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Internet Surveys and Their Impact on Adherence for Rosacea

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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:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048058


Locations
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United States, North Carolina
Dept of Dermatology, WFUHS
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Steve Feldman, MD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03048058     History of Changes
Obsolete Identifiers: NCT02659670
Other Study ID Numbers: 00036221
First Posted: February 9, 2017    Key Record Dates
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

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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:
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Brimonidine Tartrate
Rosacea
Skin Diseases
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