Internet Surveys and Their Impact on Adherence for Rosacea

NCT ID: NCT03048058

Last Updated: 2018-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-05
• Study Completion Date: 2017-06-30

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.

Conditions

Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

brimonidine topical gel 0.33% & survey

Intervention Type: DRUG

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% & SOC

Intervention Type: DRUG

All subjects will receive standard-of-care brimonidine topical gel 0.33%

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

Group Type: ACTIVE_COMPARATOR

brimonidine topical gel 0.33% & SOC

Intervention Type: DRUG

All subjects will receive standard-of-care brimonidine topical gel 0.33%

Interventions

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.

Intervention Type: DRUG

brimonidine topical gel 0.33% & SOC

All subjects will receive standard-of-care brimonidine topical gel 0.33%

Intervention Type: DRUG

Other Intervention Names

MIRVASO; Mirvaso

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Feldman, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Dept of Dermatology, WFUHS

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

00036221

Identifier Type: -

Identifier Source: org_study_id

NCT02659670

Identifier Type: -

Identifier Source: nct_alias