Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-30 @ 10:14 AM
Study NCT ID:
NCT01085851
Status:
UNKNOWN
Last Update Posted:
2010-03-12
First Post:
2010-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Sunburn Related Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013471', 'term': 'Sunburn'}], 'ancestors': [{'id': 'D010787', 'term': 'Photosensitivity Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002056', 'term': 'Burns'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C018904', 'term': 'dexchlorpheniramine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'lastUpdateSubmitDate': '2010-03-11', 'studyFirstSubmitDate': '2010-03-11', 'studyFirstSubmitQcDate': '2010-03-11', 'lastUpdatePostDateStruct': {'date': '2010-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS)', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Composite clinical evaluation of erythema, pruritus and burning sensation performed by the investigator using a 4-point scale for each one of the variables (absent, mild, moderate, intense).', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sunburn', 'Dexchlorpheniramine', 'Lotion', 'Cream'], 'conditions': ['Sunburn']}, 'descriptionModule': {'briefSummary': 'Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signs of solar erythema of mild to moderate intensity resulting from voluntary exposure to sun within the last 72 hours\n* Presence of lesions with some degree of symmetry to allow comparison between both pharmaceutical formulations\n* Compliance of the subject to the treatment protocol\n* Agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old\n\nExclusion Criteria:\n\n* Pregnancy or risk of pregnancy\n* Lactation\n* Signs of solar erythema of severe intensity\n* Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study\n* History of atopy or allergic diseases\n* History of allergy to any component of the formulations\n* Other conditions considered by the investigator as reasonable for non-eligibility'}, 'identificationModule': {'nctId': 'NCT01085851', 'briefTitle': 'Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Sunburn Related Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mantecorp Industria Quimica e Farmaceutica Ltd.'}, 'officialTitle': 'Non-inferiority, Monocentric Comparative Open Study of Two Topical Pharmaceutical Preparations (Cream and Lotion) of Dexchlorpheniramine Maleate in the Evaluation of Safety and Efficacy for the Relief of Sunburn Related Symptoms', 'orgStudyIdInfo': {'id': 'ERE 976-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexchlorpheniramine 1% lotion', 'interventionNames': ['Drug: Dexchlorpheniramine 1% lotion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexchlorpheniramine 1% cream', 'interventionNames': ['Drug: Dexchlorpheniramine 1% cream']}], 'interventions': [{'name': 'Dexchlorpheniramine 1% lotion', 'type': 'DRUG', 'description': 'Small amount applied over the lesion twice a day for 7 days', 'armGroupLabels': ['Dexchlorpheniramine 1% lotion']}, {'name': 'Dexchlorpheniramine 1% cream', 'type': 'DRUG', 'description': 'Small amount applied over the lesion twice a day for 7 days', 'armGroupLabels': ['Dexchlorpheniramine 1% cream']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Patrícia C Pinto', 'role': 'CONTACT'}], 'facility': 'Medcin Instituto da Pele Ltda', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Sérgio Schalka, MD', 'role': 'CONTACT', 'phone': '+551136811334'}], 'overallOfficials': [{'name': 'Sérgio Schalka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medcin Instituto da Pele Ltda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mantecorp Industria Quimica e Farmaceutica Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Celso Pereira Sustovich, Medical Director', 'oldOrganization': 'Mantecorp Industria Quimica e Farmaceutica Ltd.'}}}}