Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-03-26 @ 11:13 PM
Study NCT ID:
NCT03003104
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2016-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DMT210 Topical Gel in the Treatment of Acne Rosacea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}, {'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-17', 'studyFirstSubmitDate': '2016-12-20', 'studyFirstSubmitQcDate': '2016-12-21', 'lastUpdatePostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy as measured by Inflammatory lesion counts', 'timeFrame': '12 weeks', 'description': 'Inflammatory lesion counts'}, {'measure': 'Efficacy as measured by Investigator Global Assessment (IGA)', 'timeFrame': '12 weeks', 'description': 'Investigator Global Assessment (IGA)'}, {'measure': 'Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)', 'timeFrame': '12 weeks', 'description': '5-point Clinical Erythema Assessment (CEA)'}, {'measure': 'Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)', 'timeFrame': '12 weeks', 'description': '5-point Patient Severity Assessment of Erythema (PSA)'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events as a measure of safety and tolerability', 'timeFrame': '12 weeks', 'description': 'Incidence of adverse events as a measure of safety and tolerability'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Skin diseases', 'rosacea'], 'conditions': ['Acne Rosacea']}, 'descriptionModule': {'briefSummary': 'The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is male or non-pregnant female at least 18 years of age.\n* Clinical diagnosis of moderate to severe facial rosacea as determined by Investigator's Global Assessment (IGA) at Randomization\n* Patient has at least ten inflammatory lesions of rosacea on the face at Randomization\n* Patient is willing to apply the Investigational Product as directed\n* Patient is willing and able to comply with the protocol\n\nExclusion Criteria:\n\n* Patient is pregnant or planning to become pregnant\n* Patient is taking a topical therapy which may affect the patient's rosacea"}, 'identificationModule': {'nctId': 'NCT03003104', 'briefTitle': 'DMT210 Topical Gel in the Treatment of Acne Rosacea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dermata Therapeutics'}, 'officialTitle': 'A Randomized, Double-Blind, Vehicle Controlled Study To Evaluate The Safety, Tolerability, And Efficacy Of DMT210 Gel In Adult Patients With Moderate To Severe Acne Rosacea', 'orgStudyIdInfo': {'id': 'DMT210-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DMT210 Topical Gel', 'description': 'DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks', 'interventionNames': ['Drug: DMT210 Topical Gel 5%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Control', 'description': 'Topical Gel vehicle applied to the face twice daily for 12 weeks', 'interventionNames': ['Other: Vehicle Control']}], 'interventions': [{'name': 'DMT210 Topical Gel 5%', 'type': 'DRUG', 'armGroupLabels': ['DMT210 Topical Gel']}, {'name': 'Vehicle Control', 'type': 'OTHER', 'armGroupLabels': ['Vehicle Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Dermata Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Dermata Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Dermata Investigational Site', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Dermata Investigational Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermata Investigational Site', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'city': 'Broomall', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Dermata Investigational Site', 'geoPoint': {'lat': 39.9815, 'lon': -75.35658}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Dermata Investigational Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermata Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Dermata Investigational Site', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dermata Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}