Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT01228656
Status:
SUSPENDED
Last Update Posted:
2022-11-03
First Post:
2008-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate
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': 'D000068656', 'term': 'Mometasone Furoate'}, {'id': 'D020156', 'term': 'Salicylic Acid'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2011-10'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2008-02-07', 'studyFirstSubmitQcDate': '2010-10-25', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluating the effectiveness and comparative isolation of the association mometasone furoate + salicylic acid and the substance isolated mometasone furoate', 'timeFrame': '2 months of treatment.'}], 'secondaryOutcomes': [{'measure': 'Evaluation by means of analytical propedeutics medical improvement in clinical signs and symptoms related to plaque psoriasis.', 'timeFrame': '2 months of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psoriasis'], 'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'The aims is to evaluate the efficacy and comparative isolation of the association Mometasone furoate + Salicylic Acid and the substance isolated Mometasone furoate produced by the Laboratory Glenmark Pharmaceuticals Ltd. in patients of both sexes, patients with plaque psoriasis grade mild to moderate.', 'detailedDescription': 'The specific objective is to evaluate through analytical propedeutics medical improvement in clinical signs and symptoms related to plaque psoriasis. The study will be conducted with 40 patients who will deal with two symmetrical lesions of his body being identified by the clinician that a party should be treated in a double-blind only with mometasone furoate cream containing 0.1% and another with the combination of furoate of mometasone 0.1% + Salicylic Acid 5%. The group of patients to be treated must be adults of both sexes, aged 18-70 years with good mental and physical health to sign the Informed Consent and who are clinically assessed by dermatologists in the study as having mild plaque psoriasis and moderate. The association made a proposal of effectiveness was developed and is produced by the Laboratory Glenmark Pharmaceuticals Ltd., as well as its isolated version of the pilot (mometasone furoate 0.1%). This study should be characterized as Phase II multicenter not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults of both sexes, regardless of color or social class;\n* Age 18 or older, with good mental health;\n* Patients with plaque psoriasis of mild to moderate;\n* Patients who agree to participate and sign the Informed Consent and\n* Clarified (appendix);\n* Patients who agree to return for follow-up visits.\n\nExclusion Criteria:\n\n* Patients who are making use of biologics, steroids or steroidal anti-inflammatory and non-steroidal or who made use of these topical medications until 15 days ago 30 days ago or when occurred in oral administration;\n* Patients who are exposing themselves to the sun 15 days before the study began or during the course of the same.\n* Patients who are making use of acetaminophen;\n* Patients who do not agree to the terms described in the informed consent Informed Consent;\n* Patients who also have psoriatic plaques of skin disorders caused by fungi or bacteria and who are making use of antimycotics or antibiotics;\n* Lions and other types of skin damage than those psoriasis;\n* Pregnant and nursing women;\n* Patients using oral anticoagulants.'}, 'identificationModule': {'nctId': 'NCT01228656', 'acronym': 'Psoriasis', 'briefTitle': 'Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Azidus Brasil'}, 'officialTitle': 'CLINICAL EVALUATION OF EFFECTIVENESS OF ASSOCIATION MOMETASONE FUROATE 0.1% AND SALICYLIC ACID 5% COMPARED WITH 0.1% MOMETASONE FUROATE INSULATED TOPICAL USE OF LABORATORY Glenmark Pharmaceuticals Ltd, IN PATIENTS WITH PSORIASIS IN PLATE', 'orgStudyIdInfo': {'id': 'SALMOGLEN10906'}, 'secondaryIdInfos': [{'id': 'Psoriasis'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '-mometasone furoate associated with salicylic acid', 'interventionNames': ['Drug: mometasone furoate + salicylic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': '-mometasone furoate', 'interventionNames': ['Drug: Mometasone furoate']}], 'interventions': [{'name': 'mometasone furoate + salicylic acid', 'type': 'DRUG', 'description': 'Dermatologic ointment applied once a day.', 'armGroupLabels': ['-mometasone furoate associated with salicylic acid']}, {'name': 'Mometasone furoate', 'type': 'DRUG', 'description': 'Dermatologic ointment applied once a day', 'armGroupLabels': ['-mometasone furoate']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alexandre Frederico, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LAL Clinical Reseach e Development Ltda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azidus Brasil', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator Dr. Alexandre Frederico', 'investigatorFullName': 'Azidus Brasil', 'investigatorAffiliation': 'Azidus Brasil'}}}}