Internet Surveys and Their Impact on Adherence to Brimonidine Topical Gel and QOL in Patients With Rosacea

Primary Objective: To assess adherence to topical brimonidine for the treatment of rosacea.

Secondary Objectives: To determine the impact of reported adherence on rosacea outcomes, To
identify factors that affect adherence to rosacea treatment and to assess QOL.

Study Design

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. Before starting treatment, subjects will be
reminded that brimonidine is indicated for persistent, not transient, erythema. Subjects will
be given a copy of the product package insert and a copy of the American Academy of
Dermatology website (www.aad.org) information on rosacea that contains standardized
information about the diagnosis and triggers.

Subjects with persistent erythema due to rosacea will be recruited from the Wake Forest
Baptist Health Dermatology Clinic and IRB approved advertising. At the baseline screening
visit, subjects will have the diagnosis of rosacea confirmed by an investigator. Subjects
will be classified as having erythematotelangiectatic or a combination
erythematotelangiectatic and papulopustular. The Investigator will evaluate whether subjects
believe they have constant erythema or more intermittent flushing and blushing. Subjects will
be informed of the benefits and risks of treatment as indicated in the package insert. If
they agree to participate, the subjects will give written consent approved by the
Institutional Review Board and will be seen in follow up at 3 months and 6 months.

Subjects will be randomized (according to standard randomization tables)1:1 to be in the
weekly internet survey group or the standard care non-survey group. 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 it, as well as any additional side effects they
may be having from the medication. Subjects in the non-internet survey group will just get
these identical surveys at the Month 3 and Month 6 visits. The Investigator is also
interested in learning through the adherence surveys if subjects begin using the medication
on an as needed basis, and if this affects the side effect profile and satisfaction with the
medication.

At each visit, review of the internet survey use and medication weights will be done. Disease
severity measures (CEA, PSA, lesion counts) will be obtained. Investigator and subject VAS
scales to measure facial erythema will be obtained. Adverse events will be logged at every
visit. Attention will be paid to any symptoms of rebound erythema and more detailed
information concerning location and timing will be collected. The lesion counts will also
measure any papules or telangiectasia that may become more readily visible with the
improvement in background erythema. Telangiectasia will be counted individually by facial
quadrant as noted in the Lesion Count Appendix. Measuring individual visible telangiectasia
is important as subjects may confuse these with underlying erythema of rosacea, thus
affecting subject assessment of their disease. QOL surveys will be completed at the end of
study visit.

Descriptive statistics will be generated with mean ± standard deviation (S.D.) or median
(interquartile range) for continuous measures depending on the distribution of the data and
frequency distribution for categorical variables. Estimate for adherence rates will be
obtained as the mean adherence rate along with the corresponding 95% confidence interval.

Inclusion Criteria:

- Male or female subject with mild to moderate 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 brimonidine 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.