Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-02-11 @ 9:48 AM
Study NCT ID:
NCT02426359
Status:
COMPLETED
Last Update Posted:
2016-12-06
First Post:
2015-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Q301 in Moderate to Severe Atopic Dermatitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-03', 'studyFirstSubmitDate': '2015-04-21', 'studyFirstSubmitQcDate': '2015-04-23', 'lastUpdatePostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients who have the IGA score of 0 or 1', 'timeFrame': 'Week 8'}], 'secondaryOutcomes': [{'measure': 'Percent change from baseline on the VAS for pruritus', 'timeFrame': 'Week 8'}, {'measure': 'Percent change from baseline on the EASI', 'timeFrame': 'Week 8'}, {'measure': 'Percent change from baseline on the SCORAD', 'timeFrame': 'Week 8'}, {'measure': 'Percent change from baseline on the DLQI', 'timeFrame': 'Week 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Moderate to Severe Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to evaluate the safety and efficacy of Q301 Cream vs. vehicle in adult subjects with moderate to severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects aged 18 or older\n2. Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist\n3. Subjects with IGA score 3 or 4 corresponding to moderate to severe AD at screening and baseline visits\n\nExclusion Criteria:\n\n1. Subjects who had topical treatment with corticosteroids within 1 week before randomization\n2. Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatment within 4 weeks before randomization\n3. Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks before screening\n4. Subjects who participated in another drug trial within 4 weeks before screening'}, 'identificationModule': {'nctId': 'NCT02426359', 'briefTitle': 'Safety and Efficacy Study of Q301 in Moderate to Severe Atopic Dermatitis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qurient Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'Q301-ADP2-US-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Q301 Cream', 'description': 'Q301 Cream', 'interventionNames': ['Drug: Q301 Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Vehicle', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Q301 Cream', 'type': 'DRUG', 'armGroupLabels': ['Q301 Cream']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '08520', 'city': 'East Windsor', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.268, 'lon': -74.54043}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77845', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qurient Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}