Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
Study NCT ID:
NCT06998056
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2025-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm open label study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-05-05', 'studyFirstSubmitQcDate': '2025-05-28', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject incidence of adverse events', 'timeFrame': '4 weeks', 'description': 'Number of participants with adverse events during treatment will be assessed'}, {'measure': 'Subject incidence of serious adverse events', 'timeFrame': '4 weeks', 'description': 'Number of participants with serious adverse events during treatment will be assessed'}, {'measure': 'Incidence of application site reactions', 'timeFrame': '4 weeks', 'description': 'Number of subjects that experience an application site skin reaction by investigator assessment and application site reactions reported as adverse events will be assessed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atopic dermatitis', 'eczema'], 'conditions': ['Atopic Dermatitis (Eczema)']}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and tolerability of ARQ-151 cream 0.05% applied once a day for 4 weeks in infants with atopic dermatitis (eczema).', 'detailedDescription': 'This study is an open label safety study in which ARQ-151 cream 0.05% is applied once a day for 4 weeks in infants with atopic dermatitis (eczema).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Informed consent of a parent(s) or legal guardian(s), as required by local laws.\n2. Males and females, ages 3 months to \\<2 years old at Day 1.\n3. Diagnosed with mild to moderate Atopic Dermatitis (AD) for at least 1 month duration prior to or at the screening visit.\n4. Has AD involvement of ≥3% BSA at Day1.\n5. In good health as judged by the Investigator\n6. Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.\n\nExclusion Criteria:\n\n1. Subjects with any serious medical condition, clinically significant vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.\n2. Subjects who have unstable AD or any consistent requirement for high potency topical steroids to manage AD signs or symptoms.\n3. Subjects previously treated with ARQ-151\n4. Subjects currently undergoing allergy testing or food challenges, or plan to do so during the study.\n5. Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language. Subjects who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.\n6. Subjects who are family members of the clinical study staff or sponsor."}, 'identificationModule': {'nctId': 'NCT06998056', 'briefTitle': 'Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arcutis Biotherapeutics, Inc.'}, 'officialTitle': 'A Phase 2, Open Label, 4-Week, Safety Study of Roflumilast Cream 0.05% Administered Once Daily in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'ARQ-151-218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARQ-151 roflumilast cream 0.05% (open label)', 'description': 'This single study arm is open label in which ARQ-151 cream 0.05% is applied daily for 4 weeks.', 'interventionNames': ['Drug: ARQ-151 cream 0.05%']}], 'interventions': [{'name': 'ARQ-151 cream 0.05%', 'type': 'DRUG', 'description': 'ARQ-151 Cream 0.05% is applied once daily for 4 weeks in infants with atopic dermatitis (eczema).', 'armGroupLabels': ['ARQ-151 roflumilast cream 0.05% (open label)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 208', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72022', 'city': 'Bryant', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 221', 'geoPoint': {'lat': 34.59593, 'lon': -92.48905}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 214', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92688', 'city': 'Rancho Santa Margarita', 'state': 'California', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 209', 'geoPoint': {'lat': 33.64086, 'lon': -117.6031}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 207', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33484', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 217', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 213', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 223', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '47906', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 219', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}, {'zip': '55112', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 212', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '03801', 'city': 'Portsmouth', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 211', 'geoPoint': {'lat': 43.07704, 'lon': -70.75766}}, {'zip': '45040', 'city': 'Mason', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 220', 'geoPoint': {'lat': 39.36006, 'lon': -84.30994}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 206', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29486', 'city': 'Summerville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 222', 'geoPoint': {'lat': 33.0185, 'lon': -80.17565}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 210', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '76244', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 224', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78218', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Arcutis Clinical Study Site 202', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': 'R3J0S9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Arcutis Clinical Study Site 203', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'B3K 5R3', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Arcutis Clinical Study Site 204', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'N2J1C4', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arcutis Clinical Study Site 216', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': 'S7K2C1', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Arcutis Clinical Study Site 225', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': '10306', 'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Arcutis Clinical Study Site 201', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arcutis Biotherapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}