Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 11:15 AM
Study NCT ID:
NCT07367932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2025-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Crisaborole vs. Tacrolimus in Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-20', 'studyFirstSubmitDate': '2025-12-28', 'studyFirstSubmitQcDate': '2026-01-20', 'lastUpdatePostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Improvement of Investigator's Static Global Assessment score", 'timeFrame': '3 months', 'description': "1. Assessment of the \\*\\*Investigator's Static Global Assessment\\*\\* scores before and after treatment with crisaborole 2% ointment.\n2. Assessment of the \\*\\*Investigator's Static Global Assessment\\*\\* before and after treatment with tacrolimus 0.03% ointment.\n3. Comparison of the \\*\\*percentage of improvement\\*\\* in the \\*\\*Investigator's Static Global Assessment\\*\\* between the two treatment groups."}, {'measure': 'Improvement of Eczema Area and Severity Index', 'timeFrame': '3 months', 'description': '1. Assessment of \\*\\*Eczema Area and Severity Index\\*\\* scores before and after the use of \\*\\*crisaborole 2% ointment\\*\\*.\n2. Assessment of \\*\\*Eczema Area and Severity Index\\*\\* scores before and after the use of \\*\\*tacrolimus 0.03% ointment\\*\\*.\n3. Comparison of the percentage of improvement in the \\*\\*Eczema Area and Severity Index\\*\\* scores between the two treatment groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tacrolimus', 'Crisaborole', 'Atopic dermatitis'], 'conditions': ['Dermatitis, Atopic', 'Eczema']}, 'descriptionModule': {'briefSummary': 'This study will compare the efficacy and safety of crisaborole ointment with tacrolimus ointment, in the treatment of patients with mild-to-moderate atopic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with diagnosis of AD, according to Hanifin and Rajka criteria.\n* Patients of both genders\n* Age 5-25 years\n* Baseline Investigator's Static Global Assessment (ISGA) score of mild (2) or moderate (3).\n\nExclusion Criteria:\n\n* Clinically infected eczema.\n* Baseline Investigator's Static Global Assessment (ISGA) score of severe (4).\n* Associated comorbidities that exacerbate pruritus.\n* Patients receiving topical treatment for AD and/or pruritus within the past 14 days and/or systemic treatment within the past month.\n* Pregnancy and lactation if in the childbearing period"}, 'identificationModule': {'nctId': 'NCT07367932', 'briefTitle': 'Comparative Study of Crisaborole vs. Tacrolimus in Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Crisaborole 2% Versus Tacrolimus 0.03% Ointments for the Treatment of Mild to Moderate Atopic Dermatitis: A Comparative Study', 'orgStudyIdInfo': {'id': 'MS-61-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Crisaborole ointment', 'interventionNames': ['Drug: Application of crisaborole twice daily']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tacrolimus ointment', 'interventionNames': ['Drug: Tacrolimus ointment in atopic dermatitis']}], 'interventions': [{'name': 'Application of crisaborole twice daily', 'type': 'DRUG', 'description': 'compare the efficacy and safety of crisaborole ointment on mild to moderate atopic dermatitis for 1 month and followup in 2 months', 'armGroupLabels': ['Crisaborole ointment']}, {'name': 'Tacrolimus ointment in atopic dermatitis', 'type': 'DRUG', 'description': 'compare the efficacy and safety of tacrolimus ointment, in the treatment of patients with mild-to-moderate atopic dermatitis', 'armGroupLabels': ['Tacrolimus ointment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aya Raafat Khalil, MBBcH', 'role': 'CONTACT', 'email': 'ayah.rafaat.97@gmail.com', 'phone': '+201120807903'}, {'name': 'Rana Ahmed Mosaad, MD', 'role': 'CONTACT', 'email': 'ranaahmedmosaad@gmail.com', 'phone': '+201096344429'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Amira Elbendary', 'investigatorAffiliation': 'Cairo University'}}}}