Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT03048058
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2017-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Internet Surveys and Their Impact on Adherence for Rosacea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D000068438', 'term': 'Brimonidine Tartrate'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'irichard@wakehealth.edu', 'phone': '336-716-2903', 'title': 'Irma M. RIchardson, MHA;', 'organization': 'Wake Forest University Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations: small sample size (n=20) and poor subject retention. With limited patient data, particularly due to loss of patient follow up, the power of the study was less than ideal.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Brimonidine Topical Gel 0.33% & Survey', 'description': 'brimonidine topical gel 0.33% \\& survey adverse events', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Brimonidine Topical Gel 0.33% & SOC', 'description': 'Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brimonidine Topical Gel 0.33% & Survey', 'description': 'Topical drug and standard of care follow-up,with weekly survey.'}, {'id': 'OG001', 'title': 'Brimonidine Topical Gel 0.33% & SOC', 'description': 'Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits\n\nbrimonidine topical gel 0.33% \\& SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'To assess adherence to topical brimonidine for the treatment of rosacea as measured by MEMS caps. The result will be the % of prescribed doses that were actually taken by the subject', 'unitOfMeasure': 'percentage of medication use', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lesion Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brimonidine Topical Gel 0.33% & Survey', 'description': 'Topical drug and standard of care follow-up,with weekly survey.'}, {'id': 'OG001', 'title': 'Brimonidine Topical Gel 0.33% & SOC', 'description': 'Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits\n\nbrimonidine topical gel 0.33% \\& SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '17.6', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '6.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Change in total Lesion count', 'unitOfMeasure': 'count of lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months'}, {'type': 'SECONDARY', 'title': 'Clinician Erythema Assessment Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brimonidine Topical Gel 0.33% & Survey', 'description': 'Topical drug and standard of care follow-up,with weekly survey.'}, {'id': 'OG001', 'title': 'Brimonidine Topical Gel 0.33% & SOC', 'description': 'Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits\n\nbrimonidine topical gel 0.33% \\& SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '.53', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 months', 'description': 'Clinician Erythema Assessment scale based on scale of 0-4 with 0 being no erythema and 4 being severe erythema with greater scores denoting a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months'}, {'type': 'SECONDARY', 'title': 'Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brimonidine Topical Gel 0.33% & Survey', 'description': 'Topical drug and standard of care follow-up,with weekly survey.'}, {'id': 'OG001', 'title': 'Brimonidine Topical Gel 0.33% & SOC', 'description': 'Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits\n\nbrimonidine topical gel 0.33% \\& SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '8.66', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.43', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 months', 'description': 'Change in overall Quality of Life as measured by the The Life Impact Survey. This measures the impact of rosacea and its treatment on life. The score range is 0-54 with higher scores denoting worse outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months'}, {'type': 'SECONDARY', 'title': 'Patient Severity Assessment (PSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brimonidine Topical Gel 0.33% & Survey', 'description': 'Topical drug and standard of care follow-up,with weekly survey.'}, {'id': 'OG001', 'title': 'Brimonidine Topical Gel 0.33% & SOC', 'description': 'Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits\n\nbrimonidine topical gel 0.33% \\& SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.26', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.14', 'spread': '.9', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 months', 'description': 'Patient Severity Assessment: Subject ratings of erythema with scale 0 - 4. 0 = face free of rosacea; 4 = My face has severe medium to large sized red inflamed bumps or pustules, My face has severe redness. Higher scores denotes worse outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months'}, {'type': 'SECONDARY', 'title': 'Quality of Life With Rosacea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brimonidine Topical Gel 0.33% & Survey', 'description': 'Topical drug and standard of care follow-up,with weekly survey.'}, {'id': 'OG001', 'title': 'Brimonidine Topical Gel 0.33% & SOC', 'description': 'Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits\n\nbrimonidine topical gel 0.33% \\& SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.5', 'spread': '4.25', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '4.79', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.57', 'spread': '4.35', 'groupId': 'OG000'}, {'value': '13', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 months', 'description': 'Quality of life for rosacea was reported. The score range is 4-40 with higher scores denoting worse outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months'}, {'type': 'SECONDARY', 'title': 'Dermatology Life Quality Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brimonidine Topical Gel 0.33% & Survey', 'description': 'Topical drug and standard of care follow-up,with weekly survey.'}, {'id': 'OG001', 'title': 'Brimonidine Topical Gel 0.33% & SOC', 'description': 'Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits\n\nbrimonidine topical gel 0.33% \\& SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%'}], 'timeFrame': 'baseline and 6 months', 'description': "Dermatology Life Quality Index (DLQI) for the impact of rosacea on everyday activities. The score range is 0-30 with higher scores having a larger effect on patient's life.", 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brimonidine Topical Gel 0.33% & Survey', 'description': 'The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication, as well as any additional side effects they may be having from the medication.\n\nbrimonidine topical gel 0.33% \\& survey: The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication,'}, {'id': 'FG001', 'title': 'Brimonidine Topical Gel 0.33% & SOC', 'description': 'Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits\n\nbrimonidine topical gel 0.33% \\& SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': '20 subjects male/female aged 18 years and older with the diagnosis of persistent erythema associated with mild to moderate rosacea as defined by an Investigator Global Assessment rating between 2 and 5. Patients were recruited from Wake Forest University Department of Dermatology Clinics and via Institutional Review Board approved advertising.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Brimonidine Topical Gel 0.33% & Survey', 'description': 'The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication, as well as any additional side effects they may be having from the medication.\n\nbrimonidine topical gel 0.33% \\& survey: The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication,'}, {'id': 'BG001', 'title': 'Brimonidine Topical Gel 0.33% & SOC', 'description': 'Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits\n\nbrimonidine topical gel 0.33% \\& SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33%'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Gender not collected for all participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '20 subjects of both genders aged 18 years and older with the diagnosis of persistent erythema associated with mild to moderate rosacea as defined by an Investigator Global Assessment rating between 2 and 5.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-14', 'size': 1330462, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-06-26T15:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2017-02-06', 'resultsFirstSubmitDate': '2018-06-29', 'studyFirstSubmitQcDate': '2017-02-08', 'lastUpdatePostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-16', 'studyFirstPostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)', 'timeFrame': '6 months', 'description': 'To assess adherence to topical brimonidine for the treatment of rosacea as measured by MEMS caps. The result will be the % of prescribed doses that were actually taken by the subject'}], 'secondaryOutcomes': [{'measure': 'Lesion Count', 'timeFrame': 'Baseline and 6 months', 'description': 'Change in total Lesion count'}, {'measure': 'Clinician Erythema Assessment Scale', 'timeFrame': 'baseline and 6 months', 'description': 'Clinician Erythema Assessment scale based on scale of 0-4 with 0 being no erythema and 4 being severe erythema with greater scores denoting a worse outcome.'}, {'measure': 'Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities)', 'timeFrame': 'baseline and 6 months', 'description': 'Change in overall Quality of Life as measured by the The Life Impact Survey. This measures the impact of rosacea and its treatment on life. The score range is 0-54 with higher scores denoting worse outcomes.'}, {'measure': 'Patient Severity Assessment (PSA)', 'timeFrame': 'baseline and 6 months', 'description': 'Patient Severity Assessment: Subject ratings of erythema with scale 0 - 4. 0 = face free of rosacea; 4 = My face has severe medium to large sized red inflamed bumps or pustules, My face has severe redness. Higher scores denotes worse outcomes.'}, {'measure': 'Quality of Life With Rosacea', 'timeFrame': 'baseline and 6 months', 'description': 'Quality of life for rosacea was reported. The score range is 4-40 with higher scores denoting worse outcomes.'}, {'measure': 'Dermatology Life Quality Index', 'timeFrame': 'baseline and 6 months', 'description': "Dermatology Life Quality Index (DLQI) for the impact of rosacea on everyday activities. The score range is 0-30 with higher scores having a larger effect on patient's life."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rosacea']}, 'descriptionModule': {'briefSummary': 'An investigator-blinded, prospective, 6 month study of subjects with persistent erythema associated with active rosacea will be conducted in 20 subjects aged 18 years and older. All subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to apply it once daily per package insert. Adherence will be assessed using weekly internet surveys to document how often the medication is being used, as well as reminders about rosacea triggers and general use of brimonidine.', 'detailedDescription': "An investigator-blinded, prospective, 6 month study of subjects with persistent erythema associated with active rosacea will be conducted in 20 subjects aged 18 years and older. All subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to apply it once daily per package insert. Adherence will be assessed using weekly internet surveys to document how often the medication is being used, as well as reminders about rosacea triggers and general use of brimonidine.Subjects will be randomized 1:1 to be in the weekly internet survey group or the standard care non-survey group.\n\nAt each visit, review of the internet survey use will be done to assess adherence to the medication. . Disease severity measures ((Clinician's Erythema Assessment (CEA), and Lesion counts will be obtained. QOL will be measured."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subject with persistent erythema associated with rosacea, age greater than 18, who agrees to participate and provide written consent.\n* Have an Investigator Global Assessment of mild to moderate rosacea (IGA rating between 2 and 5 in the Investigator Global Assessment score which includes erythema in the assessment).\n* Access to a computer and the internet.\n\nExclusion Criteria:\n\n* Initiation or change in dose within 4 weeks of baseline of systemic anti-inflammatory medication which may influence study outcome.\n* Use of topical therapy for rosacea within 2 weeks of baseline.\n* Use of systemic corticosteroids within 4 weeks of baseline. Presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.\n* Subjects with known allergy or sensitivity to bromonidine topical gel, 0.33% or components therein.\n* Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.\n* Subjects with severe cardiovascular disease or vascular insufficiency.'}, 'identificationModule': {'nctId': 'NCT03048058', 'briefTitle': 'Internet Surveys and Their Impact on Adherence for Rosacea', 'nctIdAliases': ['NCT02659670'], 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Internet Surveys and Their Impact on Adherence and Quality of Life to Mirvaso for Rosacea', 'orgStudyIdInfo': {'id': '00036221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'brimonidine topical gel 0.33% & survey', 'description': 'The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication, as well as any additional side effects they may be having from the medication.', 'interventionNames': ['Drug: brimonidine topical gel 0.33% & survey', 'Drug: brimonidine topical gel 0.33% & SOC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'brimonidine topical gel 0.33% & SOC', 'description': 'Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits', 'interventionNames': ['Drug: brimonidine topical gel 0.33% & SOC']}], 'interventions': [{'name': 'brimonidine topical gel 0.33% & survey', 'type': 'DRUG', 'otherNames': ['MIRVASO'], 'description': 'The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication, as well as any additional side effects they may be having from the medication.', 'armGroupLabels': ['brimonidine topical gel 0.33% & survey']}, {'name': 'brimonidine topical gel 0.33% & SOC', 'type': 'DRUG', 'otherNames': ['Mirvaso'], 'description': 'All subjects will receive standard-of-care brimonidine topical gel 0.33%', 'armGroupLabels': ['brimonidine topical gel 0.33% & SOC', 'brimonidine topical gel 0.33% & survey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dept of Dermatology, WFUHS', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Steve Feldman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}