Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-23 @ 2:29 PM
Study NCT ID:
NCT02416258
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2015-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088342', 'term': 'Aerosolized Particles and Droplets'}], 'ancestors': [{'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2015-04-09', 'studyFirstSubmitQcDate': '2015-04-13', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration)', 'timeFrame': 'End of treatment compared to baseline - 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Absolute change in single clinical sign score: erythema, scaling, infiltration', 'timeFrame': 'End of treatment and individual visits compared to baseline - 4 weeks'}, {'measure': 'Absolute Change in Total Clinical Score (TCS)', 'timeFrame': 'Individual visits compared to baseline - 4 weeks'}, {'measure': 'Absolute change in total skin thickness and echo-poor band thickness', 'timeFrame': 'End of treatment compared to baseline - 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psoriasis'], 'conditions': ['Skin and Connective Tissue Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.leopharmatrials.com/en', 'label': 'Clinical Trials at LEO Pharma'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated informed consent has been obtained\n* Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 6 different products.\n* Age 18 years or above\n* Outpatients\n* Female subjects must be of either\n\n * non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or,\n * child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.\n\nExclusion Criteria:\n\n* Female subjects who are breast feeding\n* Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:\n\n * Etanercept - within 4 weeks prior to randomisation and during the trial\n * Adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial\n * Ustekinumab - within 16 weeks prior to randomisation and during the trial\n * Other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer)\n* Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the trial,\n* Subjects using phototherapy within the following time periods prior to randomisation and during the trial:\n\n * PUVA: 4 weeks\n * UVB: 2 weeks\n* Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial:\n\n * Potent or very potent (WHO group III-IV) corticosteroids\n* Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial:\n\n * WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)\n * Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. calcineurin inhibitors), Tar products, Salicylic acid\n* Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial\n* Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the trial\n* Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis'}, 'identificationModule': {'nctId': 'NCT02416258', 'acronym': 'LP0113-1123', 'briefTitle': 'A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123)', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LP0113 Aerosol Spray Compared With Its Vehicle and With Daivobet® Gel, LEO 90100 Aerosol Foam, Betamethasone Dipropionate Aerosol Spray and Calcipotriol Aerosol Spray in the Treatment of Psoriasis Vulgaris', 'orgStudyIdInfo': {'id': 'LP0113-1123'}, 'secondaryIdInfos': [{'id': '2014-004759-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LP0113 aerosol spray', 'description': 'Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical', 'interventionNames': ['Drug: Aerosol spray vehicle', 'Drug: LEO 90100 aerosol foam', 'Drug: Betamethasone dipropionate aerosol spray', 'Drug: Calcipotriol aerosol spray', 'Drug: Daivobet® gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Aerosol spray vehicle', 'description': 'No active ingredient, topical', 'interventionNames': ['Drug: LP0113 aerosol spray', 'Drug: LEO 90100 aerosol foam', 'Drug: Betamethasone dipropionate aerosol spray', 'Drug: Calcipotriol aerosol spray', 'Drug: Daivobet® gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LEO 90100 aerosol foam', 'description': 'Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical', 'interventionNames': ['Drug: LP0113 aerosol spray', 'Drug: Aerosol spray vehicle', 'Drug: Betamethasone dipropionate aerosol spray', 'Drug: Calcipotriol aerosol spray', 'Drug: Daivobet® gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Betamethasone dipropionate aerosol spray', 'description': 'Betamethasone (as dipropionate) 0.5 mg/g, topical', 'interventionNames': ['Drug: LP0113 aerosol spray', 'Drug: Aerosol spray vehicle', 'Drug: LEO 90100 aerosol foam', 'Drug: Calcipotriol aerosol spray', 'Drug: Daivobet® gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Calcipotriol aerosol spray', 'description': 'Calcipotriol (as monohydrate) 50 mcg/g, topical', 'interventionNames': ['Drug: LP0113 aerosol spray', 'Drug: Aerosol spray vehicle', 'Drug: LEO 90100 aerosol foam', 'Drug: Betamethasone dipropionate aerosol spray', 'Drug: Daivobet® gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Daivobet® gel', 'description': 'Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical', 'interventionNames': ['Drug: LP0113 aerosol spray', 'Drug: Aerosol spray vehicle', 'Drug: LEO 90100 aerosol foam', 'Drug: Betamethasone dipropionate aerosol spray', 'Drug: Calcipotriol aerosol spray']}], 'interventions': [{'name': 'LP0113 aerosol spray', 'type': 'DRUG', 'armGroupLabels': ['Aerosol spray vehicle', 'Betamethasone dipropionate aerosol spray', 'Calcipotriol aerosol spray', 'Daivobet® gel', 'LEO 90100 aerosol foam']}, {'name': 'Aerosol spray vehicle', 'type': 'DRUG', 'armGroupLabels': ['Betamethasone dipropionate aerosol spray', 'Calcipotriol aerosol spray', 'Daivobet® gel', 'LEO 90100 aerosol foam', 'LP0113 aerosol spray']}, {'name': 'LEO 90100 aerosol foam', 'type': 'DRUG', 'armGroupLabels': ['Aerosol spray vehicle', 'Betamethasone dipropionate aerosol spray', 'Calcipotriol aerosol spray', 'Daivobet® gel', 'LP0113 aerosol spray']}, {'name': 'Betamethasone dipropionate aerosol spray', 'type': 'DRUG', 'armGroupLabels': ['Aerosol spray vehicle', 'Calcipotriol aerosol spray', 'Daivobet® gel', 'LEO 90100 aerosol foam', 'LP0113 aerosol spray']}, {'name': 'Calcipotriol aerosol spray', 'type': 'DRUG', 'armGroupLabels': ['Aerosol spray vehicle', 'Betamethasone dipropionate aerosol spray', 'Daivobet® gel', 'LEO 90100 aerosol foam', 'LP0113 aerosol spray']}, {'name': 'Daivobet® gel', 'type': 'DRUG', 'armGroupLabels': ['Aerosol spray vehicle', 'Betamethasone dipropionate aerosol spray', 'Calcipotriol aerosol spray', 'LEO 90100 aerosol foam', 'LP0113 aerosol spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}