Mirvaso in Use Study

NCT02249065 | Completed Phase 4 Results

• 1 other identifier: GLI.04.SPR.US 10305
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 12

Brief Summary

This study is designed to:

1. 1.assess the signs and symptoms of rosacea, including erythema, without treatment and during treatment with Mirvaso® gel
2. 2.further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment
3. 3.gain a better understanding of the real-world use of Mirvaso® on the pattern and management of facial erythema of rosacea.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

• Pre-Treatment Clinician Erythema Assessment (CEA)

  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 Outcomes (4)

• Subject Facial Redness Questionnaire

  14 days (Day 1 (Baseline) and Day 14/Exit)

• Subject Treatment Satisfaction Questionnaire

  14 days (Day 14/Exit)

• Facial Redness Visual Analog Scale (VAS)

  14 days (Day 1 (Baseline), Day 14/Exit)

• Inflammatory Lesions

  14 days (Day 1 (Baseline) and Day 14/Exit)

Study Arms (1)

Mirvaso Gel

EXPERIMENTAL

Brimonidine topical gel, 0.33%

Drug: Brimonidine

Interventions

Brimonidine DRUG

Also known as: Mirvaso Gel

Mirvaso Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (12)

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

Blue Harbor Dermatology

Newport Beach, California, 92663, United States

Location

Center for Dermatology and Laser Surgery

Sacramento, California, 95819, United States

Location

Redwood Dermatology Research

Santa Rosa, California, 95403, United States

Location

Florida Academic Dermatology Center

Miami, Florida, 33136, United States

Location

Research Institute of the Southeast

West Palm Beach, Florida, 33401, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Advanced Skin Research Center

Omaha, Nebraska, 68144, United States

Location

Manhattan Dermatology and Cosmetic Surgery

New York, New York, 10017, United States

Location

DermDox Centers for Dermatology

Hazleton, Pennsylvania, 18201, United States

Location

Arlington Research Center

Arlington, Texas, 76011, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Open label, single arm, short duration.

Results Point of Contact

• Title: Dr. Jean Philippe York
• Organization: Galderma Laboratories L.P.

jp.york@galderma.com

817-961-5468

Study Officials

• Jeffrey Sugarman, MD

  Redwood Dermatology Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 1, 2022
• Results First Posted: October 19, 2017

Record last verified: 2017-11

Locations

US (12)