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Mirvaso in Use Study

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ClinicalTrials.gov Identifier: NCT02249065
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : October 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

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.

Condition or disease Intervention/treatment Phase
Rosacea Drug: Brimonidine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MIRVASO® In Use Study: Managing Rosacea Through Assessment and Control of Its Erythema (The MIRACLE Study)
Study Start Date : September 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: Mirvaso Gel
Brimonidine topical gel, 0.33%
Drug: Brimonidine
Other Name: Mirvaso Gel




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. Subject Treatment Satisfaction Questionnaire [ Time Frame: 14 days (Day 14/Exit) ]
    Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)

  3. 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

  4. Inflammatory Lesions [ Time Frame: 14 days (Day 1 (Baseline) and Day 14/Exit) ]
    Change from baseline in facial inflammatory lesion count



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249065


Locations
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United States, Arkansas
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
United States, California
Blue Harbor Dermatology
Newport Beach, California, United States, 92663
Center for Dermatology and Laser Surgery
Sacramento, California, United States, 95819
Redwood Dermatology Research
Santa Rosa, California, United States, 95403
United States, Florida
Florida Academic Dermatology Center
Miami, Florida, United States, 33136
Research Institute of the Southeast
West Palm Beach, Florida, United States, 33401
United States, Michigan
Grekin Skin Institute
Warren, Michigan, United States, 48088
United States, Nebraska
Advanced Skin Research Center
Omaha, Nebraska, United States, 68144
United States, New York
Manhattan Dermatology and Cosmetic Surgery
New York, New York, United States, 10017
United States, Pennsylvania
DermDox Centers for Dermatology
Hazleton, Pennsylvania, United States, 18201
United States, Texas
Arlington Research Center
Arlington, Texas, United States, 76011
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
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Principal Investigator: Jeffrey Sugarman, MD Redwood Dermatology Center

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Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT02249065     History of Changes
Other Study ID Numbers: GLI.04.SPR.US 10305
First Posted: September 25, 2014    Key Record Dates
Results First Posted: October 19, 2017
Last Update Posted: December 19, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Brimonidine Tartrate
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs