Rosacea
Conditions
Brief summary
This study is designed to: 1. assess the signs and symptoms of rosacea, including erythema, without treatment and during treatment with Mirvaso® gel 2. further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment 3. gain a better understanding of the real-world use of Mirvaso® on the pattern and management of facial erythema of rosacea.
Interventions
DRUGBrimonidine
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must be 18 years of age or older at time of study consent. 2. Subjects with a board certified dermatologist (BCD) clinical diagnosis of facial erythema of rosacea and eligible for treatment with Mirvaso® (brimonidine) topical gel, 0.33% per package insert. 3. Subjects with a clinician's erythema assessment (CEA) score of \ 3 at Screening Visit 1. 4. Subjects with less than 3 facial inflammatory lesions of rosacea at Screening/Visit 1. 5. Subjects must be willing and able to give written informed consent including photography consent. Consent and photo consent will be obtained prior to any study related procedures 6. Females of childbearing potential with a negative urine pregnancy test (UPT) at Visit 1 (prior to test article application) or females of non-childbearing potential (deemed as post-menopausal \[absence of menstrual bleeding for at least 1 year prior to enrollment\], hysterectomy or bilateral oophorectomy).
Exclusion criteria
1. Subjects with particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia. 2. Subjects with current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjogren's syndrome or depression. 3. Subjects with previous refractive eye surgery such as photorefractive keratectomy, laser-assisted sub-epithelial keratectomy, or laser-assisted in situ keratomileusis. 4. Current treatment with monoamine oxidase inhibitors. 5. Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha- agonists. 6. Less than 3 months (90 days) stable dose treatment with tricyclic antidepressants, cardiac glycosides, beta blockers or other antihypertensive agents. 7. Subjects with any uncontrolled chronic or serious disease or medical condition that would normally prevent participation in a clinical study, or, in the judgment of the investigator, would put the subjects at undue risk, or might confound the study assessments (e.g., other dermatological diseases), or might interfere with the subjects' participation in the study, (e.g., planned hospitalization during the study). 8. Subjects who have received, applied, or taken treatments with drugs, cosmetics or devices known to cause facial erythema and who are deemed ineligible by the investigator. 9. Subjects with known allergies or sensitivities to any component of the study drug, including the active ingredient brimonidine tartrate label (refer to the package insert for Mirvaso® (brimonidine) topical gel, 0.33%). 10. Subjects with prior treatment with brimonidine gel, oxymetazoline or other (topical and/or systemic) alpha adrenergic agonists. 11. Subjects who are pregnant or breast-feeding or planning to become pregnant during the course of the study. 12. Subjects exposed to excessive ultraviolet (UV) radiation within I week prior to baseline and/or subject was unwilling to refrain from excessive exposure to UV radiation during the course of the study. 13. Subjects with the presence of a beard or excessive facial hair that would interfere with the study treatments or study assessments as deemed by the investigator, and refusal to remove beard or facial hair for duration of the study. 14. Subjects with non-stable dose of current (last 60 days) use of prescription rosacea medications. 15. Subjects with uncontrolled rosacea associated with inflammatory pustules and papules. 16. Study site staff, relatives of staff members, or other individuals who would have access to the clinical study protocol. 17. Subjects with participation in any investigational study within 30 days of entry into this study or concomitantly with this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-Treatment Clinician Erythema Assessment (CEA) | 14 days (Day 1 (Baseline), Day 7, and Day 14/Exit) | The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Facial Redness Questionnaire | 14 days (Day 1 (Baseline) and Day 14/Exit) | Facial Redness Questionnaire at Day 1 and Day 14 (Mean Number of Subjects Who's Responses Indicate They Were/Were Not Bothered By Facial Redness, Across All 11 Facial Redness Questions) |
| Subject Treatment Satisfaction Questionnaire | 14 days (Day 14/Exit) | Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions) |
| Facial Redness Visual Analog Scale (VAS) | 14 days (Day 1 (Baseline), Day 14/Exit) | The number and percent of subjects in each transformed response category for the in-office subject reported facial redness VAS |
| Inflammatory Lesions | 14 days (Day 1 (Baseline) and Day 14/Exit) | Change from baseline in facial inflammatory lesion count |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mirvaso Gel Brimonidine Gel | 181 |
| Total | 181 |
Baseline characteristics
| Characteristic | Mirvaso Gel |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 38 Participants |
| Age, Categorical Between 18 and 65 years | 143 Participants |
| Age, Continuous | 52.4 years |
| Region of Enrollment United States | 181 Participants |
| Sex: Female, Male Female | 136 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 68 / 181 |
| serious Total, serious adverse events | 3 / 181 |
Outcome results
Primary
Pre-Treatment Clinician Erythema Assessment (CEA)
The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application.
