Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT00436527
Status:
COMPLETED
Last Update Posted:
2022-07-29
First Post:
2007-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2007-02-16', 'studyFirstSubmitQcDate': '2007-02-16', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Six replicate Corneometer CM 825 measurements', 'timeFrame': '8 hours'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rosacea']}, 'descriptionModule': {'briefSummary': 'This eight-hour kinetic regression clinical study was conducted to assess the ability of MetroGel® 1% to deliver moisture to facial skin after a single application.', 'detailedDescription': 'This eight-hour kinetic regression clinical study was conducted to assess the ability of MetroGel® 1% to deliver moisture to facial skin after a single application as measured by the Corneometer CM 825.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of moderate to severe rosacea, defined as the presence of at least moderate erythema with telangiectasia and a minimum of two inflammatory lesions\n\nExclusion Criteria:\n\n* Individuals with active symptoms of allergy (mild active seasonal allergies are acceptable) or atopic dermatitis'}, 'identificationModule': {'nctId': 'NCT00436527', 'briefTitle': 'Assess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'MetroGel 1% Hydration Study: A Kinetic Regression Study', 'orgStudyIdInfo': {'id': 'US10041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'interventionNames': ['Drug: Metronidazole gel 1%']}], 'interventions': [{'name': 'Metronidazole gel 1%', 'type': 'DRUG', 'otherNames': ['MetroGel® 1%'], 'description': 'Applied once to a test site on the right or left cheek (as determined by a randomization design)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80915', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Springs Research Center', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}], 'overallOfficials': [{'name': 'Ronald W Gottschalk, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galderma Laboratories, LP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Ronald W. Gottschalk, MD / Medical Director', 'oldOrganization': 'Galderma Laboratories, L.P.'}}}}