Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-23 @ 6:24 AM
Study NCT ID:
NCT02227069
Status:
COMPLETED
Last Update Posted:
2015-03-30
First Post:
2014-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012967', 'term': 'Sodium Dodecyl Sulfate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D007851', 'term': 'Dodecanol'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-27', 'studyFirstSubmitDate': '2014-08-21', 'studyFirstSubmitQcDate': '2014-08-25', 'lastUpdatePostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammatory skin responses', 'timeFrame': '21 Days', 'description': 'Drug application sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a single center, randomized, controlled, within-subject comparison, multiple dose study to determine the irritation potential of M518101 on normal skin under occlusive patch condition.\n\nThe study drug will be applied for 21 days under occlusive patch condition. The irritation potential of M518101 will be compared with positive, negative control and M518101 vehicle. The study duration is 21days and there will be at least 23 visits to study center including screening visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Health male or female subjects age 18 years or older\n* Signed and dated Informed Consent Form obtained prior to any study-related activities\n* Subjects are free of any systemic or dermatologic disorder\n* For Female, females of non-childbearing potential or who agree to use a highly effective method of birth control during the study and have a negative urine pregnancy test.\n* Subjects must be able to communicate with the investigator and understand and comply with the requirements of the study and visit schedule\n\nExclusion Criteria:\n\n* Have any visible skin disease at the application site which will interfere with the evaluation of the test site reaction\n* Have damaged skin in or around the test sites\n* Have a history of sensitivity to adhesive tape\n* Have a known sensitivity to constituents present in the material being evaluated\n* Have a history of, or are currently being treated for skin cancer\n* have used any study drug and/or participate in any clinical study within 60 days prior to Randomization\n* to engage in any type of strenuous exercise (swimming, running, etc.) or who intended to use hot tubs or saunas during the study\n* Are pregnant, breastfeeding, or of childbearing potential and who wish to become pregnant during the study\n* Are deemed to be ineligible by the investigator'}, 'identificationModule': {'nctId': 'NCT02227069', 'briefTitle': 'Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Maruho North America Inc.'}, 'officialTitle': 'A Phase 1, 21-Day, Randomized, Evaluator Blinded, Controlled Study to Evaluate the Irritation Potential of M518101 in Healthy Volunteers, Using a Cumulative Irritant Patch Test Design', 'orgStudyIdInfo': {'id': 'M518101-US06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'M518101', 'description': 'M518101 is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks', 'interventionNames': ['Drug: M518101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'M518101 Vehicle', 'description': 'M518101 vehicle is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks', 'interventionNames': ['Drug: M518101 Vehicle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sodium lauryl sulfate', 'description': 'A solution of 0.2% sodium lauryl sulfate is applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a positive control.', 'interventionNames': ['Other: sodium lauryl sulfate']}, {'type': 'SHAM_COMPARATOR', 'label': 'Saline', 'description': 'A solution of 0.9% saline is applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a negative control.', 'interventionNames': ['Other: saline']}], 'interventions': [{'name': 'M518101', 'type': 'DRUG', 'armGroupLabels': ['M518101']}, {'name': 'M518101 Vehicle', 'type': 'DRUG', 'armGroupLabels': ['M518101 Vehicle']}, {'name': 'sodium lauryl sulfate', 'type': 'OTHER', 'armGroupLabels': ['sodium lauryl sulfate']}, {'name': 'saline', 'type': 'OTHER', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07410', 'city': 'Fair Lawn', 'state': 'New Jersey', 'country': 'United States', 'facility': 'TKL research', 'geoPoint': {'lat': 40.94038, 'lon': -74.13181}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maruho North America Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}