Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-02-20 @ 2:10 AM
Study NCT ID:
NCT01675232
Status:
COMPLETED
Last Update Posted:
2014-07-29
First Post:
2012-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-25', 'studyFirstSubmitDate': '2012-08-02', 'studyFirstSubmitQcDate': '2012-08-25', 'lastUpdatePostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Effect of corticosteroid ointment application regimens on serum cortisol', 'timeFrame': '2 weeks after application of topical corticosteroids'}, {'measure': 'Frequency of atopic dermatitis flares in the 3 months following the two-week treatment regimen', 'timeFrame': '3 months'}, {'measure': 'Adverse effects associated with each corticosteroid application regimen', 'timeFrame': '3 months', 'description': 'Characterize and quantify adverse effects associated with each corticosteroid application regimen.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atopic dermatitis', 'Topical corticosteroid', 'Pediatric', 'Eczema'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy of two different corticosteroid ointment application regimens for the treatment of eczema (atopic dermatitis).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the clinical criteria for the diagnosis of atopic dermatitis\n* Have disease over at least 5% of their total body surface area.\n* Less than 18 years of age.\n* Families able to comprehend written instructions in English and able to complete questionnaires with assistance if needed.\n* Parents/guardians able to understand and willing to sign a parental permission form.\n* Children between the ages of 7-17 years willing to sign an age-appropriate assent form.\n\nExclusion Criteria:\n\n* Patients who are allergic or intolerant of the topical medications employed in this study.\n* Lack of follow-up after initial visit or regimen noncompliance.\n* Patients who do not have access to a bathtub.'}, 'identificationModule': {'nctId': 'NCT01675232', 'briefTitle': 'A Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'A Randomized, Investigator-Blinded Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'HIC-1206010366'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Soak and smear', 'description': 'Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment immediately to wet skin once a day and dry skin once a day.', 'interventionNames': ['Other: Soak and smear']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dry smear', 'description': 'Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment to dry skin twice a day.', 'interventionNames': ['Other: Dry Smear']}], 'interventions': [{'name': 'Soak and smear', 'type': 'OTHER', 'description': 'Corticosteroid ointment applied to wet skin once a day and dry skin once a day.', 'armGroupLabels': ['Soak and smear']}, {'name': 'Dry Smear', 'type': 'OTHER', 'description': 'Corticosteroid ointment applied to dry skin twice a day.', 'armGroupLabels': ['Dry smear']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Richard J Antaya, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Dermatology and Pediatrics', 'investigatorFullName': 'Richard Antaya', 'investigatorAffiliation': 'Yale University'}}}}