Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-03 @ 10:05 AM
Study NCT ID:
NCT02949960
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2016-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DMT210 Topical Gel in the Treatment of 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'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}], 'ancestors': [{'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}]}}, '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': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-17', 'studyFirstSubmitDate': '2016-10-27', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of adverse events as a measure of safety and tolerability', 'timeFrame': 'Day 28'}], 'primaryOutcomes': [{'measure': 'ADSI (Atopic Dermatitis Severity Index) score of each Target lesion', 'timeFrame': 'Day 28', 'description': 'Change from baseline in ADSI score between Vehicle and 5% gel'}], 'secondaryOutcomes': [{'measure': 'Individual Signs and Symptoms of Atopic Dermatitis of each Target Lesion', 'timeFrame': 'Day 28', 'description': 'Change from baseline in AD symptom scores between Vehicle and 5% gel'}, {'measure': 'Investigator Global Assessment (IGA) of the Treatment Area', 'timeFrame': 'Day 28'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Eczema', 'Dermatitis', 'Skin Diseases', 'Skin Diseases, Genetic', 'Dermatitis, Atopic', 'Skin Diseases, Eczematous', 'Hypersensitivity', 'Immune System Diseases'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the safety and efficacy of DMT210 Gel, 5% compared to vehicle control following 28 days of twice-daily topical application to selected target lesions in male and female patients with mild to moderate atopic dermatitis (AD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 12 years or older\n* Patient has chronic, stable AD that has been present for at least 3 months with 5-35% (inclusive) BSA (Body Surface Area) of AD involvement\n* Patient has two analogous, Target Lesions; one lesion within each of the two Treatment Areas\n* Patient is willing and able to comply with the protocol\n\nExclusion Criteria:\n\n* Patient has used topical therapies for AD within the Treatment Areas 2 weeks before baseline'}, 'identificationModule': {'nctId': 'NCT02949960', 'briefTitle': 'DMT210 Topical Gel in the Treatment of Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dermata Therapeutics'}, 'officialTitle': 'DMT210 Topical Gel in the Treatment of Mild to Moderate Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'DMT210-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DMT210 Topical Gel', 'description': 'DMT210 Topical Gel 5% applied to target lesion twice daily', 'interventionNames': ['Drug: DMT210 Topical Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Control', 'description': 'Topical Gel vehicle applied to target lesion twice daily', 'interventionNames': ['Drug: Vehicle Control']}], 'interventions': [{'name': 'DMT210 Topical Gel', 'type': 'DRUG', 'description': 'DMT210 Topical Aqueous Gel 5% applied twice daily', 'armGroupLabels': ['DMT210 Topical Gel']}, {'name': 'Vehicle Control', 'type': 'DRUG', 'description': 'Topical Vehicle Gel applied twice daily', 'armGroupLabels': ['Vehicle Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77056', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermata Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Dermata Investigational Site', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Christopher Nardo, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dermata Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dermata Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}