Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-28 @ 9:55 AM
Study NCT ID:
NCT07113366
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Jelly Fig (Ficus Awkeotsang Makino) Extract for Atopic Dermatitis
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2025-08-04', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Proportion of Participants Achieving Investigator's Global Assessment (IGA) Success", 'timeFrame': 'Day 28', 'description': 'IGA success is defined as achieving a score of 0 (clear) or 1 (almost clear) with a ≥2-point improvement from baseline on the 5-point IGA scale. The scale ranges from 0 (clear) to 4 (severe), with lower scores indicating less disease severity.\n\nUnit of Measure: Percentage of participants (%)'}], 'secondaryOutcomes': [{'measure': 'Change in Eczema Area and Severity Index (EASI) Score from Baseline to Days 7 and 28', 'timeFrame': 'Baseline, Day 7, and Day 28', 'description': 'The EASI score ranges from 0 to 72, with higher scores indicating more severe disease. This outcome measures the change in EASI score from baseline.\n\nUnit of Measure: Units on a scale'}, {'measure': 'Change in Peak Pruritus Numerical Rating Scale (pp-NRS) Score from Baseline to Days 7 and 28', 'timeFrame': 'Baseline, Day 7, and Day 28', 'description': 'The pp-NRS is an 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Participants rate their worst itch over the past 24 hours.\n\nUnit of Measure: Units on a scale'}, {'measure': 'Change in Body Surface Area (BSA) Affected by Atopic Dermatitis from Baseline to Days 7 and 28', 'timeFrame': 'Baseline, Day 7, and Day 28', 'description': 'This outcome measures the percentage of body surface area affected by atopic dermatitis.\n\nUnit of Measure: Percent (%)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis (AD)']}, 'descriptionModule': {'briefSummary': 'The study is designed to evaluate the efficacy and safety of a topical formulation containing Ficus awkeotsang Makino extract (FAE), derived from jelly fig, in participants with mild to moderate atopic dermatitis. Ficus awkeotsang is a traditional plant native to Taiwan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥12 years at the time of enrollment\n* Clinical diagnosis of atopic dermatitis (AD) according to the Hanifin and Rajka criteria\n* Investigator's Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at screening\n\nExclusion Criteria:\n\n* Prior treatment with biologic agents within 16 weeks before baseline\n* Use of phototherapy, systemic corticosteroids, or other systemic immunosuppressants within 28 days before baseline\n* Use of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 14 days before baseline\n* Presence of active skin infections\n* Pregnancy or breastfeeding\n* Known hypersensitivity to any component of the investigational product"}, 'identificationModule': {'nctId': 'NCT07113366', 'briefTitle': 'Efficacy of Jelly Fig (Ficus Awkeotsang Makino) Extract for Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Veterans General Hospital.'}, 'officialTitle': 'Improvement of Atopic Dermatitis Symptoms and Signs by Jelly Fig (Ficus Awkeotsang Makino) Extract', 'orgStudyIdInfo': {'id': 'KSVGH24-CT3-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High-dose FAE cream (5.0 mg/mL)', 'description': 'Ficus awkeotsang Makino extract (FAE)', 'interventionNames': ['Drug: FAE cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low- dose FAE cream (1.0 mg/mL)', 'description': 'Ficus awkeotsang Makino extract (FAE)', 'interventionNames': ['Drug: FAE cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'FAE cream', 'type': 'DRUG', 'description': 'Ficus awkeotsang Makino extract (FAE)', 'armGroupLabels': ['High-dose FAE cream (5.0 mg/mL)', 'Low- dose FAE cream (1.0 mg/mL)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '813414', 'city': 'Kaohsiung City', 'state': 'Kaohsiung', 'country': 'Taiwan', 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Veterans General Hospital.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Dermatology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.', 'investigatorFullName': 'Chiau-Sheng Jang', 'investigatorAffiliation': 'Kaohsiung Veterans General Hospital.'}}}}