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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

Tracking Information
First Submitted Date  ICMJE February 6, 2017
First Posted Date  ICMJE February 9, 2017
Results First Submitted Date  ICMJE June 29, 2018
Results First Posted Date  ICMJE August 13, 2018
Last Update Posted Date October 10, 2018
Actual Study Start Date  ICMJE May 5, 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03048058 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2018)
  • Lesion Count [ Time Frame: Baseline and 6 months ]
    Change in total Lesion count
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
  • IGA (on a scale of 0-6) [ Time Frame: 6 months ]
    Overall investigator assessment of rosacea severity based on a scale of 0-6 with 0 being no rosacea and 6 being very severe rosacea
  • Lesion Count [ Time Frame: 6 months ]
    Reduction in total Lesion count
  • Clinician Erythema Assessment Scale [ Time Frame: 6 months ]
    Clinician Erythema Assessment scale based on scale of 0-4 with 0 being no erythema and 4 being severe erythema
  • Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities) [ Time Frame: 6 months ]
    Change in overall Quality of Life as measured by general survey of impact of rosacea on everyday activities
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Internet Surveys and Their Impact on Adherence for Rosacea
Official Title  ICMJE Internet Surveys and Their Impact on Adherence and Quality of Life to Mirvaso for Rosacea
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Condition  ICMJE Rosacea
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: brimonidine topical gel 0.33% & survey
    • Drug: brimonidine topical gel 0.33% & SOC
  • 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
    Intervention: Drug: brimonidine topical gel 0.33% & SOC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2017)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03048058
Other Study ID Numbers  ICMJE 00036221
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steve Feldman, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP