Internet Surveys and Their Impact on Adherence for Rosacea

Phase 4

Completed

Interventions: Drug: brimonidine topical gel 0.33% & SOC
Drug: brimonidine topical gel 0.33% & survey

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
brimonidine topical gel 0.33% & SOC	brimonidine topical gel 0.33% & SOC	Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits
brimonidine topical gel 0.33% & survey	brimonidine topical gel 0.33% & survey	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.
brimonidine topical gel 0.33% & survey	brimonidine topical gel 0.33% & SOC	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.

Primary Outcome Measures

Name	Time	Method
Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)	6 months	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

Name	Time	Method
Dermatology Life Quality Index	baseline and 6 months	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.
Lesion Count	Baseline and 6 months	Change in total Lesion count
Clinician Erythema Assessment Scale	baseline and 6 months	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)	baseline and 6 months	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)	baseline and 6 months	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	baseline and 6 months	Quality of life for rosacea was reported. The score range is 4-40 with higher scores denoting worse outcomes.

Locations (1): Dept of Dermatology, WFUHS
🇺🇸
Winston-Salem, North Carolina, United States