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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.
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.
At 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| brimonidine topical gel 0.33% & survey | Experimental | 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. |
|
| brimonidine topical gel 0.33% & SOC | Active Comparator | Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brimonidine topical gel 0.33% & survey | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence (% of Prescribed Doses That Were Actually Taken by the Subject) | 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Count | Change in total Lesion count | Baseline and 6 months |
| Clinician Erythema Assessment Scale | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Feldman, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Dermatology, WFUHS | Winston-Salem | North Carolina | 27157 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brimonidine 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, as well as any additional side effects they may be having from the medication. brimonidine 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, |
| FG001 | Brimonidine Topical Gel 0.33% & SOC | Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits brimonidine topical gel 0.33% & SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33% |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brimonidine 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, as well as any additional side effects they may be having from the medication. brimonidine 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, |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence (% of Prescribed Doses That Were Actually Taken by the Subject) | 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 | Posted | Median | Standard Deviation | percentage of medication use | 6 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brimonidine Topical Gel 0.33% & Survey | brimonidine topical gel 0.33% & survey adverse events |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Irma M. RIchardson, MHA; | Wake Forest University Health Sciences | 336-716-2903 | irichard@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2016 | Jun 26, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
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| brimonidine topical gel 0.33% & SOC | Drug | All subjects will receive standard-of-care brimonidine topical gel 0.33% |
|
|
| baseline and 6 months |
| Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities) | 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. | baseline and 6 months |
| Patient Severity Assessment (PSA) | 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. | baseline and 6 months |
| Quality of Life With Rosacea | Quality of life for rosacea was reported. The score range is 4-40 with higher scores denoting worse outcomes. | baseline and 6 months |
| Dermatology Life Quality Index | 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. | baseline and 6 months |
| BG001 | Brimonidine Topical Gel 0.33% & SOC | Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits brimonidine topical gel 0.33% & SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33% |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Gender not collected for all participants | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Lesion Count | Change in total Lesion count | Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months | Posted | Mean | Standard Deviation | count of lesions | Baseline and 6 months |
|
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| Secondary | Clinician Erythema Assessment Scale | 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. | Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 months |
|
|
|
| Secondary | Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities) | 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. | Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 months |
|
|
|
| Secondary | Patient Severity Assessment (PSA) | 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. | Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 months |
|
|
|
| Secondary | Quality of Life With Rosacea | Quality of life for rosacea was reported. The score range is 4-40 with higher scores denoting worse outcomes. | Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 months |
|
|
|
| Secondary | Dermatology Life Quality Index | 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. | No data was collected | Posted | baseline and 6 months |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Brimonidine Topical Gel 0.33% & SOC | Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits | 0 | 10 | 0 | 10 | 0 | 10 |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| 6 Months |
|
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| 6 Months |
|
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| 6 Months |
|
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| 6 Months |
|
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| 6 Months |
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