Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT01529320
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2012-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C078007', 'term': 'methylprednisolone aceponate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2012-02-06', 'studyFirstSubmitQcDate': '2012-02-06', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean time to Itch Relief (TR) from the start of treatment, with methylprednisolone aceponate.', 'timeFrame': '5 days', 'description': 'Time to Itch Relief is defined as the time needed to reach a 30% decrease of the maximum VAS (Visual Analogue Scale used for self-assessment of itch by the volunteers) recorded after the start of treatment.'}], 'secondaryOutcomes': [{'measure': 'Erythema intensity by colorimetry.', 'timeFrame': '5 days'}, {'measure': 'Eczema intensity by planimetric morphology (ICDRG scale)', 'timeFrame': '5 days'}, {'measure': 'VAS versus time curve (time to reach VAS max from the start of treatment, AUC, dVAS/dT)', 'timeFrame': '5 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Contact Eczema']}, 'descriptionModule': {'briefSummary': 'Determine the mean time to itch relief from the start of treatment with topic methylprednisolone aceponate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects ≥18 years old.\n2. Subjects with a history of diagnosis of sensitization to Nickel sulphate.\n3. Delayed type hypersensitivity demonstrated by positive reaction with epicutaneous or patch test.\n4. Skin Phototype II-III.\n5. Women with fertile age and a negative result in the pregnancy test before inclusion. Women must use an adequate contraceptive method during the study.\n6. Written informed consent prior to inclusion.\n7. Able and willing to comply with protocol procedures and to follow the investigator's instructions.\n\nCriteria for treatment initiation: At day 7, before starting treatment, subjects must meet the inclusion criteria and all the following criteria: ≥ 3 VAS and eczema intensity of (+ +) or (+++) according to ICDRG scale.\n\nExclusion Criteria:\n\n1. Active cutaneous disease causing itch (active eczema, urticaria or insect bites)\n2. Active systemic disease that may induce itch (hepatic or renal disease).\n3. Active psychiatric disease that could interfere with symptom assessment.\n4. Treatment with drugs inducing itch.\n5. Treatment with oral or topical preparations that could interfere with the itching sensation induced by patch test.\n6. Treatment with systemic or topical corticosteroids, antihistaminics or calcineurin inhibitors.\n7. Active skin disease in the back that may interfere with the assessment of response to topical application of allergen\n8. Pregnancy or lactation\n9. Subjects with contraindications specified in Summary of Product Characteristics (SPC)."}, 'identificationModule': {'nctId': 'NCT01529320', 'briefTitle': 'Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion IMIM'}, 'officialTitle': 'Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study).', 'orgStudyIdInfo': {'id': 'GIM-MPA-2011-01'}, 'secondaryIdInfos': [{'id': '2011-005284-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adventan® (metilprednisolona aceponato 0,1%)', 'interventionNames': ['Drug: Adventan® (methylprednisolone aceponate 0,1%)']}], 'interventions': [{'name': 'Adventan® (methylprednisolone aceponate 0,1%)', 'type': 'DRUG', 'description': 'Doses: 1/4 FTU (Finger Tip Unit) during 5 days (Day 7-Day 11). Procedure: Patch Test (Nickel sulphate 5%) during 2 days (Day 0- Day 2.', 'armGroupLabels': ['Adventan® (metilprednisolona aceponato 0,1%)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Dermatology Service, Hospital del Mar, Parc de Salut Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion IMIM', 'class': 'OTHER'}, 'collaborators': [{'name': 'Adknoma Health Research', 'class': 'INDUSTRY'}, {'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ana Maria Gimenez Arnau', 'investigatorAffiliation': 'Fundacion IMIM'}}}}