Time frame: 14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)
Population: Intent-to-treat (ITT) Population; Subjects who received at least 1 application of study drug, and completed at least 1 assessment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 7 | Clear Skin | 3 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 7 | Almost Clear | 18 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 1 (Baseline) | Clear Skin | 0 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 1 (Baseline) | Almost Clear | 0 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 1 (Baseline) | Mild Erythema | 7 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 1 (Baseline) | Moderate Erythema | 144 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 1 (Baseline) | Severe Erythema | 30 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 1 (Baseline) | Missing | 0 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 7 | Mild Erythema | 39 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 7 | Moderate Erythema | 84 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 7 | Severe Erythema | 24 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 7 | Missing | 13 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 14 | Clear Skin | 4 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 14 | Almost Clear | 25 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 14 | Mild Erythema | 39 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 14 | Moderate Erythema | 86 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 14 | Severe Erythema | 27 Participants |
| Mirvaso Gel | Pre-Treatment Clinician Erythema Assessment (CEA) | Day 14 | Missing | 0 Participants |
Secondary
Facial Redness Visual Analog Scale (VAS)
The number and percent of subjects in each transformed response category for the in-office subject reported facial redness VAS
Time frame: 14 days (Day 1 (Baseline), Day 14/Exit)
Population: ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Mirvaso Gel | Facial Redness Visual Analog Scale (VAS) | Day 1 | Very Mild | 31 Participants |
| Mirvaso Gel | Facial Redness Visual Analog Scale (VAS) | Day 1 | Mild | 57 Participants |
| Mirvaso Gel | Facial Redness Visual Analog Scale (VAS) | Day 1 | None | 1 Participants |
| Mirvaso Gel | Facial Redness Visual Analog Scale (VAS) | Day 1 | Moderate | 48 Participants |
| Mirvaso Gel | Facial Redness Visual Analog Scale (VAS) | Day 1 | Severe | 38 Participants |
| Mirvaso Gel | Facial Redness Visual Analog Scale (VAS) | Day 1 | Very Severe | 6 Participants |
| Mirvaso Gel | Facial Redness Visual Analog Scale (VAS) | Day 14 | None | 1 Participants |
| Mirvaso Gel | Facial Redness Visual Analog Scale (VAS) | Day 14 | Very Mild | 63 Participants |
| Mirvaso Gel | Facial Redness Visual Analog Scale (VAS) | Day 14 | Mild | 45 Participants |
| Mirvaso Gel | Facial Redness Visual Analog Scale (VAS) | Day 14 | Moderate | 44 Participants |
| Mirvaso Gel | Facial Redness Visual Analog Scale (VAS) | Day 14 | Severe | 22 Participants |
| Mirvaso Gel | Facial Redness Visual Analog Scale (VAS) | Day 14 | Very Severe | 6 Participants |
Secondary
Inflammatory Lesions
Change from baseline in facial inflammatory lesion count
Time frame: 14 days (Day 1 (Baseline) and Day 14/Exit)
Population: ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirvaso Gel | Inflammatory Lesions | Day 1: Lesions | .6 lesions | Standard Deviation 1.2 |
| Mirvaso Gel | Inflammatory Lesions | Day 14: Lesions | 1.5 lesions | Standard Deviation 4.4 |
| Mirvaso Gel | Inflammatory Lesions | Day 14: Change From Baseline | 1 lesions | Standard Deviation 3.9 |
Secondary
Subject Facial Redness Questionnaire
Facial Redness Questionnaire at Day 1 and Day 14 (Mean Number of Subjects Who's Responses Indicate They Were/Were Not Bothered By Facial Redness, Across All 11 Facial Redness Questions)
Time frame: 14 days (Day 1 (Baseline) and Day 14/Exit)
Population: ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirvaso Gel | Subject Facial Redness Questionnaire | Not Bothered (Mean [SD], Day 1, Baseline) | 75.3 Participants | Standard Deviation 39.4 |
| Mirvaso Gel | Subject Facial Redness Questionnaire | Bothered (Mean [SD], Day 1, Baseline) | 104.7 Participants | Standard Deviation 40.3 |
| Mirvaso Gel | Subject Facial Redness Questionnaire | Missing (Day 1, Baseline) | 1 Participants | Standard Deviation 0 |
| Mirvaso Gel | Subject Facial Redness Questionnaire | Not Bothered (Mean [SD], Day 14) | 112.6 Participants | Standard Deviation 28.9 |
| Mirvaso Gel | Subject Facial Redness Questionnaire | Bothered (Mean [SD], Day 14) | 67.3 Participants | Standard Deviation 26.2 |
| Mirvaso Gel | Subject Facial Redness Questionnaire | Missing (Day 14) | 1.1 Participants | Standard Deviation 0.3 |
Secondary
Subject Treatment Satisfaction Questionnaire
Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)
Time frame: 14 days (Day 14/Exit)
Population: ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mirvaso Gel | Subject Treatment Satisfaction Questionnaire | Satisfied Participants (Mean [SD]) | 127.3 Participants | Standard Deviation 22.2 |
| Mirvaso Gel | Subject Treatment Satisfaction Questionnaire | Dissatisfied Participants (Mean [SD]) | 52.7 Participants | Standard Deviation 22.2 |
| Mirvaso Gel | Subject Treatment Satisfaction Questionnaire | Missing | 1.0 Participants | Standard Deviation 0 |