\nExclusion Criteria:\n\n* Subjects with guttate psoriasis, punctate psoriasis, erythrodermic psoriasis, psoriatic arthropathy and pustular psoriasis\n* Local treatment with antipsoriatics in the 4 weeks preceding and/or during the trial, and any topical antipsoriatic treatment on the plaques to be treated in this trial in the 8 weeks before first treatment and/or during the trial\n* Systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids in the three months before first treatment and during the trial;\n* Treatment with systemic medications or medications acting locally which might have countered or influenced the trial aim\n* Contraindications according to summary of product characteristics of Daivonex® Ointment;\n* UV-therapy within four weeks before first treatment and during the trial\n* Symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before baseline visit and during the trial\n* Any history of cardiovascular disease\n* Any evidence of ECG abnormality on screening ECG\n* Close affiliation with the Investigator (e.g. a close relative) or persons working at bioskin GmbH or subject is an employee of the Sponsor;\n* Subject is institutionalized because of legal or regulatory order.'}, 'identificationModule': {'nctId': 'NCT01743118', 'briefTitle': 'Antipsoriatic Effect of a Topical Formulation for the Treatment of Psoriasis Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Circassia Limited'}, 'officialTitle': 'Phase Ib, Two-centre, Randomised, Observer-blind, Placebo- and Comparator Controlled Trial to Evaluate the Safety, Tolerability and Antipsoriatic Efficacy of Three Strengths of a Topical SPS4251 Formulation in a Psoriasis Plaque Test', 'orgStudyIdInfo': {'id': 'SP001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psoriasis Plaque Test', 'description': 'SPS4251 Ointment, 0.01%; SPS4251 Ointment, 0.1%; SPS4251 Ointment, 1%; SPS4251 Placebo, Daivonex® ointment', 'interventionNames': ['Drug: SPS4251 Ointment', 'Drug: Placebo', 'Drug: Daivonex® ointment']}], 'interventions': [{'name': 'SPS4251 Ointment', 'type': 'DRUG', 'description': 'Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments)', 'armGroupLabels': ['Psoriasis Plaque Test']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments)', 'armGroupLabels': ['Psoriasis Plaque Test']}, {'name': 'Daivonex® ointment', 'type': 'DRUG', 'otherNames': ['calcipotriol'], 'description': 'Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments).', 'armGroupLabels': ['Psoriasis Plaque Test']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Bioskin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Bioskin', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Circassia Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bioskin GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}