- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02249065
Mirvaso in Use Study
July 28, 2022 updated by: Galderma R&D
MIRVASO® In Use Study: Managing Rosacea Through Assessment and Control of Its Erythema (The MIRACLE Study)
This study is designed to:
- assess the signs and symptoms of rosacea, including erythema, without treatment and during treatment with Mirvaso® gel
- further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment
- gain a better understanding of the real-world use of Mirvaso® on the pattern and management of facial erythema of rosacea.
Study Overview
Study Type
Interventional
Enrollment (Actual)
205
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Fort Smith, Arkansas, United States, 72916
- Johnson Dermatology
-
-
California
-
Newport Beach, California, United States, 92663
- Blue Harbor Dermatology
-
Sacramento, California, United States, 95819
- Center for Dermatology and Laser Surgery
-
Santa Rosa, California, United States, 95403
- Redwood Dermatology Research
-
-
Florida
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Miami, Florida, United States, 33136
- Florida Academic Dermatology Center
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West Palm Beach, Florida, United States, 33401
- Research Institute of the Southeast
-
-
Michigan
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Warren, Michigan, United States, 48088
- Grekin Skin Institute
-
-
Nebraska
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Omaha, Nebraska, United States, 68144
- Advanced Skin Research Center
-
-
New York
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New York, New York, United States, 10017
- Manhattan Dermatology and Cosmetic Surgery
-
-
Pennsylvania
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Hazleton, Pennsylvania, United States, 18201
- DermDox Centers for Dermatology
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-
Texas
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Arlington, Texas, United States, 76011
- Arlington Research Center
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San Antonio, Texas, United States, 78218
- Texas Dermatology and Laser Specialists
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects must be 18 years of age or older at time of study consent.
- 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.
- Subjects with a clinician's erythema assessment (CEA) score of ~3 at Screening Visit 1.
- Subjects with less than 3 facial inflammatory lesions of rosacea at Screening/Visit 1.
- 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
- 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:
- 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.
- 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.
- Subjects with previous refractive eye surgery such as photorefractive keratectomy, laser-assisted sub-epithelial keratectomy, or laser-assisted in situ keratomileusis.
- Current treatment with monoamine oxidase inhibitors.
- Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha- agonists.
- Less than 3 months (90 days) stable dose treatment with tricyclic antidepressants, cardiac glycosides, beta blockers or other antihypertensive agents.
- 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).
- 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.
- 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%).
- Subjects with prior treatment with brimonidine gel, oxymetazoline or other (topical and/or systemic) alpha adrenergic agonists.
- Subjects who are pregnant or breast-feeding or planning to become pregnant during the course of the study.
- 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.
- 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.
- Subjects with non-stable dose of current (last 60 days) use of prescription rosacea medications.
- Subjects with uncontrolled rosacea associated with inflammatory pustules and papules.
- Study site staff, relatives of staff members, or other individuals who would have access to the clinical study protocol.
- Subjects with participation in any investigational study within 30 days of entry into this study or concomitantly with this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mirvaso Gel
Brimonidine topical gel, 0.33%
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre-Treatment Clinician Erythema Assessment (CEA)
Time Frame: 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.
|
14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Facial Redness Questionnaire
Time Frame: 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)
|
14 days (Day 1 (Baseline) and Day 14/Exit)
|
Subject Treatment Satisfaction Questionnaire
Time Frame: 14 days (Day 14/Exit)
|
Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)
|
14 days (Day 14/Exit)
|
Facial Redness Visual Analog Scale (VAS)
Time Frame: 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
|
14 days (Day 1 (Baseline), Day 14/Exit)
|
Inflammatory Lesions
Time Frame: 14 days (Day 1 (Baseline) and Day 14/Exit)
|
Change from baseline in facial inflammatory lesion count
|
14 days (Day 1 (Baseline) and Day 14/Exit)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeffrey Sugarman, MD, Redwood Dermatology Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
September 23, 2014
First Submitted That Met QC Criteria
September 23, 2014
First Posted (Estimate)
September 25, 2014
Study Record Updates
Last Update Posted (Actual)
August 1, 2022
Last Update Submitted That Met QC Criteria
July 28, 2022
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLI.04.SPR.US 10305
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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