Internet Surveys and Their Impact on Adherence to Brimonidine Topical Gel and QOL in Patients With Rosacea

Rosacea Clinical Trial

Official title:

Internet Surveys and Their Impact on Adherence to Brimonidine Topical Gel and QOL in Patients With Rosacea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02659670
• Other study ID #: IRB00036221
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: June 2018
• Source: Wake Forest University Health Sciences
• Contact: Susie Dowb
• Phone: 336-716-2011
• Email: sdowd[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Subjects with persistent erythema associated with rosacea will be recruited from the Wake Forest Baptist Health Dermatology Clinics and IRB approved advertising. At the baseline screening visit, subjects will have the diagnosis of rosacea confirmed by an investigator. Subjects will be classified as having erythematotelangiectatic or a combination erythematotelangiectatic and papulopustular. Study staff will evaluate whether subjects believe they have constant erythema or more intermittent flushing and blushing. Subjects will be informed of the benefits and risks of treatment. If they agree to participate, the subjects will give written consent approved by the Institutional Review Board and will be seen in follow up at 3 months and 6 months.

Subjects will be randomized 1:1 to be in the weekly internet survey group or the standard care non-survey group. 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. Subjects 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.

Subjects in the non-internet survey group will just get these identical surveys at the Month 3 and Month 6 visits. The Investigator is also interested in learning through the adherence surveys if subjects begin using the medication on an as needed basis, and if this affects the side effect profile and satisfaction with the medication.

Description:

Primary Objective: To assess adherence to topical brimonidine for the treatment of rosacea.

Secondary Objectives: To determine the impact of reported adherence on rosacea outcomes, To identify factors that affect adherence to rosacea treatment and to assess QOL.

Study Design

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. Before starting treatment, subjects will be reminded that brimonidine is indicated for persistent, not transient, erythema. Subjects will be given a copy of the product package insert and a copy of the American Academy of Dermatology website (www.aad.org) information on rosacea that contains standardized information about the diagnosis and triggers.

Subjects with persistent erythema due to rosacea will be recruited from the Wake Forest Baptist Health Dermatology Clinic and IRB approved advertising. At the baseline screening visit, subjects will have the diagnosis of rosacea confirmed by an investigator. Subjects will be classified as having erythematotelangiectatic or a combination erythematotelangiectatic and papulopustular. The Investigator will evaluate whether subjects believe they have constant erythema or more intermittent flushing and blushing. Subjects will be informed of the benefits and risks of treatment as indicated in the package insert. If they agree to participate, the subjects will give written consent approved by the Institutional Review Board and will be seen in follow up at 3 months and 6 months.

Subjects will be randomized (according to standard randomization tables)1:1 to be in the weekly internet survey group or the standard care non-survey group. 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 it, as well as any additional side effects they may be having from the medication. Subjects in the non-internet survey group will just get these identical surveys at the Month 3 and Month 6 visits. The Investigator is also interested in learning through the adherence surveys if subjects begin using the medication on an as needed basis, and if this affects the side effect profile and satisfaction with the medication.

At each visit, review of the internet survey use and medication weights will be done. Disease severity measures (CEA, PSA, lesion counts) will be obtained. Investigator and subject VAS scales to measure facial erythema will be obtained. Adverse events will be logged at every visit. Attention will be paid to any symptoms of rebound erythema and more detailed information concerning location and timing will be collected. The lesion counts will also measure any papules or telangiectasia that may become more readily visible with the improvement in background erythema. Telangiectasia will be counted individually by facial quadrant as noted in the Lesion Count Appendix. Measuring individual visible telangiectasia is important as subjects may confuse these with underlying erythema of rosacea, thus affecting subject assessment of their disease. QOL surveys will be completed at the end of study visit.

Descriptive statistics will be generated with mean ± standard deviation (S.D.) or median (interquartile range) for continuous measures depending on the distribution of the data and frequency distribution for categorical variables. Estimate for adherence rates will be obtained as the mean adherence rate along with the corresponding 95% confidence interval.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male or female subject with mild to moderate 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 brimonidine 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.

Related Conditions & MeSH terms

• Rosacea

Intervention

Other:
• internet 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%
All subjects will receive standard-of-care brimonidine topical gel 0.33%

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences Dermatology	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Disease severity measure: Clinician Erythema Assessment (CEA) to month 6.	Objective Clinical Efficacy: Investigator ratings of erythema the scale 0 - 4 with 0=clear and 4=severe	screen/baseline, 3 month, 6 month
Primary	Change from baseline Disease severity measure: Patient Severity Assessment (PSA) to month 6.	Subjective Clinical Efficacy: 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	screen/baseline, 3 month, 6 month
Primary	Change from baseline Disease severity measures: Investigator Visual Analogue Scale (VAS) to month 6.	Rating of rosacea redness scaled 0 - 10. 0 = No redness, 5 = moderate redness, 10 = severe redness	screen/baseline, 3 month, 6 month
Primary	Change from baseline Disease severity measure: Lesion Count (Performed by investigator) to month 6.	Count of lesions in each area on face (Forehead, L. cheek, R. Cheek, and chin)	screen/baseline, 3 month, 6 month
Secondary	Change from baseline Subjective Symptom Improvement: Quality of Life Survey to month 6.	A comprehensive questionnaire on how the subject feels with the disease	screen/baseline, 3 month, 6 month
Secondary	Subject survey to identify factors that affect adherence to rosacea treatment	If the subject is randomized to internet survey group they will receive this survey weekly up to 24 weeks; if not in that group they will complete the survey at month 3 and month 6.	up to 24 weeks, month 3, month 6