Internet Surveys and Their Impact on Adherence for Rosacea

Study Overview
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Brief Summary
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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.

Detailed Description
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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.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.

Official Title
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Internet Surveys and Their Impact on Adherence and Quality of Life to Mirvaso for Rosacea

Conditions
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Rosacea

Intervention / Treatment
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* Drug: brimonidine topical gel 0.33% & survey
* Drug: brimonidine topical gel 0.33% & SOC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subject with persistent erythema associated with rosacea, age greater than 18, who agrees to participate and provide written consent. 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). Access to a computer and the internet. Exclusion Criteria: Initiation or change in dose within 4 weeks of baseline of systemic anti-inflammatory medication which may influence study outcome. Use of topical therapy for rosacea within 2 weeks of baseline. 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. Subjects with known allergy or sensitivity to bromonidine topical gel, 0.33% or components therein. 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. Subjects with severe cardiovascular disease or vascular insufficiency.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: brimonidine topical gel 0.33% & survey<br>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. | Drug: brimonidine topical gel 0.33% & survey<br>* 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.<br>* Other names: MIRVASO;Drug: brimonidine topical gel 0.33% & SOC<br>* All subjects will receive standard-of-care brimonidine topical gel 0.33%<br>* Other names: Mirvaso;|
| Active Comparator: brimonidine topical gel 0.33% & SOC<br>Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits | Drug: brimonidine topical gel 0.33% & SOC<br>* All subjects will receive standard-of-care brimonidine topical gel 0.33%<br>* Other names: Mirvaso;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |