Internet Surveys and Their Impact on Adherence for Rosacea
Status: | Completed |
---|---|
Conditions: | Cosmetic |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/12/2018 |
Start Date: | May 5, 2016 |
End Date: | June 2017 |
Internet Surveys and Their Impact on Adherence and Quality of Life to Mirvaso for Rosacea
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.
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.
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.
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.
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