Internet Surveys and Their Impact on Adherence for Rosacea

• ClinicalTrials.gov Identifier: NCT03048058
• Recruitment Status: Completed
• First Posted: February 9, 2017
• Results First Posted: August 13, 2018
• Last Update Posted: October 10, 2018
• Sponsor: Wake Forest University Health Sciences
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rosacea	Drug: brimonidine topical gel 0.33% & survey; Drug: brimonidine topical gel 0.33% & SOC	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: Internet Surveys and Their Impact on Adherence and Quality of Life to Mirvaso for Rosacea
• Actual Study Start Date: May 5, 2016
• Actual Primary Completion Date: June 2017
• Actual Study Completion Date: June 2017

Arms and Interventions

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 Name: MIRVASO; Drug: brimonidine topical gel 0.33% & SOC; All subjects will receive standard-of-care brimonidine topical gel 0.33%; Other Name: 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 Name: Mirvaso

Outcome Measures

Primary Outcome Measures :

1. Adherence (% of Prescribed Doses That Were Actually Taken by the Subject) [ Time Frame: 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 :

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, North Carolina

Dept of Dermatology, WFUHS

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

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

  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

Study Protocol and Statistical Analysis Plan  [PDF] April 14, 2016

More Information

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03048058
• Obsolete Identifiers: NCT02659670
• Other Study ID Numbers: 00036221
• First Posted: February 9, 2017
• Results First Posted: August 13, 2018
• Last Update Posted: October 10, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Rosacea; Skin Diseases; Brimonidine Tartrate; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs