Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-29 @ 6:54 AM
Study NCT ID:
NCT01186068
Status:
COMPLETED
Last Update Posted:
2010-11-24
First Post:
2010-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Response Study of Patients With Erythematous Rosacea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}, {'id': 'D004890', 'term': 'Erythema'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'lastUpdateSubmitDate': '2010-11-22', 'studyFirstSubmitDate': '2010-08-17', 'studyFirstSubmitQcDate': '2010-08-19', 'lastUpdatePostDateStruct': {'date': '2010-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Clinician's Erythema Assessment", 'timeFrame': 'Day 28 visit', 'description': 'Physician visual evaluation'}], 'secondaryOutcomes': [{'measure': "Subject's Self Assessment", 'timeFrame': '28 Day Visit', 'description': 'Patient assesses their condition'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rosacea, erythema'], 'conditions': ['Erythematous (Type One) Rosacea']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the dose-response relationship (effect) of four concentrations of V-101 Cream in patients with erythematous(redness) rosacea.', 'detailedDescription': 'Patients must have moderate to severe erythematous (facial redness) rosacea\n\n* Male and female patients must be at least 18 years old and in good general health\n* Female patients must not be pregnant or nursing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or females at least 18 years of age\n* diagnosis of stable erythematous rosacea\n* \\< 3 inflammatory lesions\n* in good general health\n* females must be non-pregnant and non-lactating\n* must be willing to sign a consent form\n\nExclusion Criteria:\n\n* have ocular, phymatous or other types of rosacea\n* allergy to any ingredient in study drug\n* participation in other investigational studies within 30 days of enrollment\n* use of systemic steroids within 28 days of Baseline\n* use of tetracycline antibiotics within 28 days of baseline\n* use of products containing oxymetazoline within 14 days of baseline\n* use of topical steroids witin treatment area 14 days prior to baseline\n* use of Rx or OTC products for treatment of acne or rosacea within 14 days of baseline\n* use of any product for reducing redness within the treatment area witin 14 days prior to baseline\n* use of monoamine oxidase (MAO) inhibitors\n* use of niacin \\>/= 500mg/day'}, 'identificationModule': {'nctId': 'NCT01186068', 'briefTitle': 'Dose Response Study of Patients With Erythematous Rosacea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vicept Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of the Dose-Response Profile of V-101 Cream in Subjects With Erythematous Rosacea', 'orgStudyIdInfo': {'id': 'V-101-ROSE-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V-101 Cream 0.01% Concentration', 'description': 'Low dose', 'interventionNames': ['Drug: V-101']}, {'type': 'EXPERIMENTAL', 'label': 'V-101 Cream 0.06% Concentration', 'description': 'Mid-dose', 'interventionNames': ['Drug: V-101']}, {'type': 'EXPERIMENTAL', 'label': 'V-101 Cream 0.1% Concentration', 'description': 'Mid-dose', 'interventionNames': ['Drug: V-101']}, {'type': 'EXPERIMENTAL', 'label': 'V-101 Cream 0.15% Concentration', 'description': 'High dose', 'interventionNames': ['Drug: V-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Cream without an active ingredient', 'interventionNames': ['Other: vehicle']}], 'interventions': [{'name': 'V-101', 'type': 'DRUG', 'description': 'Cream QD', 'armGroupLabels': ['V-101 Cream 0.01% Concentration', 'V-101 Cream 0.06% Concentration', 'V-101 Cream 0.1% Concentration', 'V-101 Cream 0.15% Concentration']}, {'name': 'vehicle', 'type': 'OTHER', 'description': 'Cream QD', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Therapeutics Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Baumann Cosmetic & Research Institute', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Dermatology Specialists Research', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48038', 'city': 'Clinton Twp', 'state': 'Michigan', 'country': 'United States', 'facility': 'DBA Michigan Center for Skin Care Research'}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Academic Dermatology Associates', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '97223', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Medical Research Center, PC', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Stacy R Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Therapeutics Clinical Research'}, {'name': 'Michael T Jarratt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Derm Research, PLLC'}, {'name': 'Leslie S Baumann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baumann Cosmetic & Research Institute'}, {'name': 'Joseph F Fowler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology Specialists Research'}, {'name': 'Robert T Matheson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Medical Research Center, PC'}, {'name': 'Daniel M Stewart, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DBA Michigan Center for Skin Care Research'}, {'name': 'Eduardo Tschen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academic Dermatology Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vicept Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Accenture', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Chief Operating Officer', 'oldOrganization': 'Vicept Therapeutics, Inc.'}}}}