Clinical trial NCT03048058: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rosacea
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)
timeFrame: 6 months
Secondary outcomes:
measure: Lesion Count
timeFrame: Baseline and 6 months
measure: Clinician Erythema Assessment Scale
timeFrame: baseline and 6 months
measure: Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities)
timeFrame: baseline and 6 months
measure: Patient Severity Assessment (PSA)
timeFrame: baseline and 6 months
measure: Quality of Life With Rosacea
timeFrame: baseline and 6 months
measure: Dermatology Life Quality Index
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Dept of Dermatology, WFUHS
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steve Feldman, MD
role: PRINCIPAL_INVESTIGATOR
References: