Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
Study NCT ID:
NCT05688735
Status:
UNKNOWN
Last Update Posted:
2023-04-14
First Post:
2023-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind, randomized'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2023-01-09', 'studyFirstSubmitQcDate': '2023-01-09', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eczema Area and Severity Index (EASI)', 'timeFrame': '8 Weeks', 'description': 'Percent Achieving EASI 75'}, {'measure': 'Itch', 'timeFrame': '8 Weeks', 'description': 'Change in the Itch Visual Analog Scale from Baseline'}], 'secondaryOutcomes': [{'measure': 'Eczema Area and Severity Index (EASI)', 'timeFrame': '1 Week', 'description': 'Change in the EASI score'}, {'measure': 'Eczema Area and Severity Index (EASI)', 'timeFrame': '4 Weeks', 'description': 'Change in the EASI score'}, {'measure': 'Eczema Area and Severity Index (EASI)', 'timeFrame': '8 Weeks', 'description': 'Change in the EASI score'}, {'measure': 'Itch', 'timeFrame': '1 Week', 'description': 'Change in the Itch Visual Analog Scale'}, {'measure': 'Itch', 'timeFrame': '4 Weeks', 'description': 'Change in the Itch Visual Analog Scale'}, {'measure': 'Topical steroid use', 'timeFrame': '1 Week', 'description': 'Cumulative use of topical steroid use'}, {'measure': 'Topical steroid use', 'timeFrame': '4 Weeks', 'description': 'Cumulative use of topical steroid use'}, {'measure': 'Topical steroid use', 'timeFrame': '8 Weeks', 'description': 'Cumulative use of topical steroid use'}, {'measure': 'Skin Transepidermal Water Loss (TEWL)', 'timeFrame': '1 Week', 'description': 'TEWL measured with a Vapometer'}, {'measure': 'Skin Transepidermal Water Loss (TEWL)', 'timeFrame': '4 Weeks', 'description': 'TEWL measured with a Vapometer'}, {'measure': 'Skin Transepidermal Water Loss (TEWL)', 'timeFrame': '8 Weeks', 'description': 'TEWL measured with a Vapometer'}, {'measure': 'Skin Hydration', 'timeFrame': '1 week', 'description': 'Level of skin hydration measured SkinMoistureMeterSC'}, {'measure': 'Skin Hydration', 'timeFrame': '4 weeks', 'description': 'Level of skin hydration measured SkinMoistureMeterSC'}, {'measure': 'Skin Hydration', 'timeFrame': '8 weeks', 'description': 'Level of skin hydration measured SkinMoistureMeterSC'}, {'measure': 'Shift in the Skin Microbiome', 'timeFrame': '8 weeks', 'description': 'Change in the relative abundance of Staphylococcus aureus on the skin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare coconut oil and sunflower seed oil derived isosorbide disesters and colloidal oatmeal, and observe their effect on pediatric atopic dermatitis among males and females aged 2-17.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females ages 2-17 years old at the time of consent.\n* Clinical diagnosis of active atopic dermatitis\n* vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of "mild" (2) or "moderate" (3) at Baseline\n* EASI (Eczema Area and Severity Index) score of \\>/= 5 at Baseline\n\nExclusion Criteria:\n\n* Individuals who have a known allergy to isosorbide diesters, coconut oil, or sunflower seed oil\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': 'NCT05688735', 'briefTitle': 'Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integrative Skin Science and Research'}, 'officialTitle': 'Prospective Randomized Vehicle-Controlled, Double-Blind Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal', 'orgStudyIdInfo': {'id': 'IDEAS_PEDS_AD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental Topical Product', 'description': 'Topical moisturizer With Colloidal Oatmeal and Isosorbide Diesters + Topical Steroids', 'interventionNames': ['Other: Isosorbide Diester Moisturizer']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Topical Product', 'description': 'Topical moisturizer With Colloidal Oatmeal WITHOUT Isosorbide Diesters + Topical Steroids', 'interventionNames': ['Other: Control Moisturizer']}], 'interventions': [{'name': 'Isosorbide Diester Moisturizer', 'type': 'OTHER', 'description': 'Isosorbide Diesters (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5% ointment', 'armGroupLabels': ['Experimental Topical Product']}, {'name': 'Control Moisturizer', 'type': 'OTHER', 'description': 'Topical vehicle (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5 % ointment', 'armGroupLabels': ['Control Topical Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Caitlin Dion', 'role': 'CONTACT', 'email': 'caitlin@integrativeskinresearch.com', 'phone': '916-750-2463'}], 'facility': 'Integrative Skin Science and Research', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'centralContacts': [{'name': 'Raja Sivamani, MD', 'role': 'CONTACT', 'email': 'raja.sivamani@integrativeskinresearch.com', 'phone': '(916) 750-2463'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integrative Skin Science and Research', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sytheon Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}