Clinical trial NCT02249065: Mirvaso in Use Study
Official title: MIRVASO® In Use Study: Managing Rosacea Through Assessment and Control of Its Erythema (The MIRACLE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rosacea
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pre-Treatment Clinician Erythema Assessment (CEA)
timeFrame: 14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)
Secondary outcomes:
measure: Subject Facial Redness Questionnaire
timeFrame: 14 days (Day 1 (Baseline) and Day 14/Exit)
measure: Subject Treatment Satisfaction Questionnaire
timeFrame: 14 days (Day 14/Exit)
measure: Facial Redness Visual Analog Scale (VAS)
timeFrame: 14 days (Day 1 (Baseline), Day 14/Exit)
measure: Inflammatory Lesions
timeFrame: 14 days (Day 1 (Baseline) and Day 14/Exit)
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Newport Beach
country: United States
facility: Blue Harbor Dermatology
state: California
city: Sacramento
country: United States
facility: Center for Dermatology and Laser Surgery
state: California
city: Santa Rosa
country: United States
facility: Redwood Dermatology Research
state: California
city: Miami
country: United States
facility: Florida Academic Dermatology Center
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast
state: Florida
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Omaha
country: United States
facility: Advanced Skin Research Center
state: Nebraska
city: New York
country: United States
facility: Manhattan Dermatology and Cosmetic Surgery
state: New York
city: Hazleton
country: United States
facility: DermDox Centers for Dermatology
state: Pennsylvania
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
Study officials:
affiliation: Redwood Dermatology Center
name: Jeffrey Sugarman, MD
role: PRINCIPAL_INVESTIGATOR
References: