Internet Surveys and Their Impact on Adherence for Rosacea

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.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: brimonidine topical gel 0.33% & survey; Drug: brimonidine topical gel 0.33% & SOC

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Dept of Dermatology, WFUHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: MIRVASO; Drug: brimonidine topical gel 0.33% & SOC; All subjects will receive standard-of-care brimonidine topical gel 0.33%; Other Names: Mirvaso
Active Comparator: 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	Drug: brimonidine topical gel 0.33% & SOC; All subjects will receive standard-of-care brimonidine topical gel 0.33%; Other Names: Mirvaso

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion Count	Change in total Lesion count	Baseline and 6 months
Clinician Erythema Assessment Scale	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.	baseline and 6 months
Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities)	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.	baseline and 6 months
Patient Severity Assessment (PSA)	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.	baseline and 6 months
Quality of Life With Rosacea	Quality of life for rosacea was reported. The score range is 4-40 with higher scores denoting worse outcomes.	baseline and 6 months
Dermatology Life Quality Index	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.	baseline and 6 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Steve Feldman, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Brimonidine Tartrate
• Other Study ID Numbers: 00036221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No