Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-25 @ 12:56 AM
Study NCT ID:
NCT02606760
Status:
COMPLETED
Last Update Posted:
2018-03-08
First Post:
2015-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Nails Affected by Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 378}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-06', 'studyFirstSubmitDate': '2015-11-11', 'studyFirstSubmitQcDate': '2015-11-13', 'lastUpdatePostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total Nail Psoriasis Severity Index (NAPSI)', 'timeFrame': 'Baseline - Week 24'}], 'secondaryOutcomes': [{'measure': 'Change in NAPSI matrix', 'timeFrame': 'Baseline - Week 24'}, {'measure': 'Change in NAPSI bed', 'timeFrame': 'Week 24'}, {'measure': 'Nail Physician Global Assessment (PGA) response rate', 'timeFrame': 'Week 24'}, {'measure': "Change in patient's quality-of-life by means of the Dermatology Life Quality Index (DLQI)", 'timeFrame': 'Baseline - Week 24'}, {'measure': 'Change in discomfort by means of the Visual Analogue Scale (VAS)', 'timeFrame': 'Week 24'}, {'measure': 'Proportions of nails with improvement in total NAPSI', 'timeFrame': 'Week 24'}, {'measure': 'Proportions of nails with improvement in NAPSI Matrix', 'timeFrame': 'Week 24'}, {'measure': 'Proportions of nails with improvement in NAPSI bed', 'timeFrame': 'Week 24'}, {'measure': 'Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation.', 'timeFrame': 'Week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nail psoriasis'], 'conditions': ['Nail Psoriasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm the clinical efficacy and the safety of P-3073 in patients affected by isolated psoriatic nail(s) and/or those with psoriatic nails and concomitant mild to moderate plaque psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent before starting any study related procedures\n* Patients aged 18 to 80 years old of any race.\n* Males or females.\n* Patients with mild to moderate psoriastic fingernail(s) defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score ≥ 1 and ≤ 3 at baseline.\n* In case of skin involvement, patients with established clinical diagnosis of mild-to-moderate psoriasis (BSA involvement ≤ 8% or PASI ≤ 10)\n\nExclusion Criteria:\n\n* Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.\n* Use of any systemic treatment for psoriasis during the last six months before the screening visit.\n* Use of photochemotherapy or other forms of radiotherapy during the last four weeks before the screening visit.\n* Positive mycology findings\n* Systemic use of immunosuppressives, chemotherapy and corticosteroids during last three months before the screening visit.\n* Consumption of Vitamin D or its analogues during the last three months.\n* History of hypercalcaemia or hypercalciuria.\n* HIV infection or any other immunodeficiency.\n* Alcohol or substance abuse.\n* Patients with history of allergic reactions to calcipotriol or its excipients.'}, 'identificationModule': {'nctId': 'NCT02606760', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Nails Affected by Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Polichem S.A.'}, 'officialTitle': 'A Randomized, Double-blind, Vehicle-controlled, Parallel Group Trial to Assess the Efficacy, Safety and Tolerability of P-3073 for Topical Treatment of Nail Psoriasis', 'orgStudyIdInfo': {'id': 'PM1434'}, 'secondaryIdInfos': [{'id': '2015-002365-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'P-3073', 'description': 'P-3073', 'interventionNames': ['Drug: P-3073']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'vehicle of P-3073', 'description': 'vehicle of P-3073', 'interventionNames': ['Drug: Vehicle of P-3073']}], 'interventions': [{'name': 'P-3073', 'type': 'DRUG', 'armGroupLabels': ['P-3073']}, {'name': 'Vehicle of P-3073', 'type': 'DRUG', 'armGroupLabels': ['vehicle of P-3073']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Bulgaria'}, {'city': 'Multiple Locations', 'country': 'Czechia'}, {'city': 'Multiple Locations', 'country': 'Germany'}, {'city': 'Multiple Locations', 'country': 'Greece'}, {'city': 'Multiple Locations', 'country': 'Latvia'}, {'city': 'Multiple Locations', 'country': 'Poland'}, {'city': 'Multiple Locations', 'country': 'Russia'}], 'overallOfficials': [{'name': 'Maurizio Caserini, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Polichem S.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Polichem S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}