Ignite Creation Date:
2025-12-24 @ 6:46 PM
Ignite Modification Date:
2026-01-27 @ 9:46 AM
Study NCT ID:
NCT03375957
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2017-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensitization Study of ATx201 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003877', 'term': 'Dermatitis, Contact'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2017-12-12', 'studyFirstSubmitQcDate': '2017-12-15', 'lastUpdatePostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dermal Response Score', 'timeFrame': '21 days', 'description': 'number of patients with a dermal response score of at least 2'}], 'secondaryOutcomes': [{'measure': 'Dermal Response and Effects Score', 'timeFrame': '21 days', 'description': 'number of patients with a dermal response and effects score of at least 3'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sensitivity, Contact']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, single-site study to evaluate the sensitization potential of topically applied ATx201 GEL, 2% and 4%, along with a placebo control, in healthy human subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good general health\n* Body Mass Index no less than 19.0 and no greater than 36.0 kg/m² (inclusive).\n* Demonstrates a Fitzpatrick skin score of I - IV\n* Female subjects must agree to use acceptable contraceptive methods from the Screening Visit through 90 days after the End of Study (EOS) Visit; or postmenopausal status with no menses for at least 1 year prior to the Screening Visit.\n* Willing to refrain from excessive consumption of sodium in food or beverage 48 hours prior to Day 1 through EOS Visit.\n* Willing to shower using the same non-medicated soap/cleansers, and abstain from excessive sun exposure (including tanning salons) from the Screening Visit through EOS Visit.\n\nExclusion Criteria:\n\n* Reports a history of diabetes mellitus, clinically significant asthma (acceptable if no episode within 5 years prior to Day 1), or currently diagnosed with hypertension or circulatory disease.\n* Reports use of any oral, nasal or topical corticosteroids, or oral or topical retinoids (other than Vitamin A at normal dietary amounts)\n* Reports a significant history of allergy to soaps, lotions, emollients, ointments, creams, cosmetics, adhesives, or latex.\n* Reports a history of significant skin conditions or disorders such as psoriasis, atopic dermatitis, etc.\n* Reports a history of significant dermatologic cancers.\n* Displays an obvious difference in skin color between upper arms or upper back or the presence of a skin anomaly\n* Reports smoking or use of tobacco or nicotine delivery products within 14 days prior to Day 1 through EOS Visit.\n* Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator.\n* A female who is pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study.\n* Reports a history of drug or alcohol addiction or abuse within the past year.\n* Reports having donated blood or plasma within 48 hours prior to Day 1 through EOS Visit.\n* Subject exhibits excessive hair density on the upper arms or back such that patch adhesion could be compromised.\n* Subject reports undergoing hair depilation (e.g. chemical, laser, physical) within 30 days prior to Day 1 through EOS Visit.'}, 'identificationModule': {'nctId': 'NCT03375957', 'briefTitle': 'Sensitization Study of ATx201 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'UNION therapeutics'}, 'officialTitle': 'A Single-Site Study To Evaluate the Sensitization Potential of Topically Applied ATx201 in Healthy Human Volunteers', 'orgStudyIdInfo': {'id': 'ATx201-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ATx201 2% Gel', 'interventionNames': ['Drug: ATx201']}, {'type': 'EXPERIMENTAL', 'label': 'ATx201 4% Gel', 'interventionNames': ['Drug: ATx201']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ATx201 Gel Placebo', 'interventionNames': ['Drug: ATx201 Placebo Gel']}], 'interventions': [{'name': 'ATx201', 'type': 'DRUG', 'description': 'two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms', 'armGroupLabels': ['ATx201 2% Gel', 'ATx201 4% Gel']}, {'name': 'ATx201 Placebo Gel', 'type': 'DRUG', 'description': 'two hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms', 'armGroupLabels': ['ATx201 Gel Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65802', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Bio-Kinetic Clinical Applications, LLC', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}], 'overallOfficials': [{'name': 'Philippe Prokocimer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CMO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNION therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}