Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-04 @ 4:17 PM
Study NCT ID:
NCT04831892
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2021-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Isosorbide Diesters Based Moisturizer on Skin Health
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-05', 'studyFirstSubmitDate': '2021-04-01', 'studyFirstSubmitQcDate': '2021-04-01', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EASI75', 'timeFrame': 'Week 4', 'description': '75% improvement in Eczema severity is assessed using the Eczema Area and Severity Index'}, {'measure': 'Change in IVAS', 'timeFrame': '4 weeks', 'description': 'Itch severity is assessed using the Itch Visual Analog Scale.'}], 'secondaryOutcomes': [{'measure': 'Change in EASI score', 'timeFrame': 'Week 1', 'description': 'Eczema severity is assessed using the Eczema Area and Severity Index.'}, {'measure': 'Change in EASI score', 'timeFrame': 'Week 5', 'description': 'Eczema severity is assessed using the Eczema Area and Severity Index.'}, {'measure': 'Change in IVAS', 'timeFrame': 'Week 1', 'description': 'Itch severity is assessed using the Itch Visual Analog Scale.'}, {'measure': 'Change in IVAS', 'timeFrame': 'Week 5', 'description': 'Itch severity is assessed using the Itch Visual Analog Scale.'}, {'measure': 'Change in TEWL', 'timeFrame': 'Week 1', 'description': 'Transepidermal water loss (TEWL) is measured with a skin vapometer.'}, {'measure': 'Change in TEWL', 'timeFrame': 'Week 4', 'description': 'Transepidermal water loss (TEWL) is measured with a skin vapometer.'}, {'measure': 'Change in TEWL', 'timeFrame': 'Week 5', 'description': 'Transepidermal water loss (TEWL) is measured with a skin vapometer.'}, {'measure': 'Change in skin hydration level', 'timeFrame': 'Week 1', 'description': 'Skin hydration levels are measured using a moisture meter.'}, {'measure': 'Change in skin hydration level', 'timeFrame': 'Week 4', 'description': 'Skin hydration levels are measured using a moisture meter.'}, {'measure': 'Change in skin hydration level', 'timeFrame': 'Week 5', 'description': 'Skin hydration levels are measured using a moisture meter.'}, {'measure': 'Change in DLQI survey responses', 'timeFrame': 'Week 1', 'description': 'Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.'}, {'measure': 'Change in DLQI survey responses', 'timeFrame': 'Week 4', 'description': 'Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.'}, {'measure': 'Change in DLQI survey responses', 'timeFrame': 'Week 5', 'description': 'Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.'}, {'measure': 'Change in relative abundance of S. aureus', 'timeFrame': '4 weeks', 'description': 'Skin microbiome related measurement of S. aureus relative abundance'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eczema', 'skin', 'dermatology', 'isosorbide diesters', 'skin microbiome'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '38394048', 'type': 'DERIVED', 'citation': 'Nadora D, Burney W, Chaudhuri RK, Galati A, Min M, Fong S, Lo K, Chambers CJ, Sivamani RK. Prospective Randomized Double-Blind Vehicle-Controlled Study of Topical Coconut and Sunflower Seed Oil-Derived Isosorbide Diesters on Atopic Dermatitis. Dermatitis. 2024 Jan-Feb;35(S1):S62-S69. doi: 10.1089/derm.2023.0329.'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of this study is to assess how a natural ingredient, isosorbide diesters (IDEAS), works in association with colloidal oatmeal for eczema.', 'detailedDescription': 'The topical therapy of eczema largely focuses on the use of topical medications but there is demand for topical moisturizers and ingredients that can reduce the need for topical steroids. The goal of this study is to assess the use of a natural ingredient, isosorbide diesters (IDEAS), for eczema and if it can reduce the need for the use of topical steroids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 or over\n* Subjects with a diagnosis of mild to moderate eczema with a SCORAD between 1-50.\n\nExclusion Criteria:\n\n* Individuals who have a known allergy to isosorbide diesters.\n* Individuals who have solely hand and/or foot eczema without evidence of eczema anywhere else on their body.\n* Individuals who have been on topical calcineurin inhibitors or crisaborole to the predetermined areas within two weeks of initiation of participation or unwilling to undergo a washout period.\n* Subjects with an ongoing secondary infection of the skin.\n* Subjects who are on systemic therapy or who need systemic therapy at the discretion of the investigator. Systemic therapies include cyclosporine, systemic steroids, methotrexate, and dupilumab. Subjects who have been on cyclosporine, systemic steroids, or methotrexate in the month prior to initiation of study intervention or are unwilling to undergo a washout period. Subjects who have been on dupilumab in two months prior to initiation of study intervention or are unwilling to undergo a washout period.\n* Subjects with a diagnosis of Scabies.\n* Pregnant women\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT04831892', 'briefTitle': 'The Effect of Isosorbide Diesters Based Moisturizer on Skin Health', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integrative Skin Science and Research'}, 'officialTitle': 'The Effect of Isosorbide Diesters Based Moisturizer on Skin Health', 'orgStudyIdInfo': {'id': 'I20-ISO1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal', 'description': 'Topical lotion containing isosorbide diesters and colloidal oatmeal to be applied to the entire body once daily.', 'interventionNames': ['Other: Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moisturizer containing colloidal oatmeal', 'description': 'Topical moisturizer with colloidal oatmeal to be applied to the entire body once daily', 'interventionNames': ['Other: Moisturizer containing Colloidal Oatmeal only']}], 'interventions': [{'name': 'Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal', 'type': 'OTHER', 'description': 'Study lotion containing 0.1% colloidal oatmeal along with 4% HydraSynol® DOI (Isosorbide Dicaprylate) and 4% HydraSynol® IDL/(Isosorbide Disunflowerseedate)', 'armGroupLabels': ['Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal']}, {'name': 'Moisturizer containing Colloidal Oatmeal only', 'type': 'OTHER', 'description': 'Vehicle lotion containing 0.1% colloidal oatmeal.', 'armGroupLabels': ['Moisturizer containing colloidal oatmeal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Integrative Skin Science and Research', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integrative Skin Science and Research', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sytheon Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Raja Sivamani, MD MS AP', 'investigatorAffiliation': 'Integrative Skin Science and Research'}}}}