Back to resultsInternet Surveys and Their Impact on Adherence for Rosacea
Primary Purpose
Rosacea
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
brimonidine topical gel 0.33% & survey
brimonidine topical gel 0.33% & SOC
Sponsored by
About this trial
This is an interventional other trial for Rosacea
Eligibility Criteria
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.
Sites / Locations
- Dept of Dermatology, WFUHS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
brimonidine topical gel 0.33% & survey
brimonidine topical gel 0.33% & SOC
Arm 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.
Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Lesion Count
Change in total Lesion count
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.
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.
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.
Quality of Life With Rosacea
Quality of life for rosacea was reported. The score range is 4-40 with higher scores denoting worse outcomes.
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.
Full Information
NCT ID
NCT03048058
First Posted
February 6, 2017
Last Updated
September 10, 2018
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03048058
Brief Title
Internet Surveys and Their Impact on Adherence for Rosacea
Official Title
Internet Surveys and Their Impact on Adherence and Quality of Life to Mirvaso for Rosacea
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 5, 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
brimonidine topical gel 0.33% & survey
Arm Type
Experimental
Arm 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.
Arm Title
brimonidine topical gel 0.33% & SOC
Arm Type
Active Comparator
Arm Description
Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits
Intervention Type
Drug
Intervention Name(s)
brimonidine topical gel 0.33% & survey
Other Intervention Name(s)
MIRVASO
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
brimonidine topical gel 0.33% & SOC
Other Intervention Name(s)
Mirvaso
Intervention Description
All subjects will receive standard-of-care brimonidine topical gel 0.33%
Primary Outcome Measure Information:
Title
Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Lesion Count
Description
Change in total Lesion count
Time Frame
Baseline and 6 months
Title
Clinician Erythema Assessment Scale
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.
Time Frame
baseline and 6 months
Title
Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities)
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.
Time Frame
baseline and 6 months
Title
Patient Severity Assessment (PSA)
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.
Time Frame
baseline and 6 months
Title
Quality of Life With Rosacea
Description
Quality of life for rosacea was reported. The score range is 4-40 with higher scores denoting worse outcomes.
Time Frame
baseline and 6 months
Title
Dermatology Life Quality Index
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.
Time Frame
baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Feldman, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Dermatology, WFUHS
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Internet Surveys and Their Impact on Adherence for Rosacea
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