Mirvaso in Use Study
Information source: Galderma Laboratories, L.P.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rosacea
Intervention: Brimonidine (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Galderma Laboratories, L.P. Official(s) and/or principal investigator(s): Jeffrey Sugarman, MD, Principal Investigator, Affiliation: Redwood Dermatology Center
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 ofMirvaso® on the pattern and
management of facial erythema of rosacea.
Clinical Details
Official title: MIRVASO® In Use Study: Managing Rosacea Through Assessment and Control of Its Erythema (The MIRACLE Study)
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinician Erythema Assessment (CEA)
Secondary outcome: Subject Facial Redness QuestionnaireSubject Treatment Satisfaction Questionnaire Facial redness VAS Inflammatory lesions
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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® (brirnonidine) topical
gel, 0. 33% per package insert.
3. Subjects with a CEA score of~3 at ScreeningNisit 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 UPT at Visit 1 (prior to test
article application) or females of non-childbearing potential (defmed 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 ofRaynaud's syndrome, thromboangiitis obliterans,
orthostatic hypotension, severe cardiovascular disease, cerebral or coronary
insufficiency, renal or hepatic impairment, sclerode1ma, 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%).
I 0. 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.
I4. Subjects with non-stable dose of current (last 60 days) use of prescription rosacea
medications.
I5. 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
Locations and Contacts
Johnson Dermatology, Fort Smith, Arkansas 72916, United States
Blue Harbor Dermatology, Newport Beach, California 92663, United States
Center for Dermatology and Laser Surgery, Sacramento, California 95819, United States
Redwood Dermatology Research, Santa Rosa, California 95403, United States
Florida Academic Dermatology Center, Miami, Florida 33136, United States
Research Institute of the Southeast, West Palm Beach, Florida 33401, United States
Grekin Skin Institute, Warren, Michigan 48088, United States
Advanced Skin Research Center, Omaha, Nebraska 68144, United States
Manhattan Dermatology and Cosmetic Surgery, New York, New York 10017, United States
DermDox Centers for Dermatology, Hazelton, Pennsylvania 18201, United States
Arlington Research Center, Arlington, Texas 76011, United States
Texas Dermatology and Laser Specialists, San Antonio, Texas 78218, United States
Additional Information
Starting date: September 2014
Last updated: August 10, 2015
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