Rosacea
Conditions
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.
Interventions
DRUGbrimonidine 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.
DRUGbrimonidine topical gel 0.33% & SOC
All subjects will receive standard-of-care brimonidine topical gel 0.33%
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence (% of Prescribed Doses That Were Actually Taken by the Subject) | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinician Erythema Assessment Scale | 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) | 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. |
| Lesion Count | Baseline and 6 months | Change in total Lesion count |
| Quality of Life With Rosacea | 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 | 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. |
| Patient Severity Assessment (PSA) | 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. |
Countries
United States
Participant flow
Recruitment details
20 subjects male/female aged 18 years and older with the diagnosis of persistent erythema associated with mild to moderate rosacea as defined by an Investigator Global Assessment rating between 2 and 5. Patients were recruited from Wake Forest University Department of Dermatology Clinics and via Institutional Review Board approved advertising.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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, | 10 |
| 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
brimonidine topical gel 0.33% & SOC: All subjects will receive standard-of-care brimonidine topical gel 0.33% | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Brimonidine Topical Gel 0.33% & Survey | Brimonidine Topical Gel 0.33% & SOC | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 8 Participants | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 10 Participants | 20 Participants |
| Region of Enrollment United States | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)
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
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Brimonidine Topical Gel 0.33% & Survey | Adherence (% of Prescribed Doses That Were Actually Taken by the Subject) | 8.2 percentage of medication use | Standard Deviation 5.3 |
| Brimonidine Topical Gel 0.33% & SOC | Adherence (% of Prescribed Doses That Were Actually Taken by the Subject) | 6.9 percentage of medication use | Standard Deviation 4.2 |
Secondary
Clinician Erythema Assessment Scale
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.
Time frame: baseline and 6 months
Population: Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine Topical Gel 0.33% & Survey | Clinician Erythema Assessment Scale | Baseline | 2.4 units on a scale | Standard Deviation 0.5 |
| Brimonidine Topical Gel 0.33% & Survey | Clinician Erythema Assessment Scale | 6 Months | 2.7 units on a scale | Standard Deviation 2.8 |
| Brimonidine Topical Gel 0.33% & SOC | Clinician Erythema Assessment Scale | Baseline | 2.5 units on a scale | Standard Deviation 0.53 |
| Brimonidine Topical Gel 0.33% & SOC | Clinician Erythema Assessment Scale | 6 Months | 2.3 units on a scale | Standard Deviation 0.52 |
Secondary
Dermatology Life Quality Index
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.
Time frame: baseline and 6 months
Population: No data was collected
Secondary
Lesion Count
Change in total Lesion count
Time frame: Baseline and 6 months
Population: Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine Topical Gel 0.33% & Survey | Lesion Count | Baseline | 4 count of lesions | Standard Deviation 9.6 |
| Brimonidine Topical Gel 0.33% & Survey | Lesion Count | 6 Months | 2.7 count of lesions | Standard Deviation 2.9 |
| Brimonidine Topical Gel 0.33% & SOC | Lesion Count | Baseline | 10.4 count of lesions | Standard Deviation 17.6 |
| Brimonidine Topical Gel 0.33% & SOC | Lesion Count | 6 Months | 6.2 count of lesions | Standard Deviation 6.7 |
Secondary
Patient Severity Assessment (PSA)
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.
Time frame: baseline and 6 months
Population: Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine Topical Gel 0.33% & Survey | Patient Severity Assessment (PSA) | Baseline | 1.6 units on a scale | Standard Deviation 0.7 |
| Brimonidine Topical Gel 0.33% & Survey | Patient Severity Assessment (PSA) | 6 Months | 1.14 units on a scale | Standard Deviation 0.9 |
| Brimonidine Topical Gel 0.33% & SOC | Patient Severity Assessment (PSA) | Baseline | 2.4 units on a scale | Standard Deviation 1.26 |
| Brimonidine Topical Gel 0.33% & SOC | Patient Severity Assessment (PSA) | 6 Months | 1.17 units on a scale | Standard Deviation 0.98 |
Secondary
Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities)
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.
Time frame: baseline and 6 months
Population: Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine Topical Gel 0.33% & Survey | Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities) | Baseline | 2.4 units on a scale | Standard Deviation 2.12 |
| Brimonidine Topical Gel 0.33% & Survey | Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities) | 6 Months | 1.43 units on a scale | Standard Deviation 1.72 |
| Brimonidine Topical Gel 0.33% & SOC | Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities) | Baseline | 6.2 units on a scale | Standard Deviation 8.66 |
| Brimonidine Topical Gel 0.33% & SOC | Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities) | 6 Months | 1.5 units on a scale | Standard Deviation 1.05 |
Secondary
Quality of Life With Rosacea
Quality of life for rosacea was reported. The score range is 4-40 with higher scores denoting worse outcomes.
Time frame: baseline and 6 months
Population: Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine Topical Gel 0.33% & Survey | Quality of Life With Rosacea | 6 Months | 15.57 units on a scale | Standard Deviation 4.35 |
| Brimonidine Topical Gel 0.33% & Survey | Quality of Life With Rosacea | Baseline | 17.5 units on a scale | Standard Deviation 4.25 |
| Brimonidine Topical Gel 0.33% & SOC | Quality of Life With Rosacea | Baseline | 13.7 units on a scale | Standard Deviation 4.79 |
| Brimonidine Topical Gel 0.33% & SOC | Quality of Life With Rosacea | 6 Months | 13 units on a scale | Standard Deviation 4.1 |