Overview
Internet Surveys and Their Impact on Adherence for Rosacea
Status:
Completed
Completed
Trial end date:
2017-06-01
2017-06-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Wake Forest University Health SciencesTreatments:
Brimonidine Tartrate
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.