Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT01286220
Status:
TERMINATED
Last Update Posted:
2020-03-20
First Post:
2011-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': 'the study was terminated due to participant drop out', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-18', 'studyFirstSubmitDate': '2011-01-26', 'studyFirstSubmitQcDate': '2011-01-28', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eczema Area and Severity Index Score (EASI)', 'timeFrame': 'Change in EASI score from baseline at 1 month and 3 month follow ups', 'description': 'EASI score is recorded at baseline, 1 month and 3 month follow ups.'}], 'secondaryOutcomes': [{'measure': "Investigator's Global Assessment (IGA)", 'timeFrame': 'Change in IGA score from baseline at 1 month and 3month follow ups', 'description': 'IGA scores are recorded at baseline, 1 month and 3 month follow ups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Moderate to Severe Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '19403473', 'type': 'RESULT', 'citation': 'Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14. doi: 10.1542/peds.2008-2217.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if twice weekly 10 minute dilute bleach baths decreases disease severity in patients with moderate to severe atopic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2-17 years of age at time of consent. A parent or legal guardian will be required to consent and authorize their enrollment in the study.\n* Male or female of any ethnic background.\n* English or Spanish speaking.\n* A clinical diagnosis of atopic dermatitis for at least 6 months prior to enrollment.\n* Must have moderate to severe atopic dermatitis as rated by the EASI score.\n* Able to adhere to study visit schedule and other protocol requirements.\n* Patients and/or family members must agree to not use any other prescription or over the counter medications other than the ones prescribed by the study protocol.\n\nExclusion Criteria:\n\n* Clinical evidence of bacterial or viral superinfection on first visit.\n* Have received phototherapy within 2 months prior to enrollment.\n* Have received any systemic medication for atopic dermatitis or any that may affect evaluation of atopic dermatitis within 2 months prior to enrollment.\n* Have a known hypersensitivity response, including anaphylaxis, to any of the topicals used for treatment (i.e. topical steroids, bleach)\n* Participation in another clinical trial using an investigational agent or procedure.\n* Pregnant or planning pregnancy or surgery during the participation in the study.'}, 'identificationModule': {'nctId': 'NCT01286220', 'briefTitle': 'Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'A Randomized, Controlled, Evaluator-blinded Study to Evaluate the Efficacy of Dilute Bleach Baths on Skin Disease Control in Pediatric Patients With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'STU 012010-059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dilute bleach baths', 'description': 'Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes.', 'interventionNames': ['Other: Dilute bleach baths']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Water', 'description': 'Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes.', 'interventionNames': ['Other: Water']}], 'interventions': [{'name': 'Dilute bleach baths', 'type': 'OTHER', 'description': 'Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes.', 'armGroupLabels': ['Dilute bleach baths']}, {'name': 'Water', 'type': 'OTHER', 'description': 'Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes.', 'armGroupLabels': ['Water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center of Dallas", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Medical Center Dallas", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}