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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 Questionnaire

Subject 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

Page last updated: August 20, 2015

